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

April 4, 2019 updated by: Axovant Sciences Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

484

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • CA200
    • Quebec
      • Sherbrooke, Quebec, Canada, J1J 3H5
        • CA201
  • France
      • Bron, France, 69677
        • FR954
      • Paris, France, 75010
        • FR959
      • Paris, France, 75013
        • FR960
      • Paris, France, 75013
        • FR956
      • Saint Herblain, France, 44800
        • FR953
      • Strasbourg, France, 67000
        • FR950
      • Vandoeuvre les Nancy, France, 54500
        • FR955
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31052
        • FR952
    • Nord
      • Lille, Nord, France, 59037
        • FR957
    • Rhône
      • Villeurbanne, Rhône, France, 69100
        • FR951
  • Italy
      • Brescia, Italy, 25123
        • IT306
      • Milano, Italy, 20133
        • IT301
      • Venice, Italy, I-30126
        • IT305
    • Lecce
      • Tricase, Lecce, Italy, 73039
        • IT304
    • Liguria
      • Genova, Liguria, Italy, 16132
        • IT300
    • Lombardia
      • Brescia, Lombardia, Italy, 25125
        • IT302
  • Netherlands
      • Hertogenbosch, Netherlands, 5223 GZ
        • NE401
      • Rotterdam, Netherlands, 3015 CE
        • NE400
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • NE402
  • Spain
      • Barcelona, Spain, 08028
        • SP600
      • Barcelona, Spain, 08041
        • SP605
      • Burgos, Spain, 09006
        • SP602
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • UK807
      • Dundee, United Kingdom, DD1 9SY
        • UK806
      • Isleworth, United Kingdom, TW76FY
        • UK805
      • London, United Kingdom, SE5 8AF
        • UK800
      • London, United Kingdom, W1G 9RU
        • UK809
      • Manchester, United Kingdom, M8 5RB
        • UK802
      • Newcastle upon Tyne, United Kingdom, NE4 5PL
        • UK803
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB21 5EF
        • UK801
    • Essex
      • Epping, Essex, United Kingdom, CM16 6TN
        • UK808
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO30 3JB
        • UK804
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • US138
      • Phoenix, Arizona, United States, 85013
        • US108
      • Sun City, Arizona, United States, 85351
        • US139
      • Tucson, Arizona, United States, 85704
        • US125
    • California
      • Irvine, California, United States, 92868
        • US119
      • Oxnard, California, United States, 93030
        • US134
      • Rancho Mirage, California, United States, 92270
        • US133
      • Sacramento, California, United States, 95816
        • US140
    • Colorado
      • Englewood, Colorado, United States, 80113
        • US141
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • US123
    • Florida
      • Boca Raton, Florida, United States, 33431
        • US104
      • Boca Raton, Florida, United States, 33486
        • US116
      • Jacksonville, Florida, United States, 32224
        • US111
      • Orlando, Florida, United States, 32806
        • US122
      • Palm Beach Gardens, Florida, United States, 33410
        • US137
      • Tampa, Florida, United States, 33609
        • US126
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • US136
    • Illinois
      • Chicago, Illinois, United States, 60612
        • US112
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • US118
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • US105
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • US135
      • Quincy, Massachusetts, United States, 02196
        • US130
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • US102
    • New York
      • New York, New York, United States, 10032
        • US109
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • US100
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • US110
      • Columbus, Ohio, United States, 43210
        • US106
    • Oregon
      • Portland, Oregon, United States, 97210
        • US131
    • Pennsylvania
      • Willow Grove, Pennsylvania, United States, 19090
        • US120
    • Texas
      • Dallas, Texas, United States, 75390
        • US124
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • US101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
once daily, oral, matching tablets
EXPERIMENTAL: RVT-101 35 mg
RVT-101 35 mg once daily
Drug: RVT-101 35 mg
once daily, oral, 35-mg tablets
EXPERIMENTAL: RVT-101 70 mg
RVT-101 70 mg once daily
Drug: RVT-101 70 mg
once daily, oral, 35-mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24
Time Frame: Change from Baseline at 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24
Time Frame: Change from Baseline at 24 weeks
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
Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24
Time Frame: Change from Baseline at 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axovant Sciences Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (ESTIMATE)

February 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVT-101-2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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