Troriluzole in Adult Subjects With Spinocerebellar Ataxia
Status: | Recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/3/2019 |
Start Date: | March 8, 2019 |
End Date: | October 31, 2020 |
Contact: | Robert Berman, MD |
Email: | clinicaltrials@biohavenpharma.com/ |
Phone: | 203-404-0410 |
A Phase III, Long-Term, Randomized, Double-blind, Placebo-controlled Trial of Troriluzole in Adult Subjects With Spinocerebellar Ataxia.
The purpose of this study is to compare the efficacy of Troriluzole (200mg once daily) versus
placebo after 48 weeks of treatment in subjects with spinocerebellar ataxia (SCA).
placebo after 48 weeks of treatment in subjects with spinocerebellar ataxia (SCA).
Inclusion Criteria:
1. Subjects with a known or suspected diagnosis of the following specific hereditary
ataxias: SCA1, SCA2, SCA3, SCA6, SCA7, SCA8 and SCA10;
1. A subject should have a confirmed genotypic diagnosis from a CLIA certified lab
(can produce test results); or,
2. A subject has a family member that has a confirmed genotypic diagnosis from a
CLIA certified lab (can produce test results) and must be willing to undergo
genetic testing to confirm underlying SCA diagnosis; or,
3. A subject has a confirmed genotypic diagnosis from a lab that is not CLIA
certified and must be willing to undergo genetic testing to confirm underlying
SCA diagnosis; or,
4. A subject has clinical evidence that supports diagnosis of one of the
aforementioned SCA genotypes but does not have producible test results from a
CLIA certified lab from either a family member or for his or herself and the
subject must be willing to undergo such testing to confirm the SCA diagnosis (in
this case, site must wait for results of genotypic testing prior to
randomization)
2. Ability to ambulate 8 meters without human assistance (canes and other devices
allowed)
3. Screening f-SARA total score ≥3;
4. Score of ≥1 on gait subsection of the f-SARA
5. Determined by the investigator to be medically stable at Baseline/randomization as
assessed by medical history, physical examination, laboratory test results, and
electrocardiogram testing.
Exclusion Criteria:
1. A ≥ 2-point difference on the Modified Functional SARA score between screening and
baseline
2. MMSE score <24
3. 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.
4. A prominent spasticity or dystonia that, in the opinion of the investigator, will
compromise the ability of the SARA instrument to assess underlying ataxia severity.
5. A score of 4 on any individual item (Items 1-4) of the f-SARA
6. Subjects should be excluded at screening or baseline if medical conditions have arisen
or there is a change in disease status that could confound the ability of the SARA to
accurately reflect changes in ataxia severity.
7. 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
5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Phone: 773-702-4610
University of Chicago One of the world's premier academic and research institutions, the University of...
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-5060
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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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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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12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
720-848-0000
Phone: 303-724-6351
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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2201 Inwood Rd
Dallas, Texas 75235
Dallas, Texas 75235
(214) 645-8300
Phone: 214-648-0212
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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4500 San Pablo Rd S
Jacksonville, Florida 32224
Jacksonville, Florida 32224
(904) 953-2000
Phone: 904-953-7229
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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