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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02669433
First Posted: February 1, 2016
Last Update Posted: September 28, 2017
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.
Information provided by (Responsible Party):
Axovant Sciences Ltd.
  Purpose
This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.

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

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Axovant Sciences Ltd.:

Primary Outcome Measures:
  • Change from baseline on Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) [ Time Frame: 24 weeks ]
  • Change from baseline on a computerized cognitive battery [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Change from baseline on a clinical assessment of visual hallucinations [ Time Frame: up to 24 weeks ]
  • Occurrence of reported adverse events and findings noted by investigators on clinical examination, electrocardiograms, and routine laboratory assessments [ Time Frame: 24 weeks ]

Enrollment: 240
Actual Study Start Date: January 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
Drug: Placebo
once daily, oral, matching tablets

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02669433


  Show 65 Study Locations
Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
Study Director: Ilise Lombardo, MD Axovant Sciences Inc., Senior Vice President, Clinical Research
  More Information

Additional Information:
Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02669433     History of Changes
Other Study ID Numbers: RVT-101-2001
First Submitted: January 25, 2016
First Posted: February 1, 2016
Last Update Posted: September 28, 2017
Last Verified: September 2017

Keywords provided by Axovant Sciences Ltd.:
Dementia with Lewy bodies
Lewy bodies
intepirdine
RVT-101
dementia

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