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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02669433
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : January 18, 2018
Information provided by (Responsible Party):
Axovant Sciences Ltd.

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

Condition or disease Intervention/treatment Phase
Dementia With Lewy Bodies Drug: RVT-101 35 mg Drug: RVT-101 70 mg Drug: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
Actual Study Start Date : January 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

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

Placebo Comparator: Placebo
Drug: Placebo
once daily, oral, matching tablets

Primary Outcome Measures :
  1. Change from baseline on Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change from baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 items (ADAS-Cog-11) [ Time Frame: 24 weeks ]
  2. Change from baseline Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) [ Time Frame: 24 weeks ]
  3. Occurrence of reported adverse events and findings noted by investigators on clinical examination, electrocardiograms, and routine laboratory assessments [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02669433

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Sponsors and Collaborators
Axovant Sciences Ltd.
Study Director: Ilise Lombardo, MD Axovant Sciences Inc., Senior Vice President, Clinical Research

Responsible Party: Axovant Sciences Ltd. Identifier: NCT02669433     History of Changes
Other Study ID Numbers: RVT-101-2001
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by Axovant Sciences Ltd.:
Dementia with Lewy bodies
Lewy bodies

Additional relevant MeSH terms:
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases