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NCT02669433 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Axovant Sciences.

Completed
Registry status
Phase 2
Development phase
484
Enrollment target

NCT02669433: Completed Phase 2 study, sponsored by Axovant Sciences.

NCT02669433 is a Phase 2 study that has completed, run by Axovant Sciences. The registered enrollment target is 484 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (264% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02669433, a Phase 2 study, has completed, sponsored by Axovant Sciences.

COMPLETED
Registry status
Phase 2
Development phase
484 participants
Enrollment target

Study Summary

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

Primary Outcome

The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.

Interventions

  • DRUG Placebo
  • DRUG RVT-101 35 mg
  • DRUG RVT-101 70 mg

Trial Details

FieldValue
Enrollment Target 484 participants
Start Date 2016-01
Est. Completion 2017-12
Phase Phase 2
Axovant Sciences

8 total trials

What the finished NCT02669433 record still lists

NCT02669433 is an interventional study that assigns participants to a tested intervention. The registered 484 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (264% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT02669433 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02669433 about?

NCT02669433 is a clinical study titled "Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study". This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.

What is the current status of trial NCT02669433?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 484 participants. The study started on 2016-01. Estimated completion is 2017-12.

What interventions are being tested in trial NCT02669433?

The interventions under investigation include: Placebo (DRUG), RVT-101 35 mg (DRUG), RVT-101 70 mg (DRUG).

Who is sponsoring clinical trial NCT02669433?

This trial is sponsored by Axovant Sciences, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02669433's enrollment target sits among peer trials

484 76th of 2000 higher than 1,925 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02669433, the US trial registry maintained by the National Library of Medicine. NCT02669433 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.