Trial · NCT02960893
Trial in Adult Participants With Spinocerebellar Ataxia (SCA)
NCT02960893, Phase 2, Phase 3, Completed, Biohaven Pharmaceuticals, Inc.; results first posted 2020-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial in Adult Participants With Spinocerebellar Ataxia (SCA). Trials, record NCT02960893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02960893
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial in Adult Participants With Spinocerebellar Ataxia (SCA)
- NCT number
- NCT02960893
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 141 participants, actual
- Lead sponsor
- Biohaven Pharmaceuticals, Inc.
- Conditions
Spinocerebellar Ataxias, Spinocerebellar Ataxia Genotype Type 1, Spinocerebellar Ataxia Genotype Type 2, Spinocerebellar Ataxia Genotype Type 3, Spinocerebellar Ataxia Genotype Type 6, Spinocerebellar Ataxia Genotype Type 7, Spinocerebellar Ataxia Genotype Type 8, Spinocerebellar Ataxia Genotype Type 10
- Interventions
- Troriluzole, Placebo, Troriluzole
- First posted
- 2016-11-10
- Last updated
- 2025-10-08
- Results first posted
- 2020-08-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Score on the Scale for the Assessment and Rating of Ataxia (SARA) at Randomization Phase Week 8 | Baseline, Randomization Phase Week 8 | The severity of ataxia was assessed with the SARA, an 8-item clinical rating scale from 0 (no ataxia) to 40 (most severe ataxia). The total score was derived as the sum of the individual items, which included gait (0-8), stance (0-6), sitting (0-4), speech disturbance (0-6), finger chase (0-4), nose-finger test (0-4), fast alternating hand movements (0-4), and heel-shin slide (0-4). Since the finger chase, nose-finger test, fast alternating hand movements, and heel-shin slide were repeated on both the right and left side, the average of the right and left side assessments was used to derive the total score. A negative change in score shows improvement. |
| Secondary | Number of Participants With Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-Emergent AEs (TEAEs) During the Randomization Phase | From first dose of study drug to 30 days post the last dose in the Randomization Phase (Up to 12 weeks) | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition, unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. An SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or suspected transmission of an infectious agent, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. TEAEs were defined as those AEs that developed, worsened, or became serious after the first dose of study drug. |
| Secondary | Number of Participants With Deaths, SAEs, AEs Leading to Discontinuation and TEAEs During the OLE Phase | From first dose of study drug to 30 days post the last dose in the OLE Phase (Up to 340 weeks) | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition, unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. An SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or suspected transmission of an infectious agent, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. TEAEs were defined as those AEs that developed, worsened, or became serious after the first dose of study drug. |
| Secondary | Number of Participants Who Received At Least One Dose of Troriluzole in the Randomization Phase or OLE Phase With Deaths, SAEs, AEs Leading to Discontinuation and TEAEs | From first dose of study drug to 30 days post the last dose in the OLE Phase (Up to 348 weeks after last randomization participant was enrolled) | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition, unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. An SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or suspected transmission of an infectious agent, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. TEAEs were defined as those AEs that developed, worsened, or became serious after the first dose of study drug. |
| Secondary | Number of Participants With Impression of Benefit Via Use of the Patient Global Impression of Change (PGI-C) Index Scale During Randomization Phase | Randomization Phase Week 8 | PGI-C is a patient self-reported global index scale that was used to rate the response of a condition to therapy. Participants rated their impression of benefit based on the following 7 categories: No change (or condition has gotten worse); Almost the same, hardly any change at all; A little better, but no noticeable change; Somewhat better, but the change has not made any real difference; Moderately better, and a slight but noticeable change; Better and a definitive improvement that has made a real and worthwhile difference; A great deal better and a considerable improvement that has made all the difference. |
