Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
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|ClinicalTrials.gov Identifier: NCT02669433|
Recruitment Status : Completed
First Posted : February 1, 2016
Results First Posted : April 26, 2019
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dementia With Lewy Bodies||Drug: RVT-101 35 mg Drug: RVT-101 70 mg Drug: Placebo||Phase 2|
The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a 24-week double-blind treatment period in patients with dementia with Lewy bodies.
The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo).
Subjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||484 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: RVT-101 35 mg
RVT-101 35 mg once daily
Drug: RVT-101 35 mg
once daily, oral, 35-mg tablets
Experimental: RVT-101 70 mg
RVT-101 70 mg once daily
Drug: RVT-101 70 mg
once daily, oral, 35-mg tablets
Placebo Comparator: Placebo
once daily, oral, matching tablets
- Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24 [ Time Frame: Change from Baseline at 24 weeks ]The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.
- Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24 [ Time Frame: Change from Baseline at 24 weeks ]The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.
- Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24 [ Time Frame: Change from Baseline at 24 weeks ]To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.
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): NCT02669433
|Study Director:||Ilise Lombardo, MD||Axovant Sciences Inc., Senior Vice President, Clinical Research|