Trial Outcomes & Findings for Phase 2 Study of NV-5138 in Adults With Treatment Resistant Depression (NCT NCT05066672)
NCT ID: NCT05066672
Last Updated: 2026-04-17
Results Overview
MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes. A negative change from baseline indicates improvement in depressive symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
250 participants
Primary outcome timeframe
Baseline to Week 4
Results posted on
2026-04-17
Participant Flow
Participant milestones
| Measure |
NV-5138 (800 or 1600 mg)
Participants received either 800 or 1600 mg NV-5138 (2 or 4, 400 mg capsules) once daily for 4 weeks. After completion of the 4-week treatment, all participants received placebo in a double-blinded fashion and continued the treatment for one week.
During the first week of the Treatment Period, all participants took 1600 mg once a day. Participants who experienced an intolerable adverse effect at 1600 mg at Week 2, could have their dose reduced to 800 mg. Participants who had an inadequate response to 800 mg might have their dose increased again to 1600 mg per Investigator judgment to maximize their treatment response; however, no dose adjustments were allowed after Week 3.
|
Placebo
Participants received either 2 or 4 capsules of placebo once daily for 5 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
122
|
|
Overall Study
COMPLETED
|
104
|
104
|
|
Overall Study
NOT COMPLETED
|
22
|
18
|
Reasons for withdrawal
| Measure |
NV-5138 (800 or 1600 mg)
Participants received either 800 or 1600 mg NV-5138 (2 or 4, 400 mg capsules) once daily for 4 weeks. After completion of the 4-week treatment, all participants received placebo in a double-blinded fashion and continued the treatment for one week.
During the first week of the Treatment Period, all participants took 1600 mg once a day. Participants who experienced an intolerable adverse effect at 1600 mg at Week 2, could have their dose reduced to 800 mg. Participants who had an inadequate response to 800 mg might have their dose increased again to 1600 mg per Investigator judgment to maximize their treatment response; however, no dose adjustments were allowed after Week 3.
|
Placebo
Participants received either 2 or 4 capsules of placebo once daily for 5 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Noncompliance
|
7
|
4
|
|
Overall Study
Adverse Event
|
3
|
6
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Randomized in error, family emergency
|
2
|
1
|
Baseline Characteristics
HAM-D6 assessment was not required in Protocol version 1.0.
Baseline characteristics by cohort
| Measure |
NV-5138 (800 or 1600 mg)
n=126 Participants
Participants received either 800 or 1600 mg NV-5138 (2 or 4, 400 mg capsules) once daily for 4 weeks. After completion of the 4-week treatment, all participants received placebo in a double-blinded fashion and continued the treatment for one week.
During the first week of the Treatment Period, all participants took 1600 mg once a day. Participants who experienced an intolerable adverse effect at 1600 mg at Week 2, could have their dose reduced to 800 mg. Participants who had an inadequate response to 800 mg might have their dose increased again to 1600 mg per Investigator judgment to maximize their treatment response; however, no dose adjustments were allowed after Week 3.
|
Placebo
n=122 Participants
Participants received either 2 or 4 capsules of placebo once daily for 5 weeks.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
United States
|
126 Participants
n=126 Participants
|
122 Participants
n=122 Participants
|
248 Participants
n=248 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=126 Participants
|
1 Participants
n=122 Participants
|
2 Participants
n=248 Participants
|
|
Age, Continuous
|
48.2 years
STANDARD_DEVIATION 13.91 • n=126 Participants
|
48.7 years
STANDARD_DEVIATION 14.01 • n=122 Participants
|
48.4 years
STANDARD_DEVIATION 13.94 • n=248 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=126 Participants
|
86 Participants
n=122 Participants
|
162 Participants
n=248 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=126 Participants
|
36 Participants
n=122 Participants
|
86 Participants
n=248 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=126 Participants
|
32 Participants
n=122 Participants
|
63 Participants
n=248 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=126 Participants
|
90 Participants
n=122 Participants
|
183 Participants
n=248 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=126 Participants
|
0 Participants
n=122 Participants
|
2 Participants
n=248 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=126 Participants
|
0 Participants
n=122 Participants
|
2 Participants
n=248 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=126 Participants
|
4 Participants
n=122 Participants
|
5 Participants
n=248 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=126 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=248 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=126 Participants
|
18 Participants
n=122 Participants
|
35 Participants
n=248 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=126 Participants
|
99 Participants
n=122 Participants
|
204 Participants
n=248 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=126 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=248 Participants
|
|
MADRS Total Score
|
33.2 units on a scale
STANDARD_DEVIATION 5.04 • n=126 Participants
|
33.3 units on a scale
STANDARD_DEVIATION 4.65 • n=122 Participants
|
33.2 units on a scale
STANDARD_DEVIATION 4.84 • n=248 Participants
|
|
CGI-S
|
4.8 units on a scale
STANDARD_DEVIATION 0.63 • n=126 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 0.54 • n=122 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 0.59 • n=248 Participants
|
|
HAM-D6 Total Score
|
11.8 units on a scale
STANDARD_DEVIATION 2.15 • n=118 Participants • HAM-D6 assessment was not required in Protocol version 1.0.
