Trial Outcomes & Findings for Randomized Trial of Adult Participants With Generalized Anxiety Disorder (NCT NCT03829241)
NCT ID: NCT03829241
Last Updated: 2024-05-08
Results Overview
The HAM-A was an investigator-administered scale and consisted of 14 items: anxious mood, tension, fears, insomnia, concentration, depressed mood, behavior at interview, somatic muscular, somatic sensory, cardiovascular, respiratory, gastrointestinal, genitourinary, and autonomic symptoms. Each item was scored on a scale of 0 (not present) to 4 (severe) with a total score range of 0-56. A decreased score indicated a decrease in anxiety symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
881 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2024-05-08
Participant Flow
The study was conducted at 53 sites in the United States.
A total of 881 participants were enrolled, of which 402 participants were randomized in a 1:1: ratio to receive troriluzole or placebo. 479 participants were not randomized due to withdrawal of concent, lost to follow-up, failed inclusion/exclusion criteria, or other reasons.
Participant milestones
| Measure |
Troriluzole
Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules twice daily (BID) orally for up to 8 weeks in the double-blind (DB) randomization phase.
Extension phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed open-label (OL) treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks.
|
Placebo
Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase.
Extension Phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed OL treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks.
|
|---|---|---|
|
Randomization Phase (Week 1 to Week 8)
STARTED
|
202
|
200
|
|
Randomization Phase (Week 1 to Week 8)
Treated
|
199
|
191
|
|
Randomization Phase (Week 1 to Week 8)
Modified Intent-to- Treat (mITT) Participants
|
198
|
187
|
|
Randomization Phase (Week 1 to Week 8)
COMPLETED
|
171
|
158
|
|
Randomization Phase (Week 1 to Week 8)
NOT COMPLETED
|
31
|
42
|
|
Extension Phase (Week 9 up to Week 48)
STARTED
|
159
|
154
|
|
Extension Phase (Week 9 up to Week 48)
Treated
|
153
|
149
|
|
Extension Phase (Week 9 up to Week 48)
COMPLETED
|
0
|
0
|
|
Extension Phase (Week 9 up to Week 48)
NOT COMPLETED
|
159
|
154
|
Reasons for withdrawal
| Measure |
Troriluzole
Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules twice daily (BID) orally for up to 8 weeks in the double-blind (DB) randomization phase.
Extension phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed open-label (OL) treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks.
|
Placebo
Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase.
Extension Phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed OL treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks.
|
|---|---|---|
|
Randomization Phase (Week 1 to Week 8)
Withdrawal of Consent
|
16
|
19
|
|
Randomization Phase (Week 1 to Week 8)
Lost to Follow-up
|
5
|
11
|
|
Randomization Phase (Week 1 to Week 8)
Sponsor Request
|
0
|
1
|
|
Randomization Phase (Week 1 to Week 8)
Adverse Event
|
8
|
9
|
|
Randomization Phase (Week 1 to Week 8)
Non compliance
|
2
|
1
|
|
Randomization Phase (Week 1 to Week 8)
Pregnancy
|
0
|
1
|
|
Extension Phase (Week 9 up to Week 48)
Withdrawal of Consent
|
20
|
24
|
|
Extension Phase (Week 9 up to Week 48)
Lost to Follow-up
|
9
|
7
|
|
Extension Phase (Week 9 up to Week 48)
Physician Decision
|
1
|
0
|
|
Extension Phase (Week 9 up to Week 48)
Sponsor Request
|
117
|
108
|
|
Extension Phase (Week 9 up to Week 48)
Significant Protocol Violation
|
0
|
1
|
|
Extension Phase (Week 9 up to Week 48)
Adverse Event
|
11
|
11
|
|
Extension Phase (Week 9 up to Week 48)
Non compliance
|
1
|
1
|
|
Extension Phase (Week 9 up to Week 48)
Pregnancy
|
0
|
2
|
Baseline Characteristics
Randomized Trial of Adult Participants With Generalized Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Troriluzole
n=199 Participants
Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules BID orally for up to 8 weeks in the DB randomization phase.
