Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT02669433
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2016-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
Sponsor:
Axovant Sciences Ltd.
Organization:
Study Overview
Official Title:
A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.
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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: