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Trial record 16 of 18 for:    sca3

Trial in Adult Subjects With Spinocerebellar Ataxia

This study is ongoing, but not recruiting participants.
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: June 15, 2017
Last verified: June 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: Quadruple (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, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
CNS Trial
Long Beach, California, United States, 90806
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94158
United States, Colorado
University of Colorado Denver
Denver, Colorado, United States, 80045
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
University of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Harvard University (Massachusetts General Hospital)
Boston, Massachusetts, United States, 02114
Harvard University (Beth Israel Deaconess Medical Center)
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
United States, New York
Columbia University
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Houston Methodist Research Center
Houston, Texas, United States, 77030
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: June 15, 2017
Individual Participant Data (IPD) Sharing Statement:
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 August 18, 2017