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

NCT02669433 | Completed Phase 2 Results DMC

• 1 other identifier: RVT-101-2001
• Study Type: interventional
• Target: 484
• Locations: 7 countries
• Sites: 65

Brief Summary

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

Conditions

Dementia With Lewy Bodies

Keywords

Dementia with Lewy bodies; Lewy bodies; intepirdine; RVT-101; dementia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24

  Change from Baseline at 24 weeks

• Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24

  Change from Baseline at 24 weeks

Study Arms (3)

RVT-101 35 mg

EXPERIMENTAL

RVT-101 35 mg once daily

Drug: RVT-101 35 mg

RVT-101 70 mg

EXPERIMENTAL

RVT-101 70 mg once daily

Drug: RVT-101 70 mg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

RVT-101 35 mg DRUG

once daily, oral, 35-mg tablets

RVT-101 35 mg

RVT-101 70 mg DRUG

once daily, oral, 35-mg tablets

RVT-101 70 mg

Placebo DRUG

once daily, oral, matching tablets

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Axovant Sciences Ltd.: lead

Study Sites (65)

US138

Phoenix, Arizona, 85006, United States

Location

US108

Phoenix, Arizona, 85013, United States

Location

US139

Sun City, Arizona, 85351, United States

Location

US125

Tucson, Arizona, 85704, United States

Location

US119

Irvine, California, 92868, United States

Location

US134

Oxnard, California, 93030, United States

Location

US133

Rancho Mirage, California, 92270, United States

Location

US140

Sacramento, California, 95816, United States

Location

US141

Englewood, Colorado, 80113, United States

Location

US123

Washington D.C., District of Columbia, 20007, United States

Location

US104

Boca Raton, Florida, 33431, United States

Location

US116

Boca Raton, Florida, 33486, United States

Location

US111

Jacksonville, Florida, 32224, United States

Location

US122

Orlando, Florida, 32806, United States

Location

US137

Palm Beach Gardens, Florida, 33410, United States

Location

US126

Tampa, Florida, 33609, United States

Location

US136

Atlanta, Georgia, 30331, United States

Location

US112

Chicago, Illinois, 60612, United States

Location

US118

Indianapolis, Indiana, 46202, United States

Location

US105

Lexington, Kentucky, 40536, United States

Location

US135

Newton, Massachusetts, 02459, United States

Location

US130

Quincy, Massachusetts, 02196, United States

Location

US102

Rochester, Minnesota, 55905, United States

Location

US109

New York, New York, 10032, United States

Location

US100

Chapel Hill, North Carolina, 27514, United States

Location

US110

Cleveland, Ohio, 44195, United States

Location

US106

Columbus, Ohio, 43210, United States

Location

US131

Portland, Oregon, 97210, United States

Location

US120

Willow Grove, Pennsylvania, 19090, United States

Location

US124

Dallas, Texas, 75390, United States

Location

US101

Charlottesville, Virginia, 22908, United States

Location

CA200

Toronto, Ontario, M4N 3M5, Canada

Location

CA201

Sherbrooke, Quebec, J1J 3H5, Canada

Location

FR952

Toulouse, Haute-Garonne, 31052, France

Location

FR957

Lille, Nord, 59037, France

Location

FR951

Villeurbanne, Rhône, 69100, France

Location

FR954

Bron, 69677, France

Location

FR959

Paris, 75010, France

Location

FR956

Paris, 75013, France

Location

FR960

Paris, 75013, France

Location

FR953

Saint-Herblain, 44800, France

Location

FR950

Strasbourg, 67000, France

Location

FR955

Vandœuvre-lès-Nancy, 54500, France

Location

IT304

Tricase, Lecce, 73039, Italy

Location

IT300

Genoa, Liguria, 16132, Italy

Location

IT302

Brescia, Lombardy, 25125, Italy

Location

IT306

Brescia, 25123, Italy

Location

IT301

Milan, 20133, Italy

Location

IT305

Venice, I-30126, Italy

Location

NE402

Amsterdam, North Holland, 1081 HV, Netherlands

Location

NE401

's-Hertogenbosch, 5223 GZ, Netherlands

Location

NE400

Rotterdam, 3015 CE, Netherlands

Location

SP600

Barcelona, 08028, Spain

Location

SP605

Barcelona, 08041, Spain

Location

SP602

Burgos, 09006, Spain

Location

UK801

Cambridge, Cambridgeshire, CB21 5EF, United Kingdom

Location

UK808

Epping, Essex, CM16 6TN, United Kingdom

Location

UK804

Southampton, Hampshire, SO30 3JB, United Kingdom

Location

UK807

Bristol, BS10 5NB, United Kingdom

Location

UK806

Dundee, DD1 9SY, United Kingdom

Location

UK805

Isleworth, TW76FY, United Kingdom

Location

UK800

London, SE5 8AF, United Kingdom

Location

UK809

London, W1G 9RU, United Kingdom

Location

UK802

Manchester, M8 5RB, United Kingdom

Location

UK803

Newcastle upon Tyne, NE4 5PL, United Kingdom

Location

MeSH Terms

Conditions

Lewy Body Disease; Dementia

Interventions

3-benzenesulfonyl-8-piperazin-1-ylquinoline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Ilise Lombardo, MD
• Organization: Axovant Sciences, Inc.

ilise.lombardo@axovant.com

646-822-8626

Study Officials

• Ilise Lombardo, MD

  Axovant Sciences Inc., Senior Vice President, Clinical Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 1, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 26, 2019
• Results First Posted: April 26, 2019

Record last verified: 2019-04

Locations

ES (3); GB (10); FR (10); IT (6); NL (3); US (31); CA (2)