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Troriluzole for Spinocerebellar Ataxia
Study Summary
This trial will compare Troriluzole to a placebo to see if it is more effective in treating SCA after 48 weeks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 350 Patients • NCT03605667Trial Design
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Who is running the clinical trial?
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- Your f-SARA total score is 3 or higher during screening.I have or might have a specific type of hereditary ataxia (SCA1, SCA2, SCA3, SCA7, or SCA10).You have severe muscle stiffness or uncontrollable muscle movements that could make it difficult for the SARA instrument to measure the severity of your ataxia.I have been diagnosed with a specific type of hereditary ataxia (SCA1, SCA2, SCA3, SCA7, or SCA10).I have liver disease or a history of bad reactions to medications due to my liver.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.My doctor considers me medically stable based on my recent health checks.I suspect I have a certain genetic disorder but haven't confirmed it with a test yet.My memory and thinking skills test score is below 24.My ataxia symptoms are not caused by another medical condition.I don't have any health issues that could affect my ataxia severity assessment.I can walk 8 meters by myself, but I can use a cane or other aid if needed.Your f-SARA total score is 3 or higher.Your score on a specific test has to be stable between the time you first get screened and the start of the study.If you score 4 on any of the first four items of the f-SARA test.You have a score of 1 or higher on the walking test called f-SARA.
- Group 1: Arm 2: Placebo
- Group 2: Arm 1: BHV-4157
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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"
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."
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