NCT02669433

Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study

A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 484 (actual)
• Sponsor: Axovant Sciences Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.

Detailed description

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).

Conditions

• Dementia With Lewy Bodies

Interventions

Type	Name	Description
DRUG	RVT-101 35 mg	once daily, oral, 35-mg tablets
DRUG	RVT-101 70 mg	once daily, oral, 35-mg tablets
DRUG	Placebo	once daily, oral, matching tablets

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-02-01
• Last updated: 2019-04-26
• Results posted: 2019-04-26

Locations

65 sites across 7 countries: United States, Canada, France, Italy, Netherlands, Spain, United Kingdom