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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
484

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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