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

NCT02928445 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-04-18

No results posted yet for this study

Summary

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.

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

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
86 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

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

Study Locations

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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 NCT02928445 on ClinicalTrials.gov