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

Last updated: April 4, 2019
Sponsor: Axovant Sciences Ltd.
Overall Status: Completed

Phase

2

Condition

Dementia

Lewy Body Dementia

Parkinson's Disease

Treatment

N/A

Clinical Study ID

NCT02669433
RVT-101-2001
  • Ages 50-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female subject with probable DLB

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

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

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

  • Patients currently receiving therapy for DLB are eligible for enrollment

Exclusion

Exclusion Criteria:

  • Atypical clinical features or clinical course that would lead the investigator toconclude primary symptoms are more likely explained by an alternate dementiadiagnosis.

  • Any clinically relevant concomitant disease that, in the opinion of the investigator,makes the patient unsuitable for inclusion in the study.

Study Design

Total Participants: 484
Study Start date:
January 01, 2016
Estimated Completion Date:
December 31, 2017

Study 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).

Connect with a study center

  • CA200

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • CA201

    Sherbrooke, Quebec J1J 3H5
    Canada

    Site Not Available

  • FR952

    Toulouse, Haute-Garonne 31052
    France

    Site Not Available

  • FR957

    Lille, Nord 59037
    France

    Site Not Available

  • FR951

    Villeurbanne, Rhône 69100
    France

    Site Not Available

  • FR954

    Bron, 69677
    France

    Site Not Available

  • FR956

    Paris, 75013
    France

    Site Not Available

  • FR959

    Paris, 75010
    France

    Site Not Available

  • FR960

    Paris, 75013
    France

    Site Not Available

  • FR953

    Saint Herblain, 44800
    France

    Site Not Available

  • FR950

    Strasbourg, 67000
    France

    Site Not Available

  • FR955

    Vandoeuvre les Nancy, 54500
    France

    Site Not Available

  • IT304

    Tricase, Lecce 73039
    Italy

    Site Not Available

  • IT300

    Genova, Liguria 16132
    Italy

    Site Not Available

  • IT302

    Brescia, Lombardia 25125
    Italy

    Site Not Available

  • IT306

    Brescia, 25123
    Italy

    Site Not Available

  • IT301

    Milano, 20133
    Italy

    Site Not Available

  • IT305

    Venice, I-30126
    Italy

    Site Not Available

  • NE402

    Amsterdam, Noord-Holland 1081 HV
    Netherlands

    Site Not Available

  • NE401

    Den Bosch, 5223 GZ
    Netherlands

    Site Not Available

  • NE401

    Hertogenbosch, 5223 GZ
    Netherlands

    Site Not Available

  • NE400

    Rotterdam, 3015 CE
    Netherlands

    Site Not Available

  • SP600

    Barcelona, 08028
    Spain

    Site Not Available

  • SP605

    Barcelona, 08041
    Spain

    Site Not Available

  • SP602

    Burgos, 09006
    Spain

    Site Not Available

  • UK801

    Cambridge, Cambridgeshire CB21 5EF
    United Kingdom

    Site Not Available

  • UK808

    Epping, Essex CM16 6TN
    United Kingdom

    Site Not Available

  • UK804

    Southampton, Hampshire SO30 3JB
    United Kingdom

    Site Not Available

  • UK807

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • UK806

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • UK805

    Isleworth, TW76FY
    United Kingdom

    Site Not Available

  • UK800

    London, SE5 8AF
    United Kingdom

    Site Not Available

  • UK809

    London, W1G 9RU
    United Kingdom

    Site Not Available

  • UK802

    Manchester, M8 5RB
    United Kingdom

    Site Not Available

  • UK803

    Newcastle upon Tyne, NE4 5PL
    United Kingdom

    Site Not Available

  • US108

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • US138

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • US139

    Sun City, Arizona 85351
    United States

    Site Not Available

  • US125

    Tucson, Arizona 85704
    United States

    Site Not Available

  • US119

    Irvine, California 92868
    United States

    Site Not Available

  • US119

    Orange County, California 92868
    United States

    Site Not Available

  • US134

    Oxnard, California 93030
    United States

    Site Not Available

  • US133

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • US140

    Sacramento, California 95816
    United States

    Site Not Available

  • US141

    Englewood, Colorado 80113
    United States

    Site Not Available

  • US123

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • US123

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

    Site Not Available

  • US104

    Boca Raton, Florida 33431
    United States

    Site Not Available

  • US116

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • US111

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • US122

    Orlando, Florida 32806
    United States

    Site Not Available

  • US137

    Palm Beach Gardens, Florida 33410
    United States

    Site Not Available

  • US126

    Tampa, Florida 33609
    United States

    Site Not Available

  • US136

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • US112

    Chicago, Illinois 60612
    United States

    Site Not Available

  • US118

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • US105

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • US135

    Newton, Massachusetts 02459
    United States

    Site Not Available

  • US130

    Quincy, Massachusetts 02196
    United States

    Site Not Available

  • US102

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • US109

    New York, New York 10032
    United States

    Site Not Available

  • US100

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • US132

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • US110

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • US106

    Columbus, Ohio 43210
    United States

    Site Not Available

  • US131

    Portland, Oregon 97210
    United States

    Site Not Available

  • US107

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • US120

    Willow Grove, Pennsylvania 19090
    United States

    Site Not Available

  • US124

    Dallas, Texas 75390
    United States

    Site Not Available

  • US101

    Charlottesville, Virginia 22908
    United States

    Site Not Available

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