A Phase 3 interventional study of troriluzole and Placebo in Spinocerebellar Ataxias, Spinocerebellar Ataxia Type 1 and Spinocerebellar Ataxia Type 2, sponsored by Biohaven Pharmaceuticals, Inc.. Active, not recruiting at 23 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Biohaven Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the efficacy of Troriluzole (200 mg once daily) versus placebo after 48 weeks of treatment in subjects with spinocerebellar ataxia (SCA).
33 studies on the registry are indexed under Machado-Joseph Disease; 5 are open to participants now.
This study's enrollment of 299 is above the median of 23 across 21 interventional studies indexed under Machado-Joseph Disease.
Browse Machado-Joseph Disease studies →Biohaven Pharmaceuticals, Inc. is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 6 (60%) have results posted.
Compared within Machado-Joseph Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Spinocerebellar Ataxias. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with a known or suspected diagnosis of the following specific hereditary ataxias: SCA1, SCA2, SCA3, SCA6, SCA7, SCA8 and SCA10.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Randomization phase (Randomization through Week 48): Participants received starting dose of troriluzole 140 milligrams (mg) capsules orally once daily for first 4 weeks, followed by 200 mg once daily for the remaining 44 weeks of 48-week duration of the double-blind randomization phase. Open-label extension (OLE) phase (OLE Week 1 up to Week 192): Participants who were eligible and agreed to enroll in an OLE phase, will receive troriluzole 200 mg capsules orally once daily for 4 weeks in a blinded manner. After OLE Week 4, all participants will then receive open label troriluzole 200 mg up to Week 192.
Drug: troriluzole
Randomization phase (Randomization through Week 48): Participants received troriluzole matching placebo capsules orally once daily for 48 weeks duration of the double-blind randomization phase. OLE phase (Week 1 up to Week 192): Participants who were eligible and agreed to enroll in an OLE phase, will receive troriluzole 140 mg capsules orally once daily for the first 4 weeks in a blinded manner. After OLE Week 4, all participants will then receive open label troriluzole 200 mg up to Week 192.
Drug: troriluzole · Drug: Placebo
Administered orally
Administered orally
Randomization Phase: Change From Baseline in the Modified Functional Scale for the Assessment and Rating of Ataxia (f-SARA) Total Score at Week 48 in SCA Participants
The f-SARA was a 4-item performance based scale: 1-gait, 2-stance, 3-sitting, 4-speech disturbance (0:normal (no impairment), 1: mildly impaired function, but no assistance required, 2: moderately impaired function, but needs assistance for certain parts of task, 3: severely impaired function to degree that assistance is needed for all parts of the task, 4: unable to perform function). Total score was derived as sum of individual items; ranged from 0 to 16. Higher score indicated worst outcome. A negative change in score showed improvement.
Time frame: Randomization Baseline; Week 48
Randomization Phase: Change From Baseline in Patient Impression of Function and Activities of Daily Living Scale (PIFAS) Total Score at Week 48 in SCA Participants
PIFAS was a 17-item instrument designed to assess the level of functional disability. The scale was rater administered and the items were selected to encompass domains of relevance to SCA (i.e., mobility, speech/swallowing, and fatigue), and to capture function and activities of daily living within these domains. Statements were rated on a 5-point Likert scale ranging from "0" reflecting "not at all" to "4" reflecting "very much." The total score was derived as the sum of the individual items, ranged between 0 to 68. Higher score indicated a worst outcome. A negative change in score showed improvement.
Time frame: Randomization Baseline, Week 48
Randomization Phase: Change From Baseline in Friedreich's Ataxia Rating Scale - Activities of Daily Living (FARS-ADL) Total Score at Week 48 in SCA Participants
FARS was a scale consisting of combined timed measures of performance, FUNC (0-6, higher score indicated worst outcome), ADL with paramount neurologic examination (0-36, higher score indicated worst outcome), FARSn (0-125, higher score indicated worst outcome). Total score was sum of these 3 subscales: 0-167, higher score indicated worst outcome. For this outcome measure, only FARS-ADL sub-scale was evaluated. It was multicomponent scale designed to assess neurological domains affected in Friedreich's Ataxia, another hereditary cerebellar ataxia disorder. This subscale had been validated in Friedreich's ataxia, was a measure of functional disability, and correlated with SARA total scores. It assessed 9 areas of ADL with response categories rated on 5-point scale with "0" reflecting "normal" and "4" reflecting inability to perform specific function. Total score was derived as sum of individual items, ranging 0-36, higher score indicated worst outcome. FARS-ADL was rater administered.
