Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03821402 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity
A Phase 2 study, sponsored by Revance Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
NCT03821402 is a Phase 2 study that has completed, run by Revance Therapeutics. The registered enrollment target is 83 participants.
The verdict
NCT03821402, a Phase 2 study, has completed, sponsored by Revance Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
Study Summary
This is a randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury. The study will be conducted in the U.S.A., approximately 128 adult subjects from approximately 30 study centers will be randomly assigned (1:1:1:1) to one of four treatment groups. The study consists of a 21-day screening period, a treatment visit and follow-up visits. The protocol was amended and the study was completed with fewer subjects than described in the initial protocol due to impact of COVID-19 on enrollment.
Interventions
- OTHER Placebo
- BIOLOGICAