← Trials/Trial dossier/NCT02928445

TerminatedPhase 2 / PHASE3

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

A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)

Lead sponsor

Axovant Sciences Ltd.

Asset

Intepirdine

Listed sites

Recruiting sites

Enrollment

240

estimated

Study population

Lewy body dementia

Key I/E criterion

•Age 50-86

Primary endpoint

•Adverse events and changes in physical examinations, vital sign measurements

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02928445

Org study IDRVT-101-2002

Timeline

Milestones

Study start2016-10actual (month precision)

Study first posted2016-10-10estimated

Primary completion2018-02actual (month precision)

Study completion2018-02actual (month precision)

Last update posted2018-04-18actual

Assets

Drug assets

Intepirdine

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age86 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participated in the lead-in study RVT-101-2001

Exclusion criteria

•Any clinically relevant concomitant disease, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments

Time frame:24 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.