Time frame: Randomization Baseline, Week 48
Randomization Phase: Change From Baseline in Functional Staging for Ataxia Scale From the Friedreich's Ataxia Rating Scale (FARS-FUNC) Total Score at Week 48 in SCA Participants
FARS was a scale consisting of combined timed measures of performance, FUNC (0-6, higher score indicated worst outcome), ADL with paramount neurologic examination (0-36, higher score indicated worst outcome), FARSn (0-125, higher score indicated worst outcome). The total score was a sum of these 3 subscales; 0-167, higher score indicated worst outcome. For this outcome measure, only the FARS-FUNC sub-scale was evaluated. FARS-FUNC was a subscale of the FARS designed to provide functional staging for ataxia in which clinicians were asked to assess function on a 6-stage staging system, with "0" reflecting "normal" and "6" reflecting a stage in participant was "total disabled".
Time frame: Randomization Baseline, Week 48
Randomization Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (TESAEs); and AEs Leading to Treatment Discontinuation
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant that did not necessarily had a causal relationship with this treatment. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect in the offspring of the participant or was considered another important medical event. Treatment-emergent AEs (TEAEs) in the randomization phase included any 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.
Time frame: From first dose of study drug to Week 48 plus 30 days (maximum duration: 52 weeks)
Randomization Phase: Change From Baseline in the f-SARA Total Score at Week 48 in SCA3 Participants
The f-SARA was a 4-item performance based scale: 1-gait, 2-stance, 3-sitting, 4-speech disturbance (0:normal (no impairment), 1:mildly impaired function, but no assistance required, 2:moderately impaired function, but needs assistance for certain parts of task, 3: severely impaired function to degree that assistance is needed for all parts of the task, 4:unable to perform function). Total score was derived as sum of individual items; ranged from 0 to 16. Higher score indicated worst outcome. A negative change in score shows improvement.
Time frame: Randomization Baseline; Week 48
Randomization Phase: Change From Baseline in PIFAS Total Score at Week 48 in SCA3 Participants
PIFAS was a 17-item instrument designed to assess the level of functional disability. The scale is rater administered and the items were selected to encompass domains of relevance to SCA (i.e., mobility, speech/swallowing, and fatigue), and to capture function and activities of daily living within these domains. Statements are rated on a 5-point Likert scale ranging from "0" reflecting "not at all" to "4" reflecting "very much." The total score is derived as the sum of the individual items, ranged between 0 to 68. Higher score indicated a worst outcome. A negative change in score showed improvement.
Time frame: Randomization Baseline, Week 48
Randomization Phase: Change From Baseline in FARS-ADL Total Score at Week 48 in SCA3 Participants
FARS was a scale consisting of combined timed measures of performance, FUNC (0-6, higher score indicated worst outcome), ADL with paramount neurologic examination (0-36, higher score indicated worst outcome), FARSn (0-125, higher score indicated worst outcome). Total score was sum of these 3 subscales: 0-167, higher score indicated worst outcome. For this outcome measure, only FARS-ADL sub-scale was evaluated. It was multicomponent scale designed to assess neurological domains affected in Friedreich's Ataxia, another hereditary cerebellar ataxia disorder. This subscale had been validated in Friedreich's ataxia, was a measure of functional disability, and correlated with SARA total scores. It assessed 9 areas of ADL with response categories rated on 5-point scale with "0" reflecting "normal" and "4" reflecting inability to perform specific function. Total score was derived as sum of individual items, ranging 0-36, higher score indicated worst outcome. FARS-ADL was rater administered.
Time frame: Randomization Baseline, Week 48
Randomization Phase: Change From Baseline in FARS-FUNC Total Score at Week 48 in SCA3 Participants
FARS was a scale consisting of combined timed measures of performance, FUNC (0-6, higher score indicated worst outcome), ADL with paramount neurologic examination (0-36, higher score indicated worst outcome), FARSn (0-125, higher score indicated worst outcome). The total score was a sum of these 3 subscales; 0-167, higher score indicated worst outcome. For this outcome measure, only the FARS-FUNC sub-scale was evaluated. FARS-FUNC was a subscale of the FARS designed to provide functional staging for ataxia in which clinicians were asked to assess function on a 6-stage staging system, with "0" reflecting "normal" and "6" reflecting a stage in participant was "total disabled".
