Phase
Condition
Spinocerebellar Disorders
Friedreich's Ataxia
Dyskinesias
Treatment
Placebo
troriluzole
Placebos
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with a known or suspected diagnosis of the following specifichereditary ataxias: SCA1, SCA2, SCA3, SCA6, SCA7, SCA8 and SCA10.
A participant should have a confirmed genotypic diagnosis from a ClinicalLaboratory Improvement Amendments (CLIA) certified lab (can produce testresults); or,
A participant has a family member that has a confirmed genotypic diagnosis froma CLIA certified lab (can produce test results) and must be willing to undergogenetic testing to confirm underlying SCA diagnosis; or,
A participant has a confirmed genotypic diagnosis from a lab that is not CLIAcertified and must be willing to undergo genetic testing to confirm underlyingSCA diagnosis; or,
A participant has clinical evidence that supports diagnosis of one of theaforementioned SCA genotypes but does not have producible test results from aCLIA certified lab from either a family member or for his or herself and theparticipant must be willing to undergo such testing to confirm the SCAdiagnosis (in this case, site must wait for results of genotypic testing priorto randomization)
Ability to ambulate 8 meters without human assistance (canes and other devicesallowed)
Screening Modified Functional Scale for the Assessment and Rating of Ataxia (f-SARA)total score ≥3.
Score of ≥1 on gait subsection of the f-SARA
Determined by the investigator to be medically stable at Baseline/randomization asassessed by medical history, physical examination, laboratory test results, andelectrocardiogram testing.
Exclusion
Exclusion Criteria:
A ≥ 2-point difference on the Modified Functional SARA score between screening andbaseline
Mini Mental State Exam (MMSE) score <24
Any medical condition other than one of the hereditary ataxias specified in theinclusion criteria that could predominantly explain or contribute significantly tothe participants' symptoms of ataxia.
A prominent spasticity or dystonia that, in the opinion of the investigator, willcompromise the ability of the SARA instrument to assess underlying ataxia severity.
A score of 4 on any individual item (Items 1-4) of the f-SARA
Participants should be excluded at screening or baseline if medical conditions havearisen or there is a change in disease status that could confound the ability of theSARA to accurately reflect changes in ataxia severity.
Active liver disease or a history of hepatic intolerance to medications that in theinvestigator's judgment, is medically significant.
Study Design
Connect with a study center
Central South University Xiangya Hospital
Changsha, Hunan 410008
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
Barrow Neurological Institute
Phoenix, Arizona 85013
United StatesSite Not Available
CNS Trials
Long Beach, California 90806
United StatesSite Not Available
UCLA
Los Angeles, California 90095
United StatesSite Not Available
UCSF
San Francisco, California 94158
United StatesSite Not Available
University of Colorado Hospital
Aurora, Colorado 80045
United StatesSite Not Available
University of Florida Health
Gainesville, Florida 32610
United StatesSite Not Available
Mayo Clinic Florida
Jacksonville, Florida 32224
United StatesSite Not Available
University of South Florida
Tampa, Florida 33612
United StatesSite Not Available
Emory
Atlanta, Georgia 30329
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Northwest Neurology, Ltd.
Lake Barrington, Illinois 60010
United StatesSite Not Available
Northwest Neurology, Ltd.
Rolling Meadows, Illinois 60008
United StatesSite Not Available
Johns Hopkins Medicine
Lutherville, Maryland 21093
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Columbia University
New York, New York 10032
United StatesSite Not Available
Duke University Movement Disorders Clinic
Durham, North Carolina 27705
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75390-9036
United StatesSite Not Available
Houston Methodist
Houston, Texas 77030
United StatesSite Not Available
Swedish Health Services
Seattle, Washington 98122
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.