Trial Outcomes & Findings for Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder (NCT NCT03299166)
NCT ID: NCT03299166
Last Updated: 2026-01-22
Results Overview
The Y-BOCS is a clinician-administered scale used extensively in research and clinical practice to both rate severity of obsessive compulsive disorder (OCD) and to monitor improvement during treatment. It is designed to rate the severity of obsessions and compulsions as well as the type of symptoms in patients with OCD. The scale consists of 10 items; the first 5 items assess obsessions, and the last 5 items assess compulsions. Subscale scores can be calculated for obsessions and compulsions, each on a scale of 0 to 20. A total score ranging from 0 to 40 can then be correlated to overall severity. The higher the number on the Y-BOCS, the more severe the symptoms.
COMPLETED
PHASE2/PHASE3
426 participants
Baseline, Week 12
2026-01-22
Participant Flow
The study was conducted at 56 sites in the United States.
A total of 426 participants were enrolled, of which 248 participants were randomized in a 1:1: ratio to receive troriluzole (BHV-4157) or placebo. A total of 178 participants were not randomized due to withdrawal of consent, lost to follow-up, failed inclusion/exclusion criteria, or other reasons.
Participant milestones
| Measure |
Troriluzole - Randomization Phase
Randomization phase (Weeks 1 through 12): Participants received troriluzole 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks in the double-blind (DB) randomization phase.
|
Placebo - Randomization Phase
Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
124
|
|
Overall Study
Treated
|
122
|
122
|
|
Overall Study
Modified Intent-to- Treat (mITT) Participants
|
115
|
117
|
|
Overall Study
COMPLETED
|
101
|
109
|
|
Overall Study
NOT COMPLETED
|
23
|
15
|
Reasons for withdrawal
| Measure |
Troriluzole - Randomization Phase
Randomization phase (Weeks 1 through 12): Participants received troriluzole 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks in the double-blind (DB) randomization phase.
|
Placebo - Randomization Phase
Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Sponsor Decision
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Randomization Error
|
0
|
1
|
|
Overall Study
Subject unable to return due to COVID
|
1
|
0
|
|
Overall Study
Unable to complete Week 12 visit at site
|
1
|
0
|
Baseline Characteristics
Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder
Baseline characteristics by cohort
| Measure |
Troriluzole - Randomization Phase
n=122 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks in the double-blind (DB) randomization phase.
|
Placebo - Randomization Phase
n=122 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase.
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.9 Years
STANDARD_DEVIATION 13.09 • n=270 Participants
|
35.5 Years
STANDARD_DEVIATION 13.26 • n=4 Participants
|
36.7 Years
STANDARD_DEVIATION 13.20 • n=9 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=270 Participants
|
74 Participants
n=4 Participants
|
149 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=270 Participants
|
48 Participants
n=4 Participants
|
95 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=270 Participants
|
17 Participants
n=4 Participants
|
27 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=270 Participants
|
105 Participants
n=4 Participants
|
217 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=270 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=270 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=270 Participants
|
103 Participants
n=4 Participants
|
203 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Total Y-BOCS score at Randomization
|
25.9 Units on a scale
STANDARD_DEVIATION 3.91 • n=270 Participants
|
26.0 Units on a scale
STANDARD_DEVIATION 4.32 • n=4 Participants
|
26.0 Units on a scale
STANDARD_DEVIATION 4.11 • n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: mITT: Randomized participants who received at least 1 dose of study therapy and provided a non-missing baseline assessment and at least 1 non-missing post-baseline efficacy assessment in the randomization phase.
The Y-BOCS is a clinician-administered scale used extensively in research and clinical practice to both rate severity of obsessive compulsive disorder (OCD) and to monitor improvement during treatment. It is designed to rate the severity of obsessions and compulsions as well as the type of symptoms in patients with OCD. The scale consists of 10 items; the first 5 items assess obsessions, and the last 5 items assess compulsions. Subscale scores can be calculated for obsessions and compulsions, each on a scale of 0 to 20. A total score ranging from 0 to 40 can then be correlated to overall severity. The higher the number on the Y-BOCS, the more severe the symptoms.
Outcome measures
| Measure |
Troriluzole - Randomization Phase
n=115 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks in the double-blind (DB) randomization phase.
|
Placebo - Randomization Phase
n=117 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase.
|
|---|---|---|
|
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score
|
-5.91 Scores on a scale
Interval -7.05 to -4.77
|
-4.91 Scores on a scale
Interval -6.03 to -3.79
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Treated participants in the randomization phase
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, been life-threatening, or required hospitalization, or, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent other serious outcomes.
Outcome measures
| Measure |
Troriluzole - Randomization Phase
n=122 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks in the double-blind (DB) randomization phase.
|
Placebo - Randomization Phase
n=122 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase
Participants with at least 1 AE
|
61 participants
|
61 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase
Participants with at least 1 SAE
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase
Participants with at least 1 AEs Leading to Study Drug Discontinuation
|
13 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Up to 192 weeksAn AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, been life-threatening, or required hospitalization, or, based upon appropriate medical judgment may, have jeopardized the participant and may have required medical or surgical intervention to prevent other serious outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Treated participants in the randomization phase
Clinically significant laboratory abnormalities were defined as Grade 3 or 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017). Laboratory tests of clinical interest for troriluzole included absolute neutrophil count \< 500 per mm\^3, alanine aminotransferase or aspartate aminotransferase \> 3x upper limit of normal (ULN), and total bilirubin ≥ 2x ULN (Laboratory results were presented in US units).
