ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial in Adult Subjects With Spinocerebellar Ataxia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02960893
Recruitment Status : Active, not recruiting
First Posted : November 10, 2016
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Cognitive Research Corporation
Cytel Inc.
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

November 4, 2016
November 10, 2016
August 8, 2018
December 2016
August 18, 2017   (Final data collection date for primary outcome measure)
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. ]
Same as current
Complete list of historical versions of study NCT02960893 on ClinicalTrials.gov Archive Site
  • • To assess the safety and tolerability of BHV-4157 in subjects with SCA by measuring the frequency and severity of adverse events and discontinuations of adverse events. [ Time Frame: Baseline to week 8. ]
    Measured by the frequency and severity of adverse events and discontinuations of adverse events.
  • To compare efficacy of BHV-4157 with placebo on patient impression of benefit via use of the PGI-C [ Time Frame: Baseline to Week 8 ]
    Change in PGI-C score
To measure the total time of the 8 Meter Walk [ Time Frame: The change in total time from baseline to week 8. ]
Not Provided
Not Provided
 
Trial in Adult Subjects With Spinocerebellar Ataxia
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).
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Spinocerebellar Ataxias
  • Spinocerebellar Ataxia Genotype Type 1
  • Spinocerebellar Ataxia Genotype Type 2
  • Spinocerebellar Ataxia Genotype Type 3
  • Spinocerebellar Ataxia Genotype Type 6
  • Spinocerebellar Ataxia Genotype Type 7
  • Spinocerebellar Ataxia Genotype Type 8
  • Spinocerebellar Ataxia Genotype Type 10
  • Drug: BHV-4157
    Loose filled capsule
  • Drug: Placebo Comparator
    BHV-4157 placebo-matching loose filled capsule
  • Experimental: BHV-4157
    Participants orally receive once daily (QD) dose of BHV-4157 140 milligram (mg) provided as a loose filled capsule in the morning, without regard to meals for 8 weeks. Participants who do not tolerate their treatment switch to night time dosing if there is reason to believe that may help tolerability. In addition, the investigator may permit up to one week of every other day dosing prior to re-instituting daily dosing.
    Intervention: Drug: BHV-4157
  • Placebo Comparator: Placebo Comparator
    Participants orally receive QD dose of BHV-4157 placebo-matching capsules provided as a loose filled capsule in the morning, without regard to meals for 8 weeks. Participants who do not tolerate their treatment switch to night time dosing if there is reason to believe that may help tolerability. In addition, the investigator may permit up to one week of every other day dosing prior to re-instituting daily dosing.
    Intervention: Drug: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
141
120
August 2019
August 18, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02960893
BHV4157-201
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Biohaven Pharmaceuticals, Inc.
Biohaven Pharmaceuticals, Inc.
  • Cognitive Research Corporation
  • Cytel Inc.
Not Provided
Biohaven Pharmaceuticals, Inc.
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP