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Pro-Drug

BHV-4157 for Ataxia

Phase 3
Waitlist Available
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age and Sex a. Male and female outpatient subjects between the ages of 18 - 75, inclusive
Non-genetic pure cerebellar and MSA-C subjects will be limited to Inclusion Criteria of Screening SARA score ≥8 or Score of ≥ 2 on gait subsection of the SARA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial is to test the efficacy of BHV-4157 in treating cerebellar ataxia in adults. Patients will be required to visit UCLA five times over the course of the 12 weeks--once for screening, once for baseline testing, and then once every four weeks. There is also the option to extend the trial for an additional 36 weeks.

Who is the study for?
Adults aged 18-75 with cerebellar ataxia, including specific hereditary ataxias or multiple system atrophy-cerebellar type (MSA-C), who can walk 8 meters and are medically stable. Participants must not be pregnant, use two forms of contraception if applicable, have a minimum of six years education, and be able to comply with study requirements.Check my eligibility
What is being tested?
The trial is testing BHV-4157 over a period of 12 weeks to treat ataxia. BHV-4157 is related to riluzole, an FDA-approved drug for ALS. The trial includes five visits for examinations, tests, ECGs, questionnaires and there's an optional extension phase lasting another 36 weeks.See study design
What are the potential side effects?
While the side effects specific to BHV-4157 aren't listed here as it's under investigation, similar drugs like riluzole may cause dizziness, gastrointestinal issues such as nausea or diarrhea; liver function changes; weakness; and potential risk for low white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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My balance and walking difficulties are moderate to severe.
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I am between 18 and 75 years old.
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I have hereditary ataxia (SCA1, SCA2, SCA3, or SCA6) and have been on Riluzole for over 8 weeks.
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I have a type of ataxia that affects my balance and coordination, not caused by genetics.
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I have been diagnosed with multiple system atrophy of the cerebellar type (MSA-C).
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I have SCA and have been on Riluzole for over 8 weeks.
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I can follow the study's treatment plan, attend all appointments, and communicate openly about side effects and medications.
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I am using effective birth control during and up to 30 days after the study.
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I can walk 8 meters by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Scale for the Assessment and Rating of Ataxia
Secondary outcome measures
8-Meter Walk Test
Beck Anxiety Inventory
Beck Depression Inventory
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open ArmExperimental Treatment1 Intervention
All subjects will receive the same dosage throughout the study.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,521 Previous Clinical Trials
10,278,912 Total Patients Enrolled
2 Trials studying Spinocerebellar Ataxias
1,000 Patients Enrolled for Spinocerebellar Ataxias

Media Library

BHV-4157 (Pro-Drug) Clinical Trial Eligibility Overview. Trial Name: NCT03408080 — Phase 3
Spinocerebellar Ataxias Research Study Groups: Open Arm
Spinocerebellar Ataxias Clinical Trial 2023: BHV-4157 Highlights & Side Effects. Trial Name: NCT03408080 — Phase 3
BHV-4157 (Pro-Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03408080 — Phase 3

Frequently Asked Questions

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

Am I eligible to participate in this research?

"The ideal candidates for this clinical trial are those suffering from spinocerebellar ataxias who fall between the ages of 18 and 75. So far, around 24 people have met the requirements."

Answered by AI

Does this research include geriatric patients in the test group?

"To be eligible for this study, patients must fall between the ages of 18-75. There are 19 similar studies recruiting patients that are underaged and 33 trials for seniors."

Answered by AI

Are people currently being recruited for this experiment?

"According to the most recent update on clinicaltrials.gov, this particular trial is not recruiting patients at the moment. The original posting was on December 15th, 2017 however the last update was on June 10th, 2022. There are other 47 trials that are currently looking for participants though."

Answered by AI

What are the deleterious effects of BHV-4157?

"BHV-4157 was given a safety score of 3. This is based on the fact that it is currently in Phase 3 trials, meaning that there is both efficacy and safety data available."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
University of California, Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Apr 2024