Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study

Dementia With Lewy Bodies Clinical Trial

Official title:

A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669433
• Other study ID #: RVT-101-2001
• Status: Completed
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2019
• Source: Axovant Sciences Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.

Description:

The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a 24-week double-blind treatment period in patients with dementia with Lewy bodies.

The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo).

Subjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male or female subject with probable DLB

• Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline

• Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator

• Patient has a reliable caregiver who is willing to report on the subject's status throughout the study

• Patients currently receiving therapy for DLB are eligible for enrollment

Exclusion Criteria:

• Atypical clinical features or clinical course that would lead the investigator to conclude primary symptoms are more likely explained by an alternate dementia diagnosis.

• Any clinically relevant concomitant disease that, in the opinion of the investigator, makes the patient 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
• Placebo
once daily, oral, matching tablets

Locations

Country	Name	City	State
Canada	CA201	Sherbrooke	Quebec
Canada	CA200	Toronto	Ontario
France	FR954	Bron
France	FR957	Lille	Nord
France	FR956	Paris
France	FR959	Paris
France	FR960	Paris
France	FR953	Saint Herblain
France	FR950	Strasbourg
France	FR952	Toulouse	Haute-Garonne
France	FR955	Vandoeuvre les Nancy
France	FR951	Villeurbanne	Rhône
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	Hertogenbosch
Netherlands	NE400	Rotterdam
Spain	SP600	Barcelona
Spain	SP605	Barcelona
Spain	SP602	Burgos
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	US116	Boca Raton	Florida
United States	US100	Chapel Hill	North Carolina
United States	US101	Charlottesville	Virginia
United States	US112	Chicago	Illinois
United States	US110	Cleveland	Ohio
United States	US106	Columbus	Ohio
United States	US124	Dallas	Texas
United States	US141	Englewood	Colorado
United States	US118	Indianapolis	Indiana
United States	US119	Irvine	California
United States	US111	Jacksonville	Florida
United States	US105	Lexington	Kentucky
United States	US109	New York	New York
United States	US135	Newton	Massachusetts
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	Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24	The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.	Change from Baseline at 24 weeks
Secondary	Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24	The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.	Change from Baseline at 24 weeks
Secondary	Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24	To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.	Change from Baseline at 24 weeks