Outcome measures
| Measure |
Troriluzole - Randomization Phase
n=122 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks in the double-blind (DB) randomization phase.
|
Placebo - Randomization Phase
n=122 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase.
|
|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Hemoglobin, serum
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Lymphocytes, low
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Lymphocytes, high
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Neutrophils
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Platelets
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
White blood cells
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Alanine Aminotransferase
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Albumin
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Alkaline Phosphatase
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Aspartate Aminotransferase
|
2 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Bicarbonate
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Bilirubin
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Calcium, low
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Calcium, high
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Creatine Kinase
|
6 participants
|
2 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Creatinine
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Glucose, Serum, low
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Glucose, Serum, high
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Lactate Dehydrogenase
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Potassium, low
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Potassium, high
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Sodium, low
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Sodium, high
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Urate
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Glucose, Urine
|
1 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Protein, Urine
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The mITT participants in the randomization phase with available data were analyzed
The SDS was assessed in 3 domains: work/school (0-10), social life (0-10), and family life (0-10). The score from each domain was summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). If the participant has not worked or studied for reasons unrelated to OCD, then the total score was considered as missing.
Outcome measures
| Measure |
Troriluzole - Randomization Phase
n=102 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks in the double-blind (DB) randomization phase.
|
Placebo - Randomization Phase
n=105 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase.
|
|---|---|---|
|
Change From Baseline in Functional Disability Assessed Using the Sheehan Disability Scale (SDS) Total Score
|
-4.68 Scores on a scale
Interval -6.01 to -3.36
|
-3.68 Scores on a scale
Interval -4.96 to -2.39
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT participants
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Troriluzole - Randomization Phase
n=115 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks in the double-blind (DB) randomization phase.
|
Placebo - Randomization Phase
n=117 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase.
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score
|
-0.67 Scores on a scale
Interval -0.84 to -0.5
|
-0.59 Scores on a scale
Interval -0.76 to -0.42
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT participants
The Y-BOCS Obsessions Sub-scale consists of the last 5 items on the Y-BOCS and is measured on a scale of 0 to 20. A higher score on the Y-BOCS corresponds to greater symptom severity.
Outcome measures
| Measure |
Troriluzole - Randomization Phase
n=115 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks in the double-blind (DB) randomization phase.
|
Placebo - Randomization Phase
n=117 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase.
|
|---|---|---|
|
Change From Baseline in the Y-BOCS Obsessions Sub-Scale Score
|
-2.91 Scores on a scale
Interval -3.53 to -2.28
|
-2.55 Scores on a scale
Interval -3.16 to -1.93
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and Week 8Population: mITT participants
The Y-BOCS is a clinician-administered scale used extensively in research and clinical practice to both rate severity of obsessive compulsive disorder (OCD) and to monitor improvement during treatment. It is designed to rate the severity of obsessions and compulsions as well as the type of symptoms in patients with OCD. The scale consists of 10 items; the first 5 items assess obsessions, and the last 5 items assess compulsions. Subscale scores can be calculated for obsessions and compulsions, each on a scale of 0 to 20. A total score ranging from 0 to 40 can then be correlated to overall severity. The higher the number on the Y-BOCS, the more severe the symptoms.
Outcome measures
| Measure |
Troriluzole - Randomization Phase
n=115 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks in the double-blind (DB) randomization phase.
|
Placebo - Randomization Phase
n=117 Participants
Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase.
|
|---|---|---|
|
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score at Weeks 4 and 8
Week 4
|
-3.40 Scores on a scale
Interval -4.26 to -2.53
|
-2.93 Scores on a scale
Interval -3.78 to -2.08
|
|
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score at Weeks 4 and 8
Week 8
|
-5.10 Scores on a scale
Interval -6.16 to -4.04
|
-3.56 Scores on a scale
Interval -4.59 to -2.53
|
Adverse Events
Troriluzole - Randomization Phase
Placebo - Randomization Phase
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Troriluzole - Randomization Phase
n=122 participants at risk
Randomization phase (Weeks 1 through 12): Participants received troriluzole 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks in the double-blind (DB) randomization phase.
|
Placebo - Randomization Phase
n=122 participants at risk
Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase.
|
|---|---|---|
|
Nervous system disorders
Headache
|
8.2%
10/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
6.6%
8/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
|
Nervous system disorders
Dizziness
|
7.4%
9/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
1.6%
2/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
|
Nervous system disorders
Somnolence
|
6.6%
8/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
1.6%
2/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.82%
1/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
7.4%
9/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
|
Gastrointestinal disorders
Nausea
|
6.6%
8/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
1.6%
2/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
|
General disorders
Fatigue
|
7.4%
9/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
4.1%
5/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
7/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
0.82%
1/122 • Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60