|
12.0 units on a scale
STANDARD_DEVIATION 2.00 • n=113 Participants • HAM-D6 assessment was not required in Protocol version 1.0.
|
11.9 units on a scale
STANDARD_DEVIATION 2.08 • n=231 Participants • HAM-D6 assessment was not required in Protocol version 1.0.
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: Full Analysis Set (FAS) is a subset of participants in the randomized population who take at least one dose of study medication and have a baseline assessment of Montgomery-Asberg Depression Rating Scale (MADRS) total score.
MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes. A negative change from baseline indicates improvement in depressive symptoms.
Outcome measures
| Measure |
NV-5138 (800 or 1600 mg)
n=126 Participants
Participants received either 800 or 1600 mg NV-5138 (2 or 4 400 mg capsules) once daily for 4 weeks. After completion of the 4-week treatment, all participants received placebo in a double-blinded fashion and continued the treatment for one week.
During the first week of the Treatment Period, all participants took 1600 mg once a day. Participants who experienced an intolerable adverse effect at 1600 mg at Week 2, could have their dose reduced to 800 mg. Participants who had an inadequate response to 800 mg might have their dose increased again to 1600 mg per Investigator judgment to maximize their treatment response; however, no dose adjustments were allowed after Week 3.
|
Placebo
n=122 Participants
Participants received either 2 or 4 capsules of placebo once daily for 5 weeks.
|
|---|---|---|
|
Change From Baseline to Week 4 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.
|
-12.2 units on a scale
Standard Deviation 9.66
|
-11.6 units on a scale
Standard Deviation 10.64
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1, 2 and 3Population: Full Analysis Set (FAS) is a subset of participants in the randomized population who take at least one dose of study medication and have a baseline assessment of Montgomery-Asberg Depression Rating Scale (MADRS) total score.
MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes. A negative change from baseline indicates improvement in depressive symptoms.
Outcome measures
| Measure |
NV-5138 (800 or 1600 mg)
n=126 Participants
Participants received either 800 or 1600 mg NV-5138 (2 or 4 400 mg capsules) once daily for 4 weeks. After completion of the 4-week treatment, all participants received placebo in a double-blinded fashion and continued the treatment for one week.
During the first week of the Treatment Period, all participants took 1600 mg once a day. Participants who experienced an intolerable adverse effect at 1600 mg at Week 2, could have their dose reduced to 800 mg. Participants who had an inadequate response to 800 mg might have their dose increased again to 1600 mg per Investigator judgment to maximize their treatment response; however, no dose adjustments were allowed after Week 3.
|
Placebo
n=122 Participants
Participants received either 2 or 4 capsules of placebo once daily for 5 weeks.
|
|---|---|---|
|
Change From Baseline to Each Scheduled Week in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.
Week 3
|
-10.5 units on a scale
Standard Deviation 9.26
|
-10.3 units on a scale
Standard Deviation 9.19
|
|
Change From Baseline to Each Scheduled Week in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.
Week 1
|
-7.3 units on a scale
Standard Deviation 8.15
|
-5.8 units on a scale
Standard Deviation 6.48
|
|
Change From Baseline to Each Scheduled Week in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.
Week 2
|
-8.6 units on a scale
Standard Deviation 8.44
|
-8.9 units on a scale
Standard Deviation 8.35
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1, 2, 3 and 4Population: Full Analysis Set (FAS) is a subset of participants in the randomized population who take at least one dose of study medication and have a baseline assessment of Montgomery-Asberg Depression Rating Scale (MADRS) total score.
CGI-S is a single-item clinician rating of the clinician's assessment of the severity of symptoms in relation to the clinician's total experience with patients with that condition. The CGI-I is rated on a 7-point scale from 1 to 7, where 1 = "normal not at all ill" and 7 = "among the most extremely ill patients". Successful therapy is indicated by a lower overall score. A negative change from baseline indicates improvement in depressive symptoms.
