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 |
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).
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
18
sites
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Phone: 410-616-2811
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Phone: 773-702-5545
University of Chicago One of the world's premier academic and research institutions, the University of...
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Los Angeles, California 90095
310-825-4321
Phone: 310-206-8153
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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116th St and Broadway
New York, New York 10027
New York, New York 10027
(212) 854-1754
Phone: 212-305-5779
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2100
Phone: 585-276-5966
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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4202 E Fowler Ave
Tampa, Florida 33620
Tampa, Florida 33620
(813) 974-2011
Phone: 813-974-5909
University of South Florida The University of South Florida is a high-impact, global research university...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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330 Brookline Avenue
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Phone: 617-667-0453
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350 W Thomas Rd
Phoenix, Arizona 85013
Phoenix, Arizona 85013
(602) 406-3000
Phone: 602-406-3719
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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