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

Dementia With Lewy Bodies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02928445
• Other study ID #: RVT-101-2002
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: October 7, 2016
• Last updated: April 17, 2018
• Start date: October 2016
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: Axovant Sciences Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 240
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 86 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Dementia With Lewy Bodies
• Lewy Body Disease

Intervention

Drug:
• RVT-101 35 mg
once daily, oral, 35-mg tablets
• RVT-101 70 mg
once daily, oral, 35-mg tablets

Locations

Country	Name	City	State
Canada	CA200	Toronto	Ontario
France	FR957	Lille	Nord
France	FR959	Paris
France	FR960	Paris
France	FR953	Saint-Herblain
France	FR950	Strasbourg
France	FR952	Toulouse	Haute-Garonne
France	FR955	Vandœuvre-lès-Nancy
France	FR951	Villeurbanne	Rhone
Italy	IT302	Brescia	Lombardia
Italy	IT306	Brescia
Italy	IT300	Genova	Liguria
Italy	IT301	Milano
Italy	IT304	Tricase	Lecce
Italy	IT305	Venice
Netherlands	NE402	Amsterdam	Noord-Holland
Netherlands	NE401	Den Bosch
Spain	SP600	Barcelona
Spain	SP605	Barcelona
United Kingdom	UK807	Bristol
United Kingdom	UK801	Cambridge	Cambridgeshire
United Kingdom	UK806	Dundee
United Kingdom	UK808	Epping	Essex
United Kingdom	UK805	Isleworth
United Kingdom	UK800	London
United Kingdom	UK809	London
United Kingdom	UK802	Manchester
United Kingdom	UK803	Newcastle upon Tyne
United Kingdom	UK804	Southampton	Hampshire
United States	US136	Atlanta	Georgia
United States	US104	Boca Raton	Florida
United States	US100	Chapel Hill	North Carolina
United States	US101	Charlottesville	Virginia
United States	US110	Cleveland	Ohio
United States	US106	Columbus	Ohio
United States	US141	Englewood	Colorado
United States	US118	Indianapolis	Indiana
United States	US111	Jacksonville	Florida
United States	US105	Lexington	Kentucky
United States	US109	New York	New York
United States	US119	Orange	California
United States	US122	Orlando	Florida
United States	US134	Oxnard	California
United States	US137	Palm Beach Gardens	Florida
United States	US108	Phoenix	Arizona
United States	US138	Phoenix	Arizona
United States	US131	Portland	Oregon
United States	US130	Quincy	Massachusetts
United States	US133	Rancho Mirage	California
United States	US102	Rochester	Minnesota
United States	US140	Sacramento	California
United States	US139	Sun City	Arizona
United States	US126	Tampa	Florida
United States	US125	Tucson	Arizona
United States	US123	Washington	District of Columbia
United States	US120	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Axovant Sciences Ltd.

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments		24 weeks