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Glutamate Modulator

Troriluzole for Spinocerebellar Ataxia

Phase 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
Subjects with a known or suspected diagnosis of specific hereditary ataxias: SCA1, SCA2, SCA3, SCA7, and SCA10
Subjects with a known or suspected diagnosis of the following specific hereditary ataxias: SCA1, SCA2, SCA3, SCA6, SCA7, SCA8 and SCA10; currently only enrolling SCA 1, SCA2, SCA3, SCA7, and SCA10 (the cap has been met for SCA6 and SCA8 (on May 31, 2019));
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 48
Awards & highlights

Study Summary

This trial will compare Troriluzole to a placebo to see if it is more effective in treating SCA after 48 weeks.

Who is the study for?
Adults with spinocerebellar ataxia (SCA) types SCA1, SCA2, SCA3, SCA7, and SCA10 who can walk 8 meters unaided (devices okay), have a specific score on the f-SARA gait test, and are medically stable. Those with severe cognitive impairment or conditions that could affect their ataxia severity aren't eligible.Check my eligibility
What is being tested?
The trial is testing Troriluzole (200mg daily) against a placebo over 48 weeks to see if it's more effective in treating symptoms of spinocerebellar ataxia. Participants will be randomly assigned to either the drug or placebo group.See study design
What are the potential side effects?
While not specified here, potential side effects for Troriluzole may include nausea, dizziness, fatigue or other common drug-related reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have or might have a specific type of hereditary ataxia (SCA1, SCA2, SCA3, SCA7, or SCA10).
Select...
I have been diagnosed with a specific type of hereditary ataxia (SCA1, SCA2, SCA3, SCA7, or SCA10).
Select...
My condition has been genetically confirmed by a certified lab, or I have a family member with a confirmed diagnosis and I am willing to undergo genetic testing.
Select...
My doctor considers me medically stable based on my recent health checks.
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I can walk 8 meters by myself, but I can use a cane or other aid if needed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 48 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 the total score of the Modified Functional Scale for the Assessment and Rating of Ataxia (f-SARA) after 48 weeks of treatment.
Secondary outcome measures
1. Change from baseline in Patient Impression of Function and Activities of Daily Living Scale (PIFAS) score at Randomization Phase Week 48
4. Frequency of subjects with the following adverse events (AEs) identified from case report forms: AEs (by severity; by relationship to study drug; overall); SAEs; and AEs leading to treatment discontinuation.
Change from baseline in Activities of Daily Living Scale from the Friedreich's Ataxia Rating Scale (FARS-ADL) at Randomization Week 48.
+1 more

Side effects data

From 2021 Phase 2 trial • 350 Patients • NCT03605667
11%
Fall
6%
Urinary tract infection
6%
Coronavirus infection
3%
Dizziness
3%
Headache
3%
Anxiety
2%
Liver function test increased
1%
Decreased appetite
1%
Colonic abscess
1%
Rib fracture
1%
Pelvic fracture
1%
Diarrhoea
1%
Faecaloma
1%
Respiratory failure
1%
Orthostatic hypotension
1%
Hip fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Troriluzole - Randomization Phase/ Troriluzole - OLE Phase
Troriluzole - Randomization Phase
Placebo - Randomization Phase/ Troriluzole - OLE Phase
Placebo - Randomization Phase

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1: BHV-4157Experimental Treatment1 Intervention
Troriluzole 200mg by mouth
Group II: Arm 2: PlaceboPlacebo Group1 Intervention
Placebo 200mg by mouth
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
troriluzole
2018
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
36,917 Total Patients Enrolled
2 Trials studying Spinocerebellar Ataxias
141 Patients Enrolled for Spinocerebellar Ataxias

Media Library

Troriluzole (Glutamate Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03701399 — Phase 3
Spinocerebellar Ataxias Research Study Groups: Arm 2: Placebo, Arm 1: BHV-4157
Spinocerebellar Ataxias Clinical Trial 2023: Troriluzole Highlights & Side Effects. Trial Name: NCT03701399 — Phase 3
Troriluzole (Glutamate Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03701399 — Phase 3
Spinocerebellar Ataxias Patient Testimony for trial: Trial Name: NCT03701399 — Phase 3

Frequently Asked Questions

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

How many subjects are you testing this medication on?

"This particular clinical trial is not recruiting patients at this time. It was originally posted on March 8th, 2019 but the most recent update was on October 4th, 2022. There are currently 47 other trials searching for participants that have spinocerebellar ataxia type 3 and 6 studies involving troriluzole are actively admitting patients."

Answered by AI

Does this research stand alone or has it been done before?

"As of right now, there are 6 ongoing trials for troriluzole in 8 countries and 161 cities. The first trial was conducted in 2016 and completed both its Phase 2 & 3 stages that same year. Since then, 243 clinical studies have been carried out."

Answered by AI

Has the United States Food and Drug Administration cleared troriluzole for public use?

"There is some evidence, from previous Phase 3 trials, to support the efficacy of troriluzole. Furthermore, there is also backing from multiple rounds of data that suggest troriluzole is safe. Consequently, our team rates it as a level 3 on the Power scale."

Answered by AI

If a patient is over the age of 40, can they still participate in this research?

"This study is looking for participants that fall in the age range of 18 to 75 years old."

Answered by AI

Are we still enrolling people for this trial?

"This study has since closed recruitment and is no longer looking for patients. The trial was originally posted on 3/8/2019 and was last edited on 10/4/2022. 47 other studies are currently enrolling participants with spinocerebellar ataxia type 3 while 6 trials for troriluzole are actively admitting participants."

Answered by AI

Who meets the requirements to be a part of this clinical trial?

"This study is looking for 218 participants who currently have spinocerebellar ataxia type 3 and meet the following criteria: A subject has clinical evidence that supports diagnosis of one of the aforementioned SCA genotypes but does not have producible test results from a CLIA certified lab from either a family member or for his or herself and the subject must be willing to undergo such testing to confirm the SCA diagnosis (in this case, site must wait for results of genotypic testing prior to randomization), Screening f-SARA total score ≥3;, Score of ≥1 on gait subsection of the"

Answered by AI

What other scientific research has been conducted on troriluzole?

"There are a total of 6 ongoing clinical trials testing troriluzole's efficacy, 5 of which are in Phase 3. While several locations for these studies are situated in San Antonio, Texas, there are a grand total of 424 sites running trials for troriluzole across the globe."

Answered by AI

In how many different medical clinics is this clinical trial being performed today?

"There are a total of 21 sites for this study, including but not limited to Houston Methodist in Houston, University of Colorado Hospital in Aurora, and University of Florida Health in Gainesville."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
New York
Tennessee
How old are they?
18 - 65
What site did they apply to?
UCSF
University of Colorado Hospital
Massachusetts General Hospital
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I am wanting to see if there are other prescriptions that would be helpful to me.
PatientReceived 1 prior treatment
I have an account at mypennmedicine. I have Ataxia with cervical spondylosis and a vitamin e deficiency. Is there compensation?
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
Troriluzole in Adult Subjects With Spinocerebellar Ataxia
2019. "Troriluzole in Adult Subjects With Spinocerebellar Ataxia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03701399.
All > Spinocerebellar Ataxia
~36 spots leftby Apr 2025
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