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Could a drug slow rare brain disease? new study uses Real-World data to find out

NCT ID NCT06529146

Disease control Sponsor: Biohaven Therapeutics Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether the drug troriluzole can slow the progression of spinocerebellar ataxia (SCA), a rare genetic disease that affects movement and balance. Researchers will compare 909 patients who took troriluzole for up to three years with similar patients who did not receive the drug, using data from natural history studies. The main goal is to see if treated patients have less worsening on a scale that measures coordination and daily function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
troriluzole (BHV-4157)
What this could lead to
If successful, this could show that troriluzole slows the worsening of movement problems in people with spinocerebellar ataxia over three years.
What could go wrong
This is a real-world data study, not a controlled trial, so results may be less reliable. The disease is rare and varies by genetic type, making it hard to prove effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

909 people

The number who actually took part.

Started

Mar 2019

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study involves the analysis of data collected among three research settings: 1) European registry of SCA patients (2005-2008) (NCT02440763 ); 2) US registry of SCA patients (2010-present) (NCT01060371); 3) Subjects originally randomized to troriluzole in BHV4157-206 with 3-years of treatment data (NCT03701399).

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria for troriluzole-treated participants (BHV4157-206): * Between the ages of 18-75 * Genetic confirmation of the following specific hereditary ataxias: SCA1, SCA2, SCA3, SCA6, SCA7, SCA8, and SCA10 * Screening f-SARA total score of ≥3 and score of ≥1 on gait item of the f-SARA. * Ability to ambulate 8 meters without human assistance (canes and other devices were allowed) * Subjects initially randomized to troriluzole Key Inclusion Criteria for participants selected from the natural history studies: * Between ages of 18-75 * CRC-SCA: either a genetic confirmation or a diagnosis of SCA 1, 2, 3, 6, 7, 8, and 10 in themselves or a family member; EUROSCA: genetic confirmation of SCA genotypes 1, 2, 3 and 6. Key Exclusion Criteria for troriluzole-treated participants (BHV4157-206 study): * Screening f-SARA score of 4 on any item of the f-SARA * Any other medical condition that could predominantly explain or contribute significantly to the subjects' symptoms of ataxia or that could confound assessment of ataxia symptoms Key Exclusion Criteria for participants selected from the natural history studies: • Treatment with troriluzole

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Conditions

The condition(s) this trial relates to.

autosomal dominant cerebellar ataxia Machado-Joseph disease spinocerebellar ataxia 7 spinocerebellar ataxia type 1 spinocerebellar ataxia type 10 spinocerebellar ataxia type 2 spinocerebellar ataxia type 6 spinocerebellar ataxia type 8 Spinocerebellar Ataxias

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinocerebellar ataxias

Contacts and locations

Locations

  • Biohaven

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.