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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));
Must not have
MMSE score <24
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 48
Awards & highlights
Pivotal Trial
Summary
This trial is testing whether a medication called Troriluzole can help people with spinocerebellar ataxia by balancing a brain chemical to prevent damage. Troriluzole is related to riluzole, which has been shown to prolong survival and slow functional deterioration in patients with ALS.
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.
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.
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 belowSelect...
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...
I can walk 8 meters by myself, but I can use a cane or other aid if needed.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My memory and thinking skills test score is below 24.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 48
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
1. Change from baseline in Patient Impression of Function and Activities of Daily Living Scale (PIFAS) score at Randomization Phase Week 48
Change from baseline in Activities of Daily Living Scale from the Friedreich's Ataxia Rating Scale (FARS-ADL) at Randomization Week 48.
Ataxia
Side effects data
From 2021 Phase 2 trial • 350 Patients • NCT0360566711%
Fall
6%
Coronavirus infection
6%
Urinary tract infection
3%
Dizziness
3%
Headache
3%
Anxiety
2%
Liver function test increased
1%
Respiratory failure
1%
Faecaloma
1%
Colonic abscess
1%
Hip fracture
1%
Pelvic fracture
1%
Rib fracture
1%
Orthostatic hypotension
1%
Diarrhoea
1%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Troriluzole - Randomization Phase/ Troriluzole - OLE Phase
Placebo - Randomization Phase/ Troriluzole - OLE Phase
Troriluzole - Randomization Phase
Placebo - Randomization Phase
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Spinocerebellar Ataxias (SCA) often focus on modulating glutamate activity, as excessive glutamate can lead to neurotoxicity and neuronal damage. Troriluzole, for example, is designed to reduce glutamate release and enhance its reuptake, thereby protecting neurons from excitotoxicity.
This mechanism is crucial for SCA patients because it aims to slow down the progression of neurodegeneration and alleviate symptoms associated with the disease. By stabilizing glutamate levels, these treatments help maintain neuronal function and potentially improve motor coordination and quality of life for SCA patients.
Glutamate stimulates [3H]phorbol 12,13-dibutyrate binding in cultured Bergmann glia cells.Blockade of pilocarpine-induced cerebellar phosphoinositide hydrolysis with metabotropic glutamate antagonists: evidence for an indirect control of granule cell glutamate release by muscarinic agonists.
Glutamate stimulates [3H]phorbol 12,13-dibutyrate binding in cultured Bergmann glia cells.Blockade of pilocarpine-induced cerebellar phosphoinositide hydrolysis with metabotropic glutamate antagonists: evidence for an indirect control of granule cell glutamate release by muscarinic agonists.
Find a Location
Who is running the clinical trial?
Biohaven Pharmaceuticals, Inc.Lead Sponsor
48 Previous Clinical Trials
37,369 Total Patients Enrolled
2 Trials studying Spinocerebellar Ataxias
141 Patients Enrolled for Spinocerebellar Ataxias
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Placebo
- Group 2: Arm 1: BHV-4157
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Spinocerebellar Ataxias Patient Testimony for trial: Trial Name: NCT03701399 — Phase 3
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