Trial Outcomes & Findings for Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. (NCT NCT05631626)
NCT ID: NCT05631626
Last Updated: 2026-07-02
Results Overview
The Permanent Product Measure of Performance-Correct (PERMP-C) is an objective, validated, skill-adjusted 10-minute math test that measures attention and accuracy in ADHD. Performance is measured by the number of math problems answered correctly. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
26 participants
Primary outcome timeframe
Average of the change of the PERMP-C scores from baseline defined as pre-dose score at Visit 8 which was at end of 7-day double-blind period to PERMP-C scores at hour 16 at Visit 8.
Results posted on
2026-07-02
Participant Flow
A total of 26 subjects were enrolled, of which 21 were randomized to double-blind, placebo controlled treatment at one study center from December 29, 2022 to June 6, 2023.
The study included a screening period of up to 4 weeks, followed by a 5-week open-label dose optimization period, followed by a 1-week randomized, placebo-controlled, double-blind period.
Participant milestones
| Measure |
CTx-1301 (Dexmethylphenidate Tablet) Dose Optimization Phase
After a 4 week screening period, all eligible and enrolled subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg. The starting dose for all subjects at Day 0 is 25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
CTx-1301 (Dexmethylphenidate Tablet) Double-Blind Period
Subjects received CTx-1301 at their optimal dose of either 25mg, 37.5mg, or 50mg, once daily during the 1-week randomized, placebo controlled, double-blind period. This was preceded by a 5-week open-label CTx-1301 dose-optimization period.
|
Placebo
Subjects received placebo once daily during the 1-week randomized, placebo-controlled, double-blind period. This was preceded by a 5-week open-label CTx-1301 dose-optimization period.
|
|---|---|---|---|
|
Screening/Dose Optimization (9 Weeks)
STARTED
|
26
|
0
|
0
|
|
Screening/Dose Optimization (9 Weeks)
COMPLETED
|
21
|
0
|
0
|
|
Screening/Dose Optimization (9 Weeks)
NOT COMPLETED
|
5
|
0
|
0
|
|
Double-Blind Period (7 Days)
STARTED
|
0
|
11
|
10
|
|
Double-Blind Period (7 Days)
COMPLETED
|
0
|
11
|
10
|
|
Double-Blind Period (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data collected from dose optimization and double-blind treatment phases are reported in separate rows. Therefore the analysis population numbers are reported separately for each phase and differ from the overall.
Baseline characteristics by cohort
| Measure |
CTx-1301 (Dexmethylphenidate Tablet) Dose Optimization Phase
n=26 Participants
After a 4 week screening period, all eligible and enrolled subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg. The starting dose for all subjects at Day 0 is 25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
CTx-1301 (Dexmethylphenidate Tablet) Double-Blind Period
n=11 Participants
Subjects received CTx-1301 at their optimal dose of either 25mg, 37.5mg, or 50mg, once daily during the 1-week randomized, placebo-controlled, double-blind period. This was preceded by a 5-week open-label CTx-1301 dose-optimization period.
|
Placebo
n=10 Participants
Subjects received placebo once daily during the 1-week randomized, placebo-controlled, double-blind period. This was preceded by a 5-week open-label CTx-1301 dose-optimization period.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 to 55 Dose Optimization Phase
|
26 Participants
n=26 Participants • Data collected from dose optimization and double-blind treatment phases are reported in separate rows. Therefore the analysis population numbers are reported separately for each phase and differ from the overall.
|
0 Participants
Data collected from dose optimization and double-blind treatment phases are reported in separate rows. Therefore the analysis population numbers are reported separately for each phase and differ from the overall.
|
0 Participants
Data collected from dose optimization and double-blind treatment phases are reported in separate rows. Therefore the analysis population numbers are reported separately for each phase and differ from the overall.
|
26 Participants
n=26 Participants • Data collected from dose optimization and double-blind treatment phases are reported in separate rows. Therefore the analysis population numbers are reported separately for each phase and differ from the overall.
|
|
Age, Customized
18 to 55 Double-Blind Treatment Phase
|
0 Participants
Data collected from dose optimization and double-blind treatment phases are reported in separate rows. Therefore the analysis population numbers are reported separately for each phase and differ from the overall.
|
11 Participants
n=11 Participants • Data collected from dose optimization and double-blind treatment phases are reported in separate rows. Therefore the analysis population numbers are reported separately for each phase and differ from the overall.
