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 : September 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|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 Drug: Placebo Comparator||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 in Adult Subjects With Spinocerebellar Ataxia|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||August 18, 2017|
|Estimated Study Completion Date :||October 2020|
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.
Loose filled capsule
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.
Drug: Placebo Comparator
BHV-4157 placebo-matching loose filled capsule
- 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. ]
- • 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 learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960893