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Glutamate Modulator

Troriluzole for Spinocerebellar Ataxia

Phase 2 & 3
Waitlist Available
Research Sponsored by Biohaven Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to ambulate 8 meters without assistance (canes and other devices allowed)
Subjects with a known or suspected diagnosis of the following specific hereditary ataxias: SCA1, SCA2, SCA3, SCA6, SCA7, SCA8 and SCA10
Timeline
Screening 3 weeks
Treatment Varies
Follow Up aes from first dose of troriluzole to 2 weeks after last dose (up to 50 weeks after last ext subject enrolled or up to 58 weeks after last randomization [rand] subject enrolled). saes from signing of icf to 30 days after the last dose of troriluzole.
Awards & highlights

Study Summary

This trial will compare the effectiveness of a new drug, Troriluzole, to a placebo in treating SCA.

Who is the study for?
This trial is for adults who can walk 8 meters with or without support, have specific types of hereditary ataxia (SCA1, SCA2, SCA3, SCA6, SCA7, SCA8 and SCA10), and a certain level of gait impairment. They should be medically stable and expected to complete the study. Excluded are those with stroke history, significant liver disease or low mental state scores.Check my eligibility
What is being tested?
The trial tests Troriluzole (BHV-4157) at 140 mg daily against a placebo over an 8-week period to see its effectiveness in treating spinocerebellar ataxia—a condition affecting coordination and balance.See study design
What are the potential side effects?
While not specified here, potential side effects may include typical drug reactions such as nausea, headache, dizziness or fatigue. Since Troriluzole affects the nervous system it might also cause mood changes or sleep disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can walk 8 meters by myself, even with a cane or device.
Select...
I have been diagnosed with a specific type of hereditary ataxia.
Select...
I have been diagnosed with a specific type of hereditary ataxia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~aes from first dose of study drug to 2 weeks after the last dose (up to 10 weeks). saes from signing of informed consent form (icf) to the start of the extension (ext) phase or 30 days after the last dose (up to 12 weeks).
This trial's timeline: 3 weeks for screening, Varies for treatment, and aes from first dose of study drug to 2 weeks after the last dose (up to 10 weeks). saes from signing of informed consent form (icf) to the start of the extension (ext) phase or 30 days after the last dose (up to 12 weeks). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Total Score on the Scale for the Assessment and Rating of Ataxia (SARA) at Randomization Phase Week 8
Secondary outcome measures
Therapeutic procedure
Number of Participants With Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment Emergent AEs (TEAEs) During the Extension Phase
Number of Participants With Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-Emergent AEs (TEAEs) During the Randomization Phase
+1 more
Other outcome measures
Change From Randomization Baseline in Total Score on the Scale for the Assessment and Rating of Ataxia (SARA) at Extension Phase Week 48

Side effects data

From 2020 Phase 3 trial • 881 Patients • NCT03829241
9%
Nausea
5%
Fatigue
5%
Upper respiratory tract infection
4%
Headache
3%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - Randomization Phase/Troriluzole - Extension Phase
Troriluzole - Randomization Phase
Placebo - Randomization Phase
Troriluzole - Randomization Phase/Troriluzole - Extension Phase

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TroriluzoleExperimental Treatment1 Intervention
Troriluzole - Randomization Phase: Participants received Troriluzole 140 mg capsules orally once daily (QD) for 8 weeks. Troriluzole/Troriluzole - Extension Phase: Participants received Troriluzole 140 mg capsules orally QD for 48 weeks.
Group II: PlaceboPlacebo Group2 Interventions
Placebo - Randomization Phase: Participants received matching placebo capsules orally QD for 8 weeks. Placebo/Troriluzole - Extension Phase: Participants who received placebo during randomization phase, received Troriluzole 140 mg capsules orally QD for 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Troriluzole
2019
Completed Phase 3
~890

Find a Location

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
36,994 Total Patients Enrolled
2 Trials studying Spinocerebellar Ataxias
218 Patients Enrolled for Spinocerebellar Ataxias

Media Library

Troriluzole (Glutamate Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT02960893 — Phase 2 & 3
Spinocerebellar Ataxias Research Study Groups: Troriluzole, Placebo
Spinocerebellar Ataxias Clinical Trial 2023: Troriluzole Highlights & Side Effects. Trial Name: NCT02960893 — Phase 2 & 3
Troriluzole (Glutamate Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02960893 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients who are over 45 years of age being recruited for this trial?

"This trial is open to adults aged 18 to 75. If an applicant does not fall in this age range, they might still be eligible for one of the 19 clinical trials for people under 18 or the 39 trials for patients over 65."

Answered by AI

What are some other ways Troriluzole has been researched?

"Currently, there are six ongoing Troriluzole studies, five of which are in Phase 3. This treatment is being trialled at 424 locations, the majority of which are based in Bryan, Texas."

Answered by AI

At how many medical facilities can patients enroll in this trial?

"The University of South Florida in Tampa, Florida, CNS Trial in Long Beach, Illinois, Northwestern University in Chicago, Maryland, and 18 other locations are participating in this clinical trial."

Answered by AI

Can new test subjects still enroll in this experiment?

"No, this study is not looking for participants at the moment. The last update on clinicaltrials.gov was on March 31st, 2022. Even though this study is not recruiting, there are 53 other trials that are currently looking for patients."

Answered by AI

What are the unique features of this clinical trial?

"Biohaven Pharmaceuticals, Inc. conducted the first trial for Troriluzole in 2016 with a pool of 141 patients. After the success of the Phase 2 & 3 drug approval, there are now 6 different ongoing trials in 161 different cities and 8 countries."

Answered by AI

Might I be eligible to help with this research?

"Up to 141 individuals between the ages of 18-75, who have been diagnosed with spinocerebellar ataxias, will be enrolled in this clinical trial. Eligible patients must also meet the following requirements: Must be determined by the investigator to be medically stable at baseline/randomization, Must be physically able and expected to complete the trial as designed, Subjects with a known or suspected diagnosis of the following specific hereditary ataxias: SCA1, SCA2, SCA3, SCA6, SCA7, SCA8 and SCA10, Ability to ambulate 8 meters without assistance (can"

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
University of Colorado Denver
University of South Florida
Emory University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
California
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’m hoping to get a new medication that will provide support for balance.
PatientReceived 2+ prior treatments
Recent research and studies
Movement DisordersJournal
Development and Validation of a <scp>patient‐reported</scp> Outcome Measure of Ataxia
Schmahmann, Jeremy D., Samantha Pierce, Jason MacMore, and Gilbert J. L'Italien. 2021. “Development and Validation of a patient‐reported Outcome Measure of Ataxia”. Movement Disorders. Wiley. doi:10.1002/mds.28670.
clinicaltrials.govStudy
Trial in Adult Subjects With Spinocerebellar Ataxia
2016. "Trial in Adult Subjects With Spinocerebellar Ataxia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02960893.
All > Spinocerebellar Ataxia
~17 spots leftby Apr 2025
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