Time frame: Randomization Baseline, Week 48
Change From Baseline in Clinical Global Impression - Global Improvement Scale (CGI-I) in SCA3 Participants
The CGI-I was a 7-point scale that required the clinician to assess how much the participant's illness had improved or worsened relative to the baseline visit and it was rated on a 7 point scale: 1= "Very much improved", 2= "Much improved", 3= "Minimally improved", 4= "No change", 5= "Minimally worse", 6= "Much worse" and 7= "Very much worse". Higher scores indicated greater impairment.
Time frame: Randomization Baseline; Week 48
Falls Events in Troriluzole Compared to Placebo for All SCA Participants
An AE of Fall was recorded if there was a worsening of frequency of falls or if a fall was associated with an injury.
Time frame: Randomization Baseline, Week 48
The study was conducted at 23 sites in 2 countries (21 sites in the US and 2 sites in China).
| Milestone | Troriluzole | Placebo |
|---|---|---|
| Started | 109 | 109 |
| Treated | 108 | 109 |
| Completed | 96 | 96 |
| Not completed | 13 | 13 |
| Withdrew: Adverse event | 3 | 5 |
| Withdrew: Withdrawal by subject | 6 | 3 |
| Withdrew: Investigators decision | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Randomized but not treated | 1 | 0 |
The f-SARA was a 4-item performance based scale: 1-gait, 2-stance, 3-sitting, 4-speech disturbance (0:normal (no impairment), 1: mildly impaired function, but no assistance required, 2: moderately impaired function, but needs assistance for certain parts of task, 3: severely impaired function to degree that assistance is needed for all parts of the task, 4: unable to perform function). Total score was derived as sum of individual items; ranged from 0 to 16. Higher score indicated worst outcome. A negative change in score showed improvement.
| score on a scale | Troriluzole | Placebo |
|---|---|---|
| All SCA | 0.20 ± 0.19 | 0.27 ± 0.18 |
| SCA3 | -0.03 ± 0.20 | 0.53 ± 0.19 |
PIFAS was a 17-item instrument designed to assess the level of functional disability. The scale was rater administered and the items were selected to encompass domains of relevance to SCA (i.e., mobility, speech/swallowing, and fatigue), and to capture function and activities of daily living within these domains. Statements were rated on a 5-point Likert scale ranging from "0" reflecting "not at all" to "4" reflecting "very much." The total score was derived as the sum of the individual items, ranged between 0 to 68. Higher score indicated a worst outcome. A negative change in score showed improvement.
| score on a scale | Troriluzole | Placebo |
|---|---|---|
| All SCA | -0.93 ± 1.49 | 1.03 ± 1.43 |
| SCA3 | 0.56 ± 1.65 | 2.96 ± 1.67 |
FARS was a scale consisting of combined timed measures of performance, FUNC (0-6, higher score indicated worst outcome), ADL with paramount neurologic examination (0-36, higher score indicated worst outcome), FARSn (0-125, higher score indicated worst outcome). Total score was sum of these 3 subscales: 0-167, higher score indicated worst outcome. For this outcome measure, only FARS-ADL sub-scale was evaluated. It was multicomponent scale designed to assess neurological domains affected in Friedreich's Ataxia, another hereditary cerebellar ataxia disorder. This subscale had been validated in Friedreich's ataxia, was a measure of functional disability, and correlated with SARA total scores. It assessed 9 areas of ADL with response categories rated on 5-point scale with "0" reflecting "normal" and "4" reflecting inability to perform specific function. Total score was derived as sum of individual items, ranging 0-36, higher score indicated worst outcome. FARS-ADL was rater administered.
| score on a scale | Troriluzole | Placebo |
|---|---|---|
| All SCA | 0.453 ± 0.502 | -0.017 ± 0.480 |
| SCA3 | 0.918 ± 0.523 | 1.130 ± 0.506 |
FARS was a scale consisting of combined timed measures of performance, FUNC (0-6, higher score indicated worst outcome), ADL with paramount neurologic examination (0-36, higher score indicated worst outcome), FARSn (0-125, higher score indicated worst outcome). The total score was a sum of these 3 subscales; 0-167, higher score indicated worst outcome. For this outcome measure, only the FARS-FUNC sub-scale was evaluated. FARS-FUNC was a subscale of the FARS designed to provide functional staging for ataxia in which clinicians were asked to assess function on a 6-stage staging system, with "0" reflecting "normal" and "6" reflecting a stage in participant was "total disabled".