|
10 Participants
n=10 Participants • Data collected from dose optimization and double-blind treatment phases are reported in separate rows. Therefore the analysis population numbers are reported separately for each phase and differ from the overall.
|
21 Participants
n=21 Participants • Data collected from dose optimization and double-blind treatment phases are reported in separate rows. Therefore the analysis population numbers are reported separately for each phase and differ from the overall.
|
|
Sex: Female, Male
Dose Optimization Phase · Female
|
19 Participants
n=26 Participants • Data collected from dose optimization and double-blind phase are reported in separate rows
|
—
|
—
|
19 Participants
n=26 Participants • Data collected from dose optimization and double-blind phase are reported in separate rows
|
|
Sex: Female, Male
Dose Optimization Phase · Male
|
7 Participants
n=26 Participants • Data collected from dose optimization and double-blind phase are reported in separate rows
|
—
|
—
|
7 Participants
n=26 Participants • Data collected from dose optimization and double-blind phase are reported in separate rows
|
|
Sex: Female, Male
Double-Blind Phase · Female
|
—
|
10 Participants
n=11 Participants • Data collected from dose optimization and double-blind phase are reported in separate rows
|
7 Participants
n=10 Participants • Data collected from dose optimization and double-blind phase are reported in separate rows
|
17 Participants
n=21 Participants • Data collected from dose optimization and double-blind phase are reported in separate rows
|
|
Sex: Female, Male
Double-Blind Phase · Male
|
—
|
1 Participants
n=11 Participants • Data collected from dose optimization and double-blind phase are reported in separate rows
|
3 Participants
n=10 Participants • Data collected from dose optimization and double-blind phase are reported in separate rows
|
4 Participants
n=21 Participants • Data collected from dose optimization and double-blind phase are reported in separate rows
|
|
Ethnicity (NIH/OMB)
Dose Optimization Phase · Hispanic or Latino
|
7 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
—
|
—
|
7 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Ethnicity (NIH/OMB)
Dose Optimization Phase · Not Hispanic or Latino
|
19 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
—
|
—
|
19 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Ethnicity (NIH/OMB)
Dose Optimization Phase · Unknown or Not Reported
|
0 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
—
|
—
|
0 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Ethnicity (NIH/OMB)
Double-Blind Phase · Hispanic or Latino
|
—
|
4 Participants
n=11 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
1 Participants
n=10 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
5 Participants
n=21 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Ethnicity (NIH/OMB)
Double-Blind Phase · Not Hispanic or Latino
|
—
|
7 Participants
n=11 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
9 Participants
n=10 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
16 Participants
n=21 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Ethnicity (NIH/OMB)
Double-Blind Phase · Unknown or Not Reported
|
—
|
0 Participants
n=11 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
0 Participants
n=10 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
0 Participants
n=21 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Dose Optimization Phase · American Indian or Alaska Native
|
0 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
—
|
—
|
0 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Dose Optimization Phase · Asian
|
3 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
—
|
—
|
3 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Dose Optimization Phase · Native Hawaiian or Other Pacific Islander
|
2 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
—
|
—
|
2 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Dose Optimization Phase · Black or African American
|
1 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
—
|
—
|
1 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Dose Optimization Phase · White
|
20 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
—
|
—
|
20 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Dose Optimization Phase · More than one race
|
0 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
—
|
—
|
0 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Dose Optimization Phase · Unknown or Not Reported
|
0 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
—
|
—
|
0 Participants
n=26 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Double-Blind Phase · American Indian or Alaska Native
|
—
|
0 Participants
n=11 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
0 Participants
n=10 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
0 Participants
n=21 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Double-Blind Phase · Asian
|
—
|
1 Participants
n=11 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
2 Participants
n=10 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
3 Participants
n=21 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Double-Blind Phase · Native Hawaiian or Other Pacific Islander
|
—
|
1 Participants
n=11 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
1 Participants
n=10 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
2 Participants
n=21 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Double-Blind Phase · Black or African American
|
—
|
1 Participants
n=11 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
0 Participants
n=10 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
1 Participants
n=21 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Double-Blind Phase · White
|
—
|
8 Participants
n=11 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
7 Participants
n=10 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
15 Participants
n=21 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Double-Blind Phase · More than one race
|
—
|
0 Participants
n=11 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
0 Participants
n=10 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
0 Participants
n=21 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Race (NIH/OMB)
Double-Blind Phase · Unknown or Not Reported
|
—
|
0 Participants
n=11 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
0 Participants
n=10 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
0 Participants
n=21 Participants • Data collected from dose optimization phase and double-blind phase are reported in separate rows.
