Trial Outcomes & Findings for Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia (NCT NCT04662281)
NCT ID: NCT04662281
Last Updated: 2026-02-13
Results Overview
ADPS is based on question 5 of Zoster Brief Pain Inventory (ZBPI) and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine. Higher ADPS scores indicates a worse outcome. Negative change from baseline indicates no pain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Baseline (Week 2 of the Run-in period) to Week 6
Results posted on
2026-02-13
Participant Flow
Participants took part in the study at multiple investigative sites from 10 Dec 2020 to 28 Dec 2022.
Following a 2-week single blind Run-in period, a total of 79 participants were randomized and treated in this study.
Participant milestones
| Measure |
Placebo
Following a 2-week Single-blind Run-in period, participants received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
|
LX9211
Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 milligrams (mg) tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
38
|
|
Overall Study
COMPLETED
|
34
|
21
|
|
Overall Study
NOT COMPLETED
|
7
|
17
|
Reasons for withdrawal
| Measure |
Placebo
Following a 2-week Single-blind Run-in period, participants received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
|
LX9211
Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 milligrams (mg) tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
13
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Reason not Specified
|
1
|
2
|
Baseline Characteristics
Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia
Baseline characteristics by cohort
| Measure |
Placebo
n=41 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
|
LX9211
n=38 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 12.5 • n=41 Participants
|
65.4 years
STANDARD_DEVIATION 11.7 • n=1581 Participants
|
64.5 years
STANDARD_DEVIATION 12.1 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=41 Participants
|
23 Participants
n=1581 Participants
|
47 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=41 Participants
|
15 Participants
n=1581 Participants
|
32 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
23 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=41 Participants
|
27 Participants
n=1581 Participants
|
56 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=41 Participants
|
37 Participants
n=1581 Participants
|
76 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 2 of the Run-in period) to Week 6Population: The modified intent to treat (mITT) population included all randomized participants who had taken at least 1 dose of study drug. "Overall number of participants analyzed" is the number of participants analyzed in this outcome measure.
ADPS is based on question 5 of Zoster Brief Pain Inventory (ZBPI) and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine. Higher ADPS scores indicates a worse outcome. Negative change from baseline indicates no pain.
Outcome measures
| Measure |
Placebo
n=36 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
|
LX9211
n=22 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
|
Placebo (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of matching placebo to LX9211 tablet, orally.
|
LX9211 (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of LX9211 tablet, orally.
|
|---|---|---|---|---|
|
Change From Baseline (Week 2 of the Run-in Period) in Average Daily Pain Score (ADPS)
|
-1.62 score on a scale
Standard Error 0.360
|
-2.42 score on a scale
Standard Error 0.397
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: The mITT population included all randomized participants who had taken at least 1 dose of study drug. "Overall number of participants analyzed" is the number of participants analyzed in this outcome measure.
Pain interfering with sleep is based on Question 9F of the ZBPI "Indicate the one number that describes how, in the past 24-hours shingles pain has interfered with your: Sleep; 0 = does not interfere to 10 = Completely interferes. Higher the number, the worsening of sleep due to pain interference. Negative change from baseline indicates no interference in sleep. Pain interfering with sleep was based on the daily pain diary data based on Q 9F of the ZBPI.
Outcome measures
| Measure |
Placebo
n=35 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
|
LX9211
n=22 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
|
Placebo (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of matching placebo to LX9211 tablet, orally.
|
LX9211 (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of LX9211 tablet, orally.
|
|---|---|---|---|---|
|
Change From Baseline in Pain Interfering With Sleep Based on Question 9F of the ZBPI at Week 6
|
-1.43 score on a scale
Standard Error 0.323
|
-2.04 score on a scale
Standard Error 0.364
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: The mITT population included all randomized participants who had taken at least 1 dose of study drug.
ADPS is based on question 5 of Zoster Brief Pain Inventory (ZBPI) and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine. Higher ADPS scores indicated a worse outcome.