| score on a scale | Troriluzole | Placebo |
|---|---|---|
| All SCA | 0.266 ± 0.075 | 0.226 ± 0.072 |
| SCA3 | 0.216 ± 0.079 | 0.328 ± 0.077 |
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant that did not necessarily had a causal relationship with this treatment. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect in the offspring of the participant or was considered another important medical event. Treatment-emergent AEs (TEAEs) in the randomization phase included any 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.
| participants | Troriluzole | Placebo |
|---|---|---|
| TEAEs | 87 | 92 |
| TESAEs | 6 | 8 |
| AEs Leading to Treatment Discontinuation | 5 | 5 |
The f-SARA was a 4-item performance based scale: 1-gait, 2-stance, 3-sitting, 4-speech disturbance (0:normal (no impairment), 1:mildly impaired function, but no assistance required, 2:moderately impaired function, but needs assistance for certain parts of task, 3: severely impaired function to degree that assistance is needed for all parts of the task, 4:unable to perform function). Total score was derived as sum of individual items; ranged from 0 to 16. Higher score indicated worst outcome. A negative change in score shows improvement.
| score on a scale | Troriluzole | Placebo |
|---|---|---|
| Randomization Phase: Change From Baseline in the f-SARA Total Score at Week 48 in SCA3 Participants | -0.03 ± 0.20 | 0.53 ± 0.19 |
PIFAS was a 17-item instrument designed to assess the level of functional disability. The scale is rater administered and the items were selected to encompass domains of relevance to SCA (i.e., mobility, speech/swallowing, and fatigue), and to capture function and activities of daily living within these domains. Statements are rated on a 5-point Likert scale ranging from "0" reflecting "not at all" to "4" reflecting "very much." The total score is derived as the sum of the individual items, ranged between 0 to 68. Higher score indicated a worst outcome. A negative change in score showed improvement.
| score on a scale | Troriluzole | Placebo |
|---|---|---|
| Randomization Phase: Change From Baseline in PIFAS Total Score at Week 48 in SCA3 Participants | 0.56 ± 1.65 | 2.96 ± 1.67 |
FARS was a scale consisting of combined timed measures of performance, FUNC (0-6, higher score indicated worst outcome), ADL with paramount neurologic examination (0-36, higher score indicated worst outcome), FARSn (0-125, higher score indicated worst outcome). Total score was sum of these 3 subscales: 0-167, higher score indicated worst outcome. For this outcome measure, only FARS-ADL sub-scale was evaluated. It was multicomponent scale designed to assess neurological domains affected in Friedreich's Ataxia, another hereditary cerebellar ataxia disorder. This subscale had been validated in Friedreich's ataxia, was a measure of functional disability, and correlated with SARA total scores. It assessed 9 areas of ADL with response categories rated on 5-point scale with "0" reflecting "normal" and "4" reflecting inability to perform specific function. Total score was derived as sum of individual items, ranging 0-36, higher score indicated worst outcome. FARS-ADL was rater administered.
| score on a scale | Troriluzole | Placebo |
|---|---|---|
| Randomization Phase: Change From Baseline in FARS-ADL Total Score at Week 48 in SCA3 Participants | 0.918 ± 0.523 | 1.130 ± 0.506 |
FARS was a scale consisting of combined timed measures of performance, FUNC (0-6, higher score indicated worst outcome), ADL with paramount neurologic examination (0-36, higher score indicated worst outcome), FARSn (0-125, higher score indicated worst outcome). The total score was a sum of these 3 subscales; 0-167, higher score indicated worst outcome. For this outcome measure, only the FARS-FUNC sub-scale was evaluated. FARS-FUNC was a subscale of the FARS designed to provide functional staging for ataxia in which clinicians were asked to assess function on a 6-stage staging system, with "0" reflecting "normal" and "6" reflecting a stage in participant was "total disabled".
| score on a scale | Troriluzole | Placebo |
|---|---|---|
| Randomization Phase: Change From Baseline in FARS-FUNC Total Score at Week 48 in SCA3 Participants | 0.216 ± 0.079 | 0.328 ± 0.077 |
The CGI-I was a 7-point scale that required the clinician to assess how much the participant's illness had improved or worsened relative to the baseline visit and it was rated on a 7 point scale: 1= "Very much improved", 2= "Much improved", 3= "Minimally improved", 4= "No change", 5= "Minimally worse", 6= "Much worse" and 7= "Very much worse". Higher scores indicated greater impairment.