| Other | Change From Randomization Baseline in Total Score on the SARA at Extension Phase Week 48 | Randomization Baseline, Extension Phase Week 48 | The severity of ataxia was assessed with the SARA, an 8-item clinical rating scale from 0 (no ataxia) to 40 (most severe ataxia). The total score was derived as the sum of the individual items, which included gait (0-8), stance (0-6), sitting (0-4), speech disturbance (0-6), finger chase (0-4), nose-finger test (0-4), fast alternating hand movements (0-4), and heel-shin slide (0-4). Since the finger chase, nose-finger test, fast alternating hand movements, and heel-shin slide were repeated on both the right and left side, the average of the right and left side assessments was used to derive the total score. A negative change in score shows improvement. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Score on the Scale for the Assessment and Rating of Ataxia (SARA) at Randomization Phase Week 8 | Baseline, Randomization Phase Week 8 | Full Analysis Set (FAS): All randomized participants with at least one dose of study drug and a baseline and post-baseline Total SARA score during the Randomization Phase. Here, number of participants analyzed signifies the number of evaluable participants with change from baseline in Total SARA score at Week 8. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-Emergent AEs (TEAEs) During the Randomization Phase | From first dose of study drug to 30 days post the last dose in the Randomization Phase (Up to 12 weeks) | Safety Analysis Set (Randomization Phase): All participants who received at least one dose of study drug during the Randomization Phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Deaths, SAEs, AEs Leading to Discontinuation and TEAEs During the OLE Phase | From first dose of study drug to 30 days post the last dose in the OLE Phase (Up to 340 weeks) | Safety Analysis Set (OLE Phase): All participants who received at least one dose of study drug during the OLE Phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Received At Least One Dose of Troriluzole in the Randomization Phase or OLE Phase With Deaths, SAEs, AEs Leading to Discontinuation and TEAEs | From first dose of study drug to 30 days post the last dose in the OLE Phase (Up to 348 weeks after last randomization participant was enrolled) | All participants who received at least one dose of Troriluzole during the Randomization Phase or OLE Phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Impression of Benefit Via Use of the Patient Global Impression of Change (PGI-C) Index Scale During Randomization Phase | Randomization Phase Week 8 | Full Analysis Set (FAS): All randomized participants with at least one dose of study drug and a baseline and post-baseline Total SARA score during the Randomization Phase. Here, number of participants analyzed signifies the number of evaluable participants for PGI-C index at Week 8. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Randomization Baseline in Total Score on the SARA at Extension Phase Week 48 | Randomization Baseline, Extension Phase Week 48 | Full Analysis Set (FAS): All randomized participants with at least one dose of study drug and a baseline and post-baseline Total SARA score during the Randomization Phase. Here, number of participants analyzed signifies the number of evaluable participants with change from Randomization baseline in Total SARA score at Week 48. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Total Score on the Scale for the Assessment and Rating of Ataxia (SARA) at Randomization Phase Week 8 | Troriluzole - Randomization Phase | -0.810 | Standard Deviation 1.7653 | score on a scale | |
| Change From Baseline in Total Score on the Scale for the Assessment and Rating of Ataxia (SARA) at Randomization Phase Week 8 | Placebo - Randomization Phase | -1.059 | Standard Deviation 2.3221 | score on a scale | |
| Number of Participants With Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-Emergent AEs (TEAEs) During the Randomization Phase | Troriluzole - Randomization Phase | Deaths | 0 | Participants | |
