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

Axovant Sciences Ltd.56 sites in 7 countries240 target enrollmentOctober 2016

ConditionsDementia With Lewy Bodies

InterventionsRVT-101 35 mg RVT-101 70 mg

DrugsRVT-101 35 mg RVT-101 70 mg

Overview

Phase: Phase 2
Intervention: RVT-101 35 mg
Conditions: Dementia With Lewy Bodies
Sponsor: Axovant Sciences Ltd.
Enrollment: 240
Locations: 56
Primary Endpoint: Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2016

End Date

February 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Axovant Sciences Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participated in the lead-in study RVT-101-2001.

Exclusion Criteria

•Any clinically relevant concomitant disease, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.

Arms & Interventions

RVT-101 35 mg

RVT-101 35 mg once daily

Intervention: RVT-101 35 mg

RVT-101 70 mg

RVT-101 70 mg once daily

Intervention: RVT-101 70 mg

Outcomes

Primary Outcomes

Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments

Time Frame: 24 weeks