|
|
Region of Enrollment
United States
|
0 Participants
This number reflects number of subjects in the double-blind phase only.
|
11 Participants
n=11 Participants • This number reflects number of subjects in the double-blind phase only.
|
10 Participants
n=10 Participants • This number reflects number of subjects in the double-blind phase only.
|
21 Participants
n=21 Participants • This number reflects number of subjects in the double-blind phase only.
|
PRIMARY outcome
Timeframe: Average of the change of the PERMP-C scores from baseline defined as pre-dose score at Visit 8 which was at end of 7-day double-blind period to PERMP-C scores at hour 16 at Visit 8.The Permanent Product Measure of Performance-Correct (PERMP-C) is an objective, validated, skill-adjusted 10-minute math test that measures attention and accuracy in ADHD. Performance is measured by the number of math problems answered correctly. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.
Outcome measures
| Measure |
CTx-1301 (Dexmethylphenidate Tablet)
n=11 Participants
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
Placebo
n=10 Participants
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
Placebo Double-Blind Treatment Phase
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
|---|---|---|---|
|
The Primary Efficacy Analysis Will Analyze the Change in PERMP Scores From Baseline (Pre-dose) at Visit 8 to Hour 16 at Visit 8.
|
24.94 score on a scale
Interval 15.474 to 34.415
|
13.09 score on a scale
Interval 3.149 to 23.033
|
—
|
SECONDARY outcome
Timeframe: Average of the change of the PERMP-C scores from baseline defined as pre-dose score at Visit 8 which was at end of 7-day double-blind period to PERMP-C scores at hours .5,1,3,6,9,12,13,14,15, and 16.The Permanent Product Measure of Performance-Correct (PERMP-C) is an objective, validated, skill-adjusted 10-minute math test that measures attention and accuracy in ADHD. Performance is measured by the number of math problems answered correctly. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.
Outcome measures
| Measure |
CTx-1301 (Dexmethylphenidate Tablet)
n=11 Participants
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
Placebo
n=10 Participants
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
Placebo Double-Blind Treatment Phase
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
|---|---|---|---|
|
Key Secondary Analysis Will Analyze the Change in PERMP Scores From Baseline at Each Time Point During the Laboratory Environment at Visit 8.
Hour .5
|
14.4 score on a scale
Interval 7.02 to 21.78
|
7.2 score on a scale
Interval -0.59 to 14.91
|
—
|
|
Key Secondary Analysis Will Analyze the Change in PERMP Scores From Baseline at Each Time Point During the Laboratory Environment at Visit 8.
Hour 1
|
19.2 score on a scale
Interval 11.86 to 26.55
|
10.2 score on a scale
Interval 2.46 to 17.89
|
—
|
|
Key Secondary Analysis Will Analyze the Change in PERMP Scores From Baseline at Each Time Point During the Laboratory Environment at Visit 8.
Hour 3
|
18.6 score on a scale
Interval 8.27 to 28.97
|
7.2 score on a scale
Interval -3.65 to 18.08
|
—
|
|
Key Secondary Analysis Will Analyze the Change in PERMP Scores From Baseline at Each Time Point During the Laboratory Environment at Visit 8.
Hour 6
|
26.8 score on a scale
Interval 18.14 to 33.45
|
11.1 score on a scale
Interval 2.04 to 20.21
|
—
|
|
Key Secondary Analysis Will Analyze the Change in PERMP Scores From Baseline at Each Time Point During the Laboratory Environment at Visit 8.
Hour 9
|
24.7 score on a scale
Interval 13.71 to 35.63
|
7.9 score on a scale
Interval -3.64 to 19.36
|
—
|
|
Key Secondary Analysis Will Analyze the Change in PERMP Scores From Baseline at Each Time Point During the Laboratory Environment at Visit 8.
Hour 12
|
21.4 score on a scale
Interval 9.51 to 33.27
|
14.1 score on a scale
Interval 1.6 to 26.54
|
—
|
|
Key Secondary Analysis Will Analyze the Change in PERMP Scores From Baseline at Each Time Point During the Laboratory Environment at Visit 8.
Hour 13
|
27.8 score on a scale
Interval 14.33 to 41.33
|
18.7 score on a scale
Interval 4.51 to 32.86
|
—
|
|
Key Secondary Analysis Will Analyze the Change in PERMP Scores From Baseline at Each Time Point During the Laboratory Environment at Visit 8.