Extension phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed OL treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks.
|
Placebo
n=191 Participants
Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase.
Extension Phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed OL treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks.
|
Total
n=390 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.4 years
STANDARD_DEVIATION 12.72 • n=93 Participants
|
37.5 years
STANDARD_DEVIATION 12.59 • n=4 Participants
|
38.0 years
STANDARD_DEVIATION 12.65 • n=27 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=93 Participants
|
147 Participants
n=4 Participants
|
299 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
170 Participants
n=93 Participants
|
155 Participants
n=4 Participants
|
325 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
151 Participants
n=93 Participants
|
151 Participants
n=4 Participants
|
302 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Hamilton Anxiety Rating Scale (HAM-A): Total score
|
24.7 score on a scale
STANDARD_DEVIATION 4.34 • n=93 Participants
|
24.1 score on a scale
STANDARD_DEVIATION 3.80 • n=4 Participants
|
24.4 score on a scale
STANDARD_DEVIATION 4.08 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: The mITT participants in the randomization phase (randomized participants who received at least 1 dose of blinded study therapy \[troriluzole or placebo\], and provided a non-missing baseline assessment and at least 1 non-missing post-baseline efficacy assessment during the randomization phase) were analyzed.
The HAM-A was an investigator-administered scale and consisted of 14 items: anxious mood, tension, fears, insomnia, concentration, depressed mood, behavior at interview, somatic muscular, somatic sensory, cardiovascular, respiratory, gastrointestinal, genitourinary, and autonomic symptoms. Each item was scored on a scale of 0 (not present) to 4 (severe) with a total score range of 0-56. A decreased score indicated a decrease in anxiety symptoms.
Outcome measures
| Measure |
Troriluzole
n=198 Participants
Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules BID orally for up to 8 weeks in the DB randomization phase.
|
Placebo
n=187 Participants
Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase.
|
|---|---|---|
|
Change From Baseline in the HAM-A Total Score at Week 8
|
-9.28 score on a scale
Interval -10.23 to -8.32
|
-9.35 score on a scale
Interval -10.34 to -8.36
|
SECONDARY outcome
Timeframe: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks)Population: Treated participants in the randomization phase: Enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
A serious adverse event (SAE) was defined as any event that met any of the following criteria: 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 rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. Treatment-emergent AEs (TEAEs) in the randomization phase included any adverse event (AE) with an onset date on or after the first day of double-blind study drug and up to the first day of open-label study drug in the extension phase (for participants entering the extension phase) or last day of the randomization phase study drug + 30 days.
Outcome measures
| Measure |
Troriluzole
n=199 Participants
Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules BID orally for up to 8 weeks in the DB randomization phase.
|
Placebo
n=191 Participants
Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase.
|
|---|---|---|
|
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Medication During Randomized Phase
Participants with at least 1 serious TEAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Medication During Randomized Phase
Participants with at least 1 TEAE related to study medication
|
59 Participants
|
47 Participants
|
|
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Medication During Randomized Phase
Participants with at least 1 TEAE leading to withdrawal from study drug
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)Population: Treated participants in the extension phase: Treated participants in the randomization phase who received at least 1 dose of troriluzole in the open-label (OL) extension phase.
An SAE was defined as any event that met any of the following criteria: 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 rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. TEAEs in the extension phase included any AE with an onset date on or after the first day of the study drug in the extension phase and up to the last day of the study drug in the extension phase + 30 days.
Outcome measures
| Measure |
Troriluzole
n=153 Participants
Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules BID orally for up to 8 weeks in the DB randomization phase.
|
Placebo
n=149 Participants
Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase.
|
|---|---|---|
|
Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase
Participants with at least 1 serious TEAE
|
3 Participants
|
1 Participants
|
|
Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase
Participants with at least 1 TEAE related to study medication
|
29 Participants
|
27 Participants
|
|
Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase
Participants with at least 1 TEAE leading to withdrawal from study drug
|
9 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks)Population: Treated participants in the randomization phase with available data were analyzed.
Clinically significant laboratory abnormalities were defined as Grade 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0 (2017) or the Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017), where Grade 3=Severe and Grade 4=Potentially Life Threatening. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis.
