drugset / Trial / NCT02669433
Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.
Timeline
- Start
- 2016-01
- Primary completion
- 2017-12
- Completion
- 2017-12
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs RVT-101 35 mg; p = 0.158; NCT02669433 ↗
registry analysis (superiority test); Placebo vs RVT-101 70 mg; p = 0.6069; NCT02669433 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | intepirdine | Small molecule | 35 mg | Oral |
| Subject | intepirdine | Small molecule | 70 mg | Oral |