Hour 14
|
32.4 score on a scale
Interval 17.67 to 47.03
|
19.6 score on a scale
Interval 4.2 to 35.03
|
—
|
|
Key Secondary Analysis Will Analyze the Change in PERMP Scores From Baseline at Each Time Point During the Laboratory Environment at Visit 8.
Hour 15
|
35.3 score on a scale
Interval 20.23 to 50.44
|
16.7 score on a scale
Interval 0.87 to 32.59
|
—
|
|
Key Secondary Analysis Will Analyze the Change in PERMP Scores From Baseline at Each Time Point During the Laboratory Environment at Visit 8.
Hour 16
|
28.8 score on a scale
Interval 13.31 to 44.37
|
18.3 score on a scale
Interval 1.97 to 34.58
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-dose at Visit 2) to Visit 8 (approximately 6 weeks).The Clinical Global Impression-Severity (CGI-S) scale is a 7-point clinician-rated tool that measures the overall severity of a subject's illness. It rates subjects from 1 (normal) to 7 (among the most extremely ill). A higher score means a worse outcome.
Outcome measures
| Measure |
CTx-1301 (Dexmethylphenidate Tablet)
n=11 Participants
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
Placebo
n=10 Participants
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
Placebo Double-Blind Treatment Phase
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
|---|---|---|---|
|
Key Secondary Analysis Will Analyze the Change From Baseline (Pre-dose at Visit 2) of Clinical Global Impression - Severity (CGI-S) Scores to CGI-S at Visit 8.
|
-1.1 score on a scale
Interval -1.4 to -0.79
|
-0.1 score on a scale
Interval -0.42 to 0.23
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening (Visit 1) to Visit 9 (approximately 7-11 weeks, depending on screening window)Treatment Emergent Adverse Events (TEAEs) will be evaluated at each visit
Outcome measures
| Measure |
CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
Placebo
n=11 Participants
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
Placebo Double-Blind Treatment Phase
n=10 Participants
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
|---|---|---|---|
|
Safety - Incidence of TEAEs
AE leading to withdrawal
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Incidence of TEAEs
AE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Incidence of TEAEs
TEAE related to study drug
|
22 Participants
|
1 Participants
|
3 Participants
|
|
Safety - Incidence of TEAEs
Severe TEAE
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Incidence of TEAEs
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Incidence of TEAEs
SAE related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Incidence of TEAEs
TEAE
|
25 Participants
|
1 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-dose) at Visit 8 then post-dose at hours .5,1,3,6,9,12,13,14,15, and 16.The purpose of this study is to estimate the effect size of treatment on the PERMP instrument in an adult ADHD population as defined by the inclusion/exclusion criteria. The Permanent Product Measure of Performance (PERMP) is an objective, validated, skill-adjusted 10-minute math test that measures attention in ADHD. The PERMP correct score comprises the number of math problems answered correctly. A higher PERMP score indicates better performance.Though primary and secondary endpoints are defined in accordance with International Conference on Harmonization (ICH) E9 guidelines, this study is not intended to demonstrate statistical significance via treatment group comparisons.
Outcome measures
| Measure |
CTx-1301 (Dexmethylphenidate Tablet)
n=21 Participants
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
Placebo
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
Placebo Double-Blind Treatment Phase
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
|---|---|---|---|
|
The Purpose of This Study is to Estimate the Effect Size of Treatment on the PERMP Instrument in an Adult ADHD Population as Defined by the Inclusion/Exclusion Criteria.
Hour .5
|
1.41 units on a scale
|
—
|
—
|
|
The Purpose of This Study is to Estimate the Effect Size of Treatment on the PERMP Instrument in an Adult ADHD Population as Defined by the Inclusion/Exclusion Criteria.
Hour 1
|
1.76 units on a scale
|
—
|
—
|
|
The Purpose of This Study is to Estimate the Effect Size of Treatment on the PERMP Instrument in an Adult ADHD Population as Defined by the Inclusion/Exclusion Criteria.
Hour 3
|
1.58 units on a scale
|
—
|
—
|
|
The Purpose of This Study is to Estimate the Effect Size of Treatment on the PERMP Instrument in an Adult ADHD Population as Defined by the Inclusion/Exclusion Criteria.
Hour 6
|
2.60 units on a scale
|
—
|
—
|
|
The Purpose of This Study is to Estimate the Effect Size of Treatment on the PERMP Instrument in an Adult ADHD Population as Defined by the Inclusion/Exclusion Criteria.
