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

Phase 2

Terminated

• Conditions: Dementia With Lewy Bodies
• Interventions: Drug: RVT-101 35 mg; Drug: RVT-101 70 mg

• Registration Number: NCT02928445
• Lead Sponsor: Axovant Sciences Ltd.

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-10
• Status Verified: 2018-02
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RVT-101 35 mg	RVT-101 35 mg	RVT-101 35 mg once daily
RVT-101 70 mg	RVT-101 70 mg	RVT-101 70 mg once daily

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments	24 weeks

Trial Locations

Locations (56)

NE402; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

NE401; 🇳🇱 Den Bosch, Netherlands

UK808; 🇬🇧 Epping, Essex, United Kingdom

IT301; 🇮🇹 Milano, Italy

US138; 🇺🇸 Phoenix, Arizona, United States

US118; 🇺🇸 Indianapolis, Indiana, United States

US123; 🇺🇸 Washington, District of Columbia, United States

US104; 🇺🇸 Boca Raton, Florida, United States

US122; 🇺🇸 Orlando, Florida, United States

US130; 🇺🇸 Quincy, Massachusetts, United States

US139; 🇺🇸 Sun City, Arizona, United States

US125; 🇺🇸 Tucson, Arizona, United States

US108; 🇺🇸 Phoenix, Arizona, United States

US134; 🇺🇸 Oxnard, California, United States

US119; 🇺🇸 Orange, California, United States

US133; 🇺🇸 Rancho Mirage, California, United States

US140; 🇺🇸 Sacramento, California, United States

US137; 🇺🇸 Palm Beach Gardens, Florida, United States

US126; 🇺🇸 Tampa, Florida, United States

US136; 🇺🇸 Atlanta, Georgia, United States

US105; 🇺🇸 Lexington, Kentucky, United States

SP600; 🇪🇸 Barcelona, Spain

US102; 🇺🇸 Rochester, Minnesota, United States

US109; 🇺🇸 New York, New York, United States

US100; 🇺🇸 Chapel Hill, North Carolina, United States

US106; 🇺🇸 Columbus, Ohio, United States

US131; 🇺🇸 Portland, Oregon, United States

FR952; 🇫🇷 Toulouse, Haute-Garonne, France

FR951; 🇫🇷 Villeurbanne, Rhone, France

US101; 🇺🇸 Charlottesville, Virginia, United States

FR957; 🇫🇷 Lille, Nord, France

CA200; 🇨🇦 Toronto, Ontario, Canada

FR959; 🇫🇷 Paris, France

FR960; 🇫🇷 Paris, France

IT304; 🇮🇹 Tricase, Lecce, Italy

FR953; 🇫🇷 Saint-Herblain, France

FR950; 🇫🇷 Strasbourg, France

FR955; 🇫🇷 Vandœuvre-lès-Nancy, France

IT300; 🇮🇹 Genova, Liguria, Italy

IT302; 🇮🇹 Brescia, Lombardia, Italy

IT305; 🇮🇹 Venice, Italy

IT306; 🇮🇹 Brescia, Italy

UK801; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

SP605; 🇪🇸 Barcelona, Spain

UK804; 🇬🇧 Southampton, Hampshire, United Kingdom

UK807; 🇬🇧 Bristol, United Kingdom

UK806; 🇬🇧 Dundee, United Kingdom

UK805; 🇬🇧 Isleworth, United Kingdom

UK809; 🇬🇧 London, United Kingdom

UK800; 🇬🇧 London, United Kingdom

UK802; 🇬🇧 Manchester, United Kingdom

UK803; 🇬🇧 Newcastle upon Tyne, United Kingdom

US110; 🇺🇸 Cleveland, Ohio, United States

US141; 🇺🇸 Englewood, Colorado, United States

US111; 🇺🇸 Jacksonville, Florida, United States

US120; 🇺🇸 Willow Grove, Pennsylvania, United States