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

April 17, 2018 updated by: Axovant Sciences Ltd.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 2
  • Phase 3

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
  • France
      • Paris, France, 75010
        • FR959
      • Paris, France, 75013
        • FR960
      • Saint-Herblain, France, 44800
        • FR953
      • Strasbourg, France, 67000
        • FR950
      • Vandœuvre-lès-Nancy, France, 54500
        • FR955
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31052
        • FR952
    • Nord
      • Lille, Nord, France, 59037
        • FR957
    • Rhone
      • Villeurbanne, Rhone, 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
      • Den Bosch, Netherlands, 5223 GZ
        • NE401
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • NE402
  • Spain
      • Barcelona, Spain, 08028
        • SP600
      • Barcelona, Spain, 08041
        • SP605
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • UK807
      • Dundee, United Kingdom, DD1 9SY
        • UK806
      • Isleworth, United Kingdom, TW7 6FY
        • 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
      • Orange, 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
      • 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
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • US118
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • US105
    • Massachusetts
      • 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
    • 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

48 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Time Frame
Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments
Time Frame: 24 weeks
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)

October 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

October 7, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 10, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVT-101-2002

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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