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
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...
Click here to add this to my saved trials
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
University of Michigan The University of Michigan was founded in 1817 as one of the...
Click here to add this to my saved trials
Click here to add this to my saved trials
330 Brookline Avenue
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Phone: 617-667-0453
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials