NCT02928445

Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension

A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Axovant Sciences Ltd. · Industry
• Sex: All
• Age: 50 Years – 86 Years
• Healthy volunteers: Not accepted

Summary

This 6-month extension study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) in subjects with Dementia with Lewy bodies (DLB) who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001.

Detailed description

This 6-month, double-blind,extension study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) in subjects with DLB who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001. The study duration for subjects in study centers in the USA will be 12 months. Subjects who were randomized to the RVT-101 35-mg and RVT-101 70-mg treatment groups in lead-in study RVT-101-2001 will remain in the same treatment groups for this study; subjects who were randomized to the placebo treatment group in the lead-in study will be assigned to the RVT-101 70-mg treatment group in this study. Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.

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

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2016-10-10
• Last updated: 2018-04-18

Locations

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