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

NCT02669433 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2019-04-26

Study results available
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Summary

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

Conditions

  • Dementia With Lewy Bodies

Interventions

DRUG

RVT-101 35 mg

once daily, oral, 35-mg tablets

DRUG

RVT-101 70 mg

once daily, oral, 35-mg tablets

DRUG

Placebo

once daily, oral, matching tablets

Sponsors & Collaborators

  • Axovant Sciences Ltd.

    lead INDUSTRY

Principal Investigators

  • Ilise Lombardo, MD · Axovant Sciences Inc., Senior Vice President, Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States
  • Canada
  • France
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02669433 on ClinicalTrials.gov