Outcome measures
| Measure |
NV-5138 (800 or 1600 mg)
n=126 Participants
Participants received either 800 or 1600 mg NV-5138 (2 or 4 400 mg capsules) once daily for 4 weeks. After completion of the 4-week treatment, all participants received placebo in a double-blinded fashion and continued the treatment for one week.
During the first week of the Treatment Period, all participants took 1600 mg once a day. Participants who experienced an intolerable adverse effect at 1600 mg at Week 2, could have their dose reduced to 800 mg. Participants who had an inadequate response to 800 mg might have their dose increased again to 1600 mg per Investigator judgment to maximize their treatment response; however, no dose adjustments were allowed after Week 3.
|
Placebo
n=122 Participants
Participants received either 2 or 4 capsules of placebo once daily for 5 weeks.
|
|---|---|---|
|
Change From Baseline to Each Scheduled Week in the Clinical Global Impression - Severity of Illness Score (CGI-S).
Week 1
|
-0.7 units on a scale
Standard Deviation 1.02
|
-0.6 units on a scale
Standard Deviation 0.85
|
|
Change From Baseline to Each Scheduled Week in the Clinical Global Impression - Severity of Illness Score (CGI-S).
Week 2
|
-0.9 units on a scale
Standard Deviation 1.08
|
-0.9 units on a scale
Standard Deviation 1.07
|
|
Change From Baseline to Each Scheduled Week in the Clinical Global Impression - Severity of Illness Score (CGI-S).
Week 3
|
-1.2 units on a scale
Standard Deviation 1.18
|
-1.0 units on a scale
Standard Deviation 1.13
|
|
Change From Baseline to Each Scheduled Week in the Clinical Global Impression - Severity of Illness Score (CGI-S).
Week 4
|
-1.3 units on a scale
Standard Deviation 1.20
|
-1.2 units on a scale
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1, 2, 3 and 4Population: Full Analysis Set (FAS) is a subset of participants in the randomized population who take at least one dose of study medication and have a baseline assessment of Montgomery-Asberg Depression Rating Scale (MADRS) total score.
The Hamilton Depression Rating Scale - 6 Items is a diagnostic questionnaire used to measure the severity of depressive episodes. It consists of 6 items (depressed mood, work and activities, somatic symptoms general, feeling of guilt, anxiety psychic, retardation) and each question is scored from 0 to 4 except for one item, somatic symptoms general, which is scored from 0 - 2 for a total score ranging 0 to 22. Higher scores indicate more severe conditions. A negative change from baseline indicates improvement in depressive symptoms.
Outcome measures
| Measure |
NV-5138 (800 or 1600 mg)
n=126 Participants
Participants received either 800 or 1600 mg NV-5138 (2 or 4 400 mg capsules) once daily for 4 weeks. After completion of the 4-week treatment, all participants received placebo in a double-blinded fashion and continued the treatment for one week.
During the first week of the Treatment Period, all participants took 1600 mg once a day. Participants who experienced an intolerable adverse effect at 1600 mg at Week 2, could have their dose reduced to 800 mg. Participants who had an inadequate response to 800 mg might have their dose increased again to 1600 mg per Investigator judgment to maximize their treatment response; however, no dose adjustments were allowed after Week 3.
|
Placebo
n=122 Participants
Participants received either 2 or 4 capsules of placebo once daily for 5 weeks.
|
|---|---|---|
|
Change From Baseline to Each Scheduled Week in the The Hamilton Depression Rating Scale - 6 Items (HAM-D6) Total Score.
Week 1
|
-2.5 units on a scale
Standard Deviation 2.88
|
-2.0 units on a scale
Standard Deviation 2.75
|
|
Change From Baseline to Each Scheduled Week in the The Hamilton Depression Rating Scale - 6 Items (HAM-D6) Total Score.
Week 2
|
-3.0 units on a scale
Standard Deviation 3.33
|
-3.1 units on a scale
Standard Deviation 3.45
|
|
Change From Baseline to Each Scheduled Week in the The Hamilton Depression Rating Scale - 6 Items (HAM-D6) Total Score.
Week 3
|
-3.9 units on a scale
Standard Deviation 3.58
|
-3.9 units on a scale
Standard Deviation 3.69
|
|
Change From Baseline to Each Scheduled Week in the The Hamilton Depression Rating Scale - 6 Items (HAM-D6) Total Score.
Week 4
|
-4.3 units on a scale
Standard Deviation 3.62
|
-4.5 units on a scale
Standard Deviation 4.04
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1, 2, 3 and 4Population: The number of participants reported here is based on the Safety Population which includes all randomized participants who received at least one dose of study medication.