Outcome measures
| Measure |
Troriluzole
n=194 Participants
Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules BID orally for up to 8 weeks in the DB randomization phase.
|
Placebo
n=178 Participants
Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase.
|
|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Urine Glucose
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Hemoglobin
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Leukocytes
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Lymphocytes, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Lymphocytes, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Neutrophils
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Platelets
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Alanine Aminotransferase
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Albumin
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Alkaline Phosphatase
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Aspartate Aminotransferase
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Bicarbonate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Bilirubin
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Calcium, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Calcium, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Creatine Kinase
|
3 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Creatinine
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Glucose, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Glucose, high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Lactate Dehydrogenase
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Potassium, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Potassium, high
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Sodium, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Sodium, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Urate
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase
Urine Protein
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: 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 (SDS total score) that ranged from 0 (unimpaired) to 30 (highly impaired).
Outcome measures
| Measure |
Troriluzole
n=177 Participants
Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules BID orally for up to 8 weeks in the DB randomization phase.
|
Placebo
n=174 Participants
Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase.
|
|---|---|---|
|
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
|
-5.78 score on a scale
Interval -6.84 to -4.72
|
-5.53 score on a scale
Interval -6.6 to -4.47
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: The mITT participants in the randomization phase were analyzed.
Participants rated on the seven-point severity of Illness with severity of wherein 1 = normal, not at all; 2= borderline ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7 = among the most extremely ill participants.
Outcome measures
| Measure |
Troriluzole
n=198 Participants
Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules BID orally for up to 8 weeks in the DB randomization phase.
|
Placebo
n=187 Participants
Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase.
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score at Week 8
|
-1.19 score on a scale
Interval -1.35 to -1.03
|
-1.21 score on a scale
Interval -1.38 to -1.04
|
Adverse Events
Troriluzole - Randomization Phase
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo - Randomization Phase
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Troriluzole - Randomization Phase/Troriluzole - Extension Phase
Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo - Randomization Phase/Troriluzole - Extension Phase
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Troriluzole - Randomization Phase
n=199 participants at risk
Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules BID orally for up to 8 weeks in the DB randomization phase.
|
Placebo - Randomization Phase
n=191 participants at risk
Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase.
|
Troriluzole - Randomization Phase/Troriluzole - Extension Phase
n=153 participants at risk
Extension phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed open-label (OL) treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks.
|
Placebo - Randomization Phase/Troriluzole - Extension Phase
n=149 participants at risk
Extension Phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed OL treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Myocarditis
|
0.00%
0/199 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
0.00%
0/191 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
0.00%
0/153 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
0.67%
1/149 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/199 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
0.00%
0/191 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
0.65%
1/153 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
0.00%
0/149 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/199 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
0.00%
0/191 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
0.65%
1/153 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
0.00%
0/149 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.00%
0/199 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
0.00%
0/191 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
0.65%
1/153 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
0.00%
0/149 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
Other adverse events
| Measure |
Troriluzole - Randomization Phase
n=199 participants at risk
Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules BID orally for up to 8 weeks in the DB randomization phase.
|
Placebo - Randomization Phase
n=191 participants at risk
Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase.
|
Troriluzole - Randomization Phase/Troriluzole - Extension Phase
n=153 participants at risk
Extension phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed open-label (OL) treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks.
|
Placebo - Randomization Phase/Troriluzole - Extension Phase
n=149 participants at risk
Extension Phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed OL treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.5%
17/199 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
8.4%
16/191 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
2.0%
3/153 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
2.0%
3/149 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
|
Nervous system disorders
Headache
|
4.0%
8/199 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
6.3%
12/191 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
4.6%
7/153 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
1.3%
2/149 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
|
General disorders
Fatigue
|
5.0%
10/199 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
4.7%
9/191 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
2.0%
3/153 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
2.7%
4/149 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
10/199 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
2.1%
4/191 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
5.2%
8/153 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
8.7%
13/149 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
5/199 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
2.6%
5/191 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
6.5%
10/153 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
6.7%
10/149 • Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60