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

Axovant Sciences

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Dementia With Lewy Bodies

Treatments: Drug: RVT-101 70 mg; Drug: RVT-101 35 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02928445

RVT-101-2002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 50 to 86 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups

RVT-101 35 mg

Experimental group

Description:

RVT-101 35 mg once daily

Treatment:

Drug: RVT-101 35 mg

RVT-101 70 mg

Experimental group

Description:

RVT-101 70 mg once daily

Treatment:

Drug: RVT-101 70 mg