Trial in Adult Subjects With Spinocerebellar Ataxia



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 75
Updated:8/10/2018
Start Date:December 2016
End Date:August 2019

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A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 in Adult Subjects With Spinocerebellar Ataxia

The primary purpose of this study is to compare the efficacy of BHV-4157 versus placebo after
8 weeks of treatment on ataxia symptoms in subjects with spinocerebellar ataxia (SCA).


Inclusion Criteria:

- Subjects with a known or suspected diagnosis of the following specific hereditary
ataxias: SCA1, SCA2, SCA3 (A Maximum of 12 patients will be enrolled with this
genotype- FEB 1 2017 -THIS CAP HAS BEEN MET FOR SCA3), SCA6, SCA7, SCA8 and SCA10

- Ability to ambulate 8 meters without assistance (canes and other devices allowed)

- Screening total SARA total score ≥8

- Determined by the investigator to be medically stable at baseline/randomization and
must be physically able and expected to complete the trial as designed

- Subjects must have adequate hearing, vision, and language skills to perform Scale for
the Assessment and Rating of Ataxia (SARA) ratings, 8 Meter Walk Test and other
neuropsychiatric testing and interviews as specified in the protocol

Exclusion Criteria:

- Any medical condition other than one of the hereditary ataxias specified in the
inclusion criteria that could predominantly explain or contribute significantly to the
subjects' symptoms of ataxia

- Mini Mental State Exam (MMSE) score < 24

- SARA total score of > 30 points at screening

- Clinical history of stroke

- Active liver disease or a history of hepatic intolerance to medications that in the
investigator's judgment, is medically significant
We found this trial at
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Boston, Massachusetts 02114
Phone: 617-726-4961
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201 Dowman Dr
Atlanta, Georgia 30303
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3400 N Charles St
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5801 South Ellis Avenue
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Gainesville, Florida 32610
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4202 E Fowler Ave
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330 Brookline Avenue
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