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Trial record 16 of 17 for:    sca3

Trial in Adult Subjects With Spinocerebellar Ataxia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Biohaven Pharmaceutical Holding Company Ltd.
Sponsor:
Collaborators:
Cognitive Research Corporation
Cytel Inc.
Information provided by (Responsible Party):
Biohaven Pharmaceutical Holding Company Ltd.
ClinicalTrials.gov Identifier:
NCT02960893
First received: November 4, 2016
Last updated: March 8, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to compare the efficacy of BHV-4157 versus placebo on ataxia symptoms in subjects with spinocerebellar ataxia (SCA).

Condition Intervention Phase
Spinocerebellar Ataxias
Spinocerebellar Ataxia Type 1
Spinocerebellar Ataxia Type 2
Spinocerebellar Ataxia Type 3
Spinocerebellar Ataxia Type 6
Spinocerebellar Ataxia Type 7
Spinocerebellar Ataxia Type 8
Spinocerebellar Ataxia Type 10
Drug: BHV-4157
Drug: Placebo Comparator
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 in Adult Subjects With Spinocerebellar Ataxia

Resource links provided by NLM:


Further study details as provided by Biohaven Pharmaceutical Holding Company Ltd.:

Primary Outcome Measures:
  • To measure the change in total score on the Scale for Assessment and Rating of Ataxia (SARA) [ Time Frame: The change in total score from baseline to week 8. ]

Secondary Outcome Measures:
  • To measure the total time of the 8 Meter Walk [ Time Frame: The change in total time from baseline to week 8. ]

Estimated Enrollment: 120
Study Start Date: December 2016
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BHV-4157
140 mg QD
Drug: BHV-4157
140mg capsule QD
Placebo Comparator: Placebo Comparator
matching placebo capsule QD
Drug: Placebo Comparator

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02960893

Locations
United States, California
CNS Trial Recruiting
Long Beach, California, United States, 90806
Contact: Julie Nguyen    562-304-1742    julienguyen@cnstrial.com   
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Aaron Fisher    310-206-8153    adfisher@mednet.ucla.edu   
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Alayna Liptak    415-502-7640    Alayna.Liptak@ucsf.edu   
United States, Colorado
University of Colorado Denver Recruiting
Denver, Colorado, United States, 80045
Contact: Mary Cook    303-724-7968    MARY.M.COOK@UCDENVER.EDU   
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Teri Green    352-273-9528    teri.green@neurology.ufl.edu   
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Mary Freeman    813-974-5909    mfreema4@health.usf.edu   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Rebecca McMurray    404-712-7013    rmcmurr@emory.edu   
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Karen Williams    312-503-2068    k-williams8@northwestern.edu   
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Victoria Staszak    773-702-5545    vstaszak@neurology.bsd.uchicago.edu   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Donna DeLeno Neuworth    410-616-2811    Ddeleno1@jhmi.edu   
United States, Massachusetts
Harvard University (Massachusetts General Hospital) Recruiting
Boston, Massachusetts, United States, 02114
Contact: Samantha Pierce    617-726-4961    Spierce0@mgh.harvard.edu   
Harvard University (Beth Israel Deaconess Medical Center) Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Eden Park    617-667-0453    epark6@bidmc.harvard.edu   
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Elizabeth Sullivan    734-232-6247    elizsull@umich.edu   
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Darya Tomishon    212-305-5779    dvt2101@cumc.columbia.edu   
United States, Texas
University of Texas Southwestern Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Ashley Gerald    214-648-0212    ashley.gerald@utsouthwestern.edu   
Houston Methodist Research Center Recruiting
Houston, Texas, United States, 77030
Contact: Chia Arif    713-363-8390    carif@houstonmethodist.org   
Sponsors and Collaborators
Biohaven Pharmaceutical Holding Company Ltd.
Cognitive Research Corporation
Cytel Inc.
  More Information

Responsible Party: Biohaven Pharmaceutical Holding Company Ltd.
ClinicalTrials.gov Identifier: NCT02960893     History of Changes
Other Study ID Numbers: BHV4157-201
Study First Received: November 4, 2016
Last Updated: March 8, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Biohaven Pharmaceutical Holding Company Ltd.:
Ataxia
SCA
Spinocerebellar Ataxia

Additional relevant MeSH terms:
Machado-Joseph Disease
Ataxia
Cerebellar Ataxia
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on March 29, 2017