Outcome measures
| Measure |
Placebo
n=41 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
|
LX9211
n=38 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
|
Placebo (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of matching placebo to LX9211 tablet, orally.
|
LX9211 (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of LX9211 tablet, orally.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline at Week 6
|
34.15 percentage of participants
|
42.11 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: The mITT population included all randomized participants who had taken at least 1 dose of study drug.
ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine. Higher ADPS scores indicated a worse outcome.
Outcome measures
| Measure |
Placebo
n=41 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
|
LX9211
n=38 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
|
Placebo (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of matching placebo to LX9211 tablet, orally.
|
LX9211 (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of LX9211 tablet, orally.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6
|
19.51 percentage of participants
|
23.68 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: The mITT population included all randomized participants who had taken at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies number of participants analyzed in this outcome measure.
The ZBPI, a 9-item questionnaire, assesses the severity of pain and its impact on functioning in participants with postherpetic neuralgia (PHN). Each question concerning daily activity (General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life) was scored on a scale from 0 to 10, where 0 indicated no interference and 10 indicated complete interference. Higher ZBPI score indicates a worse outcome. Negative change from baseline indicates no interference in all daily activities. The pain interference at Week 6 in this outcome measure was based on data collected on the ZBPI administered at the Week 6 in-person clinic visit.
Outcome measures
| Measure |
Placebo
n=29 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
|
LX9211
n=26 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
|
Placebo (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of matching placebo to LX9211 tablet, orally.
|
LX9211 (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of LX9211 tablet, orally.
|
|---|---|---|---|---|
|
Change From Baseline in Interference in General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life Interference Based on the Questions 9A-G of the ZBPI
General Activity: Change at Week 6
|
-0.52 score on a scale
Standard Error 0.392
|
-1.75 score on a scale
Standard Error 0.417
|
—
|
—
|
|
Change From Baseline in Interference in General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life Interference Based on the Questions 9A-G of the ZBPI
Mood: Change at Week 6
|
-1.52 score on a scale
Standard Error 0.407
|
-2.36 score on a scale
Standard Error 0.435
|
—
|
—
|
|
Change From Baseline in Interference in General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life Interference Based on the Questions 9A-G of the ZBPI
Walking Ability: Change at Week 6
|
-0.28 score on a scale
Standard Error 0.373
|
-0.72 score on a scale
Standard Error 0.391
|
—
|
—
|
|
Change From Baseline in Interference in General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life Interference Based on the Questions 9A-G of the ZBPI
Normal Work: Change at Week 6
|
-0.61 score on a scale
Standard Error 0.383
|
-1.28 score on a scale
Standard Error 0.397
|
—
|
—
|
|
Change From Baseline in Interference in General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life Interference Based on the Questions 9A-G of the ZBPI
Relations With Other People: Change at Week 6
|
-0.89 score on a scale
Standard Error 0.381
|
-1.27 score on a scale
Standard Error 0.400
|
—
|
—
|
|
Change From Baseline in Interference in General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life Interference Based on the Questions 9A-G of the ZBPI
Relations With Sleep: Change at Week 6
|
-1.61 score on a scale
Standard Error 0.370
|
-1.66 score on a scale
Standard Error 0.382
|
—
|
—
|
|
Change From Baseline in Interference in General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life Interference Based on the Questions 9A-G of the ZBPI
Enjoyment of Life: Change at Week 6
|
-1.13 score on a scale
Standard Error 0.405
|
-1.93 score on a scale
Standard Error 0.435
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: The mITT population included all randomized participants who had taken at least 1 dose of study drug.
ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.
Outcome measures
| Measure |
Placebo
n=41 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
|
LX9211
n=38 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
|
Placebo (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of matching placebo to LX9211 tablet, orally.
|
LX9211 (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of LX9211 tablet, orally.
|
|---|---|---|---|---|
|
Number of Participants Discontinuing Treatment Due to Lack of Efficacy Defined as Increase in ADPS From Baseline of ≥30% Based on Question 5 of the ZBPI
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: The mITT population included all randomized participants who had taken at least 1 dose of study drug. "Overall number of participants analyzed" is the number of participants analyzed in this outcome measure.