| score on a scale | Troriluzole | Placebo |
|---|---|---|
| Change From Baseline in Clinical Global Impression - Global Improvement Scale (CGI-I) in SCA3 Participants | 4.14 ± 0.17 | 4.68 ± 0.17 |
An AE of Fall was recorded if there was a worsening of frequency of falls or if a fall was associated with an injury.
| Number of events | Troriluzole | Placebo |
|---|---|---|
| Falls Events in Troriluzole Compared to Placebo for All SCA Participants | 20 | 42 |
Collected over For Adverse events (AEs): From first dose of study drug up to Week 48 plus 30 days (maximum duration: 52 weeks) For All-cause mortality: From randomization up to Week 48 plus 30 days (maximum duration: 52 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Troriluzole | 1/109 (0.9%) | 6/108 (5.6%) | 54/108 (50%) |
| Placebo | 1/109 (0.9%) | 8/109 (7.3%) | 58/109 (53.2%) |
| Event | Troriluzole | Placebo |
|---|---|---|
| Urinary tract infectionInfections and infestations | 0/108 | 2/109 |
| Suicide attemptPsychiatric disorders | 0/108 | 2/109 |
| FallInjury, poisoning and procedural complications | 1/108 | 0/109 |
| Humerus fractureInjury, poisoning and procedural complications | 1/108 | 0/109 |
| Pulmonary contusionInjury, poisoning and procedural complications | 1/108 | 0/109 |
| Rib fractureInjury, poisoning and procedural complications | 1/108 | 0/109 |
| Human chorionic gonadotropin positiveInvestigations | 1/108 | 0/109 |
| Liver function test increasedInvestigations | 1/108 | 0/109 |
| COVID-19Infections and infestations | 1/108 | 0/109 |
| PneumatosisGeneral disorders | 1/108 | 0/109 |
| Event | Troriluzole | Placebo |
|---|---|---|
| FallInjury, poisoning and procedural complications | 13/108 | 24/109 |
| HeadacheNervous system disorders | 13/108 | 8/109 |
| DizzinessNervous system disorders | 9/108 | 11/109 |
| FatigueGeneral disorders | 10/108 | 9/109 |
| Muscle SpasmsMusculoskeletal and connective tissue disorders | 6/108 | 9/109 |
| ContusionInjury, poisoning and procedural complications | 7/108 | 7/109 |
| NauseaGastrointestinal disorders | 7/108 | 1/109 |
| Upper Respiratory Tract InfectionInfections and infestations | 5/108 | 7/109 |
| Urinary Tract InfectionInfections and infestations | 5/108 | 7/109 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/108 | 7/109 |
Treated analysis set (TAS): The treated analysis set included all randomized/enrolled participants who received at least one dose of study medication (blinded or open label troriluzole, or blinded placebo).
| Age, Continuous(years) | Troriluzole | Placebo | Total |
|---|---|---|---|
| Mean | 47.7 ± 13.16 | 47.6 ± 12.48 | 47.6 ± 12.79 |
| Sex: Female, Male(Participants) | Troriluzole | Placebo | Total |
|---|---|---|---|
| Female | 50 | 56 | 106 |
| Male | 58 | 53 | 111 |
| Ethnicity (NIH/OMB)(Participants) | Troriluzole | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 11 | 24 |
| Not Hispanic or Latino | 95 | 98 | 193 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Troriluzole | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 19 | 21 | 40 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 12 | 14 | 26 |
| White | 74 | 74 | 148 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Number of Participants with Spinocerebellar ataxia (SCA) Genotype(participants) | Troriluzole | Placebo | Total |
|---|---|---|---|
| SCA1 | 15 | 11 | 26 |
| SCA2 | 32 | 35 | 67 |
| SCA3 | 44 | 45 | 89 |
| SCA6 | 6 | 6 | 12 |
| SCA7 | 5 | 5 | 10 |
| SCA8 | 3 | 2 | 5 |
| SCA10 | 3 | 5 | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2019 to primary completion in Feb 2022, 35 months.
Results were first posted in Feb 2025, 2 years 11 months after primary completion. A results delay was requested in Jan 2023.
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Studies of the drug tested here: Troriluzole
Biohaven Pharmaceuticals, Inc.