| Number of Participants With Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-Emergent AEs (TEAEs) During the Randomization Phase | Placebo - Randomization Phase | Deaths | 0 | Participants | |
| Number of Participants With Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-Emergent AEs (TEAEs) During the Randomization Phase | Troriluzole - Randomization Phase | SAEs | 4 | Participants | |
| Number of Participants With Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-Emergent AEs (TEAEs) During the Randomization Phase | Placebo - Randomization Phase | SAEs | 1 | Participants | |
| Number of Participants With Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-Emergent AEs (TEAEs) During the Randomization Phase | Troriluzole - Randomization Phase | Discontinued due to AEs | 3 | Participants | |
| Number of Participants With Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-Emergent AEs (TEAEs) During the Randomization Phase | Placebo - Randomization Phase | Discontinued due to AEs | 0 | Participants | |
| Number of Participants With Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-Emergent AEs (TEAEs) During the Randomization Phase | Troriluzole - Randomization Phase | TEAEs | 40 | Participants | |
| Number of Participants With Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-Emergent AEs (TEAEs) During the Randomization Phase | Placebo - Randomization Phase | TEAEs | 35 | Participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization Phase (8 Weeks) | STARTED | Troriluzole - Randomization Phase | 71 | |
| Randomization Phase (8 Weeks) | STARTED | Placebo - Randomization Phase | 70 | |
| Randomization Phase (8 Weeks) | STARTED | Troriluzole/Troriluzole - Open Label Extension (OLE) Phase | 0 | |
| Randomization Phase (8 Weeks) | STARTED | Placebo/Troriluzole - OLE Phase | 0 | |
| Randomization Phase (8 Weeks) | COMPLETED | Troriluzole - Randomization Phase | 64 | |
| Randomization Phase (8 Weeks) | COMPLETED | Placebo - Randomization Phase | 68 | |
| Randomization Phase (8 Weeks) | COMPLETED | Troriluzole/Troriluzole - Open Label Extension (OLE) Phase | 0 | |
| Randomization Phase (8 Weeks) | COMPLETED | Placebo/Troriluzole - OLE Phase | 0 | |
| Randomization Phase (8 Weeks) | NOT COMPLETED | Troriluzole - Randomization Phase | 7 | |
| Randomization Phase (8 Weeks) | NOT COMPLETED | Placebo - Randomization Phase | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events284
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Troriluzole - Randomization Phase | 4 | 71 | |
| other | Nausea | Gastrointestinal disorders | Placebo - Randomization Phase | 4 | 70 | |
| other | Nausea | Gastrointestinal disorders | Troriluzole/Troriluzole - OLE Phase | 9 | 64 | |
| other | Nausea | Gastrointestinal disorders | Placebo/Troriluzole - OLE Phase | 7 | 67 | |
| other | Fatigue | General disorders | Troriluzole - Randomization Phase | 6 | 71 | |
| other | Fatigue | General disorders | Placebo - Randomization Phase | 3 | 70 | |
| other | Fatigue | General disorders | Troriluzole/Troriluzole - OLE Phase | 8 | 64 | |
| other | Fatigue | General disorders | Placebo/Troriluzole - OLE Phase | 10 | 67 | |
| other | Fall | Injury, poisoning and procedural complications | Troriluzole - Randomization Phase | 6 | 71 | |
| other | Fall | Injury, poisoning and procedural complications | Placebo - Randomization Phase | 2 | 70 |
1 to 10 of 284Source ClinicalTrials.gov
See all 284 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Troriluzole - Randomization Phase | 0 | 71 |
| Total, all-cause mortality | Placebo - Randomization Phase | 0 | 70 |
| Total, all-cause mortality | Troriluzole/Troriluzole - OLE Phase | 2 | 64 |
| Total, all-cause mortality | Placebo/Troriluzole - OLE Phase | 1 | 67 |
| Total, other adverse events | Troriluzole - Randomization Phase | 22 | 71 |
| Total, other adverse events | Placebo - Randomization Phase | 18 | 70 |
| Total, other adverse events | Troriluzole/Troriluzole - OLE Phase | 48 | 64 |
| Total, other adverse events | Placebo/Troriluzole - OLE Phase | 50 | 67 |
| Total, serious adverse events | Troriluzole - Randomization Phase | 4 | 71 |
| Total, serious adverse events | Placebo - Randomization Phase | 1 | 70 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34115419 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02960893
GET https://conductscience.org/api/trials/v1/NCT02960893/results?page=2