PGIC is assessed on a 7-point rating scale where 1= very much improved to 7 = very much worse. Higher scores indicate worse outcomes.
Outcome measures
| Measure |
Placebo
n=36 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
|
LX9211
n=27 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
|
Placebo (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of matching placebo to LX9211 tablet, orally.
|
LX9211 (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of LX9211 tablet, orally.
|
|---|---|---|---|---|
|
Patient Global Impression of Change (PGIC) at Week 6
|
3.06 score on a scale
Standard Error 0.222
|
2.65 score on a scale
Standard Error 0.265
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6 to Week 11Population: All enrolled participants. Participants who had at least a 30% reduction in pain intensity in ADPS at Week 6 were analyzed for this outcome measure.
ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.
Outcome measures
| Measure |
Placebo
n=14 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
|
LX9211
n=16 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
|
Placebo (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of matching placebo to LX9211 tablet, orally.
|
LX9211 (Single-blind Placebo Safety Follow-up Period)
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of LX9211 tablet, orally.
|
|---|---|---|---|---|
|
Time to Loss of Efficacy From Week 6 to Week 11 Among Participants Achieving ≥30% Reduction in Pain Intensity in ADPS Based on Question 5 of the ZBPI.
|
NA weeks
The median and full range is not estimable as none of the participants discontinued due to lack of efficacy in safety follow up period (Week 6 to Week 11).
|
NA weeks
The median and full range is not estimable as none of the participants discontinued due to lack of efficacy in safety follow up period (Week 6 to Week 11).
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)Population: The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
Adverse Events (AEs) are defined as any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as any AEs reported after the first dose of double-blind study medication on study Day 1.
Outcome measures
| Measure |
Placebo
n=41 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
|
LX9211
n=38 Participants
Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
|
Placebo (Single-blind Placebo Safety Follow-up Period)
n=38 Participants
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of matching placebo to LX9211 tablet, orally.
|
LX9211 (Single-blind Placebo Safety Follow-up Period)
n=31 Participants
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of LX9211 tablet, orally.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
13 Participants
|
24 Participants
|
9 Participants
|
5 Participants
|
Adverse Events
Placebo (Double-blind Treatment Period)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
LX9211 (Double-blind Treatment Period)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo (Single-blind Placebo Safety Follow-up Period)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LX9211 (Single-blind Placebo Safety Follow-up Period)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (Double-blind Treatment Period)
n=41 participants at risk
Following a 2-week Single-blind Run-in period, participants received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
|
LX9211 (Double-blind Treatment Period)
n=38 participants at risk
Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
|
Placebo (Single-blind Placebo Safety Follow-up Period)
n=38 participants at risk
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of matching placebo to LX9211 tablet, orally.
|
LX9211 (Single-blind Placebo Safety Follow-up Period)
n=31 participants at risk
Following completion of the 6-week double-blind Treatment Period, all participants entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of LX9211 tablet, orally.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/41 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
5.3%
2/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/31 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
10.5%
4/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/31 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
|
Gastrointestinal disorders
Diarrhea
|
7.3%
3/41 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/31 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/41 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
5.3%
2/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/31 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/41 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
7.9%
3/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
3.2%
1/31 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
|
Infections and infestations
Urinary tract infection
|
4.9%
2/41 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
7.9%
3/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
5.3%
2/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
3.2%
1/31 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/41 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
5.3%
2/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/31 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
|
Nervous system disorders
Dizziness
|
4.9%
2/41 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
28.9%
11/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/31 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
|
Nervous system disorders
Headache
|
4.9%
2/41 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
10.5%
4/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
2.6%
1/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
3.2%
1/31 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/41 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
5.3%
2/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/38 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
0.00%
0/31 • From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place