C-SSRS assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Number of participants with a response of 'yes' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported.
Outcome measures
| Measure |
NV-5138 (800 or 1600 mg)
n=126 Participants
Participants received either 800 or 1600 mg NV-5138 (2 or 4 400 mg capsules) once daily for 4 weeks. After completion of the 4-week treatment, all participants received placebo in a double-blinded fashion and continued the treatment for one week.
During the first week of the Treatment Period, all participants took 1600 mg once a day. Participants who experienced an intolerable adverse effect at 1600 mg at Week 2, could have their dose reduced to 800 mg. Participants who had an inadequate response to 800 mg might have their dose increased again to 1600 mg per Investigator judgment to maximize their treatment response; however, no dose adjustments were allowed after Week 3.
|
Placebo
n=122 Participants
Participants received either 2 or 4 capsules of placebo once daily for 5 weeks.
|
|---|---|---|
|
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline (Day 1) - Suicidal Behavior
|
0 participants
|
0 participants
|
|
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 1 - Suicidal Ideation
|
11 participants
|
7 participants
|
|
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 1 - Suicidal Behavior
|
0 participants
|
0 participants
|
|
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2 - Suicidal Ideation
|
9 participants
|
5 participants
|
|
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2 - Suicidal Behavior
|
0 participants
|
0 participants
|
|
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 3 - Suicidal Ideation
|
8 participants
|
6 participants
|
|
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 3 - Suicidal Behavior
|
0 participants
|
0 participants
|
|
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4 - Suicidal Ideation
|
8 participants
|
5 participants
|
|
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline (Day 1) - Suicidal Ideation
|
16 participants
|
13 participants
|
|
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4 - Suicidal Behavior
|
0 participants
|
0 participants
|
Adverse Events
NV-5138 (800 or 1600 mg)
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NV-5138 (800 or 1600 mg)
n=126 participants at risk
Participants received either 800 or 1600 mg NV-5138 (2 or 4, 400 mg capsules) once daily for 4 weeks. After completion of the 4-week treatment, all participants received placebo in a double-blinded fashion and continued the treatment for one week.
During the first week of the Treatment Period, all participants took 1600 mg once a day. Participants who experienced an intolerable adverse effect at 1600 mg at Week 2, could have their dose reduced to 800 mg. Participants who had an inadequate response to 800 mg might have their dose increased again to 1600 mg per Investigator judgment to maximize their treatment response; however, no dose adjustments were allowed after Week 3.
Only 8 participants received 800 mg of NV-5138 throughout the study so they were not analyzed separately.
|
Placebo
n=122 participants at risk
Participants received either 2 or 4 capsules of placebo once daily for 5 weeks.
|
|---|---|---|
|
Psychiatric disorders
Alcohol use disorder
|
0.00%
0/126 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
0.82%
1/122 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/126 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
0.82%
1/122 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.79%
1/126 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
0.00%
0/122 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/126 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
0.82%
1/122 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
Other adverse events
| Measure |
NV-5138 (800 or 1600 mg)
n=126 participants at risk
Participants received either 800 or 1600 mg NV-5138 (2 or 4, 400 mg capsules) once daily for 4 weeks. After completion of the 4-week treatment, all participants received placebo in a double-blinded fashion and continued the treatment for one week.
During the first week of the Treatment Period, all participants took 1600 mg once a day. Participants who experienced an intolerable adverse effect at 1600 mg at Week 2, could have their dose reduced to 800 mg. Participants who had an inadequate response to 800 mg might have their dose increased again to 1600 mg per Investigator judgment to maximize their treatment response; however, no dose adjustments were allowed after Week 3.
Only 8 participants received 800 mg of NV-5138 throughout the study so they were not analyzed separately.
|
Placebo
n=122 participants at risk
Participants received either 2 or 4 capsules of placebo once daily for 5 weeks.
|
|---|---|---|
|
Nervous system disorders
Headache
|
4.8%
6/126 • Number of events 8 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
10.7%
13/122 • Number of events 13 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
|
Nervous system disorders
Dizziness
|
7.9%
10/126 • Number of events 14 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
4.9%
6/122 • Number of events 6 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
14/126 • Number of events 14 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
9.0%
11/122 • Number of events 11 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
4/126 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
5.7%
7/122 • Number of events 7 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication (Day 1) up to 9 weeks (i.e., 5 weeks treatment period and safety follow up phone call 30 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place