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NCT06529146 · ClinicalTrials.gov registry record
Real-World Data Study of Troriluzole-Treated Patients With Spinocerebellar Ataxia (SCA) Compared to a Matched Natural History Control
A clinical trial of Spinocerebellar Ataxias, sponsored by Biohaven Therapeutics.
- Active
- Registry status
- 909
- Enrollment target
- 1
- Study location
NCT06529146: Active study of Spinocerebellar Ataxias, sponsored by Biohaven Therapeutics.
NCT06529146 is a study of Spinocerebellar Ataxias that is active but no longer recruiting, run by Biohaven Therapeutics. The registered enrollment target is 909 participants, above the 297-participant average among 5 other Spinocerebellar Ataxias trials with a reported enrollment target (206% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06529146, a study of Spinocerebellar Ataxias, is active but no longer recruiting, sponsored by Biohaven Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- 909 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to leverage two sources of real-world data (RWD) to assess the effectiveness of troriluzole after three years of treatment in patients with SCA by comparison to an external control of untreated patients who were followed in a natural history cohort. Real world evidence of effectiveness will be assessed from the RWD sources to examine the treatment effects of toriluzole in SCA out to 3 years. Progression rates of SCA differ by genotype and long-term follow-up is needed to assess for potential efficacy in this rare disease.
Primary Outcome
To compare the effectiveness of troriluzole in treating SCA, as measure by the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA), in subjects randomized to treatment with troriluzole relative to natural history controls from the natural history dataset after 3 years of treatment. The f-SARA is a scale with a range of 0 to 16, where an increase in the total score indicates a worsening of symptoms.
Conditions Studied
Interventions
- DRUG BHV-4157
Study Locations (1)
Connecticut
- Biohaven - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 909 participants |
| Start Date | 2019-03-18 |
| Est. Completion | 2026-06 |
What the registry record for NCT06529146 still lists
NCT06529146 is an observational study that tracks outcomes without assigning an intervention. The registered 909 participants enrollment target is mid-sized for trials with a published cap, above the 297-participant average among 5 other Spinocerebellar Ataxias trials with a reported enrollment target (206% higher).
The record links to 1 condition, with Spinocerebellar Ataxias appearing as the primary indexed condition, and to 1 intervention - of which BHV-4157 is the first listed.
NCT06529146 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06529146 about?
NCT06529146 is a clinical study titled "Real-World Data Study of Troriluzole-Treated Patients With Spinocerebellar Ataxia (SCA) Compared to a Matched Natural History Control". The purpose of this study is to leverage two sources of real-world data (RWD) to assess the effectiveness of troriluzole after three years of treatment in patients with SCA by comparison to an external control of untreated patients who were followed in a natural history cohort. Real world evidence ...
What is the current status of trial NCT06529146?
This trial is currently active not recruiting. The enrollment target is 909 participants. The study started on 2019-03-18. Estimated completion is 2026-06.
What conditions does trial NCT06529146 study?
This clinical trial studies the following conditions: Spinocerebellar Ataxias.
What interventions are being tested in trial NCT06529146?
The interventions under investigation include: BHV-4157 (DRUG).
Who is sponsoring clinical trial NCT06529146?
This trial is sponsored by Biohaven Therapeutics, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06529146 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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