Hour 9
|
2.20 units on a scale
|
—
|
—
|
|
The Purpose of This Study is to Estimate the Effect Size of Treatment on the PERMP Instrument in an Adult ADHD Population as Defined by the Inclusion/Exclusion Criteria.
Hour 12
|
0.88 units on a scale
|
—
|
—
|
|
The Purpose of This Study is to Estimate the Effect Size of Treatment on the PERMP Instrument in an Adult ADHD Population as Defined by the Inclusion/Exclusion Criteria.
Hour 13
|
0.97 units on a scale
|
—
|
—
|
|
The Purpose of This Study is to Estimate the Effect Size of Treatment on the PERMP Instrument in an Adult ADHD Population as Defined by the Inclusion/Exclusion Criteria.
Hour 14
|
1.24 units on a scale
|
—
|
—
|
|
The Purpose of This Study is to Estimate the Effect Size of Treatment on the PERMP Instrument in an Adult ADHD Population as Defined by the Inclusion/Exclusion Criteria.
Hour 15
|
1.77 units on a scale
|
—
|
—
|
|
The Purpose of This Study is to Estimate the Effect Size of Treatment on the PERMP Instrument in an Adult ADHD Population as Defined by the Inclusion/Exclusion Criteria.
Hour 16
|
0.98 units on a scale
|
—
|
—
|
Adverse Events
CTx-1301 (Dexmethylphenidate Tablet) Dose Optimization Phase
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
CTx-1301 (Dexmethylphenidate Tablet) Double-Blind Treatment Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CTx-1301 (Dexmethylphenidate Tablet) Dose Optimization Phase
n=26 participants at risk
After a 4-week screening period, all eligible and enrolled subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg. The starting dose for all subjects at Day 0 is 25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
|
CTx-1301 (Dexmethylphenidate Tablet) Double-Blind Treatment Phase
n=11 participants at risk
Subjects received CTx-1301 at their optimal dose of either 25mg, 37.5mg, or 50mg, once daily during the 1-week randomized, placebo-controlled, double-blind period. This was preceded by a 5-week open-label CTx-1301 dose-optimization period.
|
Placebo
n=10 participants at risk
Subjects received placebo once daily during the 1-week randomized, placebo-controlled, double-blind period. This was preceded by a 5-week open-label CTx-1301 dose-optimization period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomting
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Psychiatric disorders
Anxiety
|
42.3%
11/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Psychiatric disorders
Insomnia
|
42.3%
11/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Psychiatric disorders
Irritability
|
26.9%
7/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Psychiatric disorders
Affect Lability
|
11.5%
3/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Gastrointestinal disorders
Dry Mouth
|
57.7%
15/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
4/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
2/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Gastrointestinal disorders
GERD
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
10.0%
1/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Psychiatric disorders
Bruxism
|
7.7%
2/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
9.1%
1/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Psychiatric disorders
Libido Decreased
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Psychiatric disorders
Logorrhoea
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
38.5%
10/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Nervous system disorders
Headache
|
30.8%
8/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
10.0%
1/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Nervous system disorders
Hypoaesthesia
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
10.0%
1/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Nervous system disorders
Tremor
|
0.00%
0/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
10.0%
1/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
General disorders
Feeling Jittery
|
15.4%
4/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
General disorders
Fatigue
|
7.7%
2/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
10.0%
1/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
General disorders
Chest Pain
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
General disorders
Energy Increased
|
0.00%
0/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
9.1%
1/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
15.4%
4/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Infections and infestations
Gastroenteritis Viral
|
11.5%
3/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Infections and infestations
Bronchitis
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Infections and infestations
Laryngitis
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Cardiac disorders
Tachycardia
|
11.5%
3/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Cardiac disorders
Palpitations
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.5%
3/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Ear and labyrinth disorders
Vertigo
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Injury, poisoning and procedural complications
Burns First Degree
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Investigations
Heart Rate Increased
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
|
Vascular disorders
Hot Flush
|
3.8%
1/26 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/11 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
0.00%
0/10 • Screening (Visit 1) to Visit 9 (approximately. 7-11 weeks, depending on screening window)
Adverse events cannot be provided by dose levels (CTx-1301 25mg, CTx-1301 37.5mg, CTx-1301 50mg) in the Dose Optimization and Double-Blind arms as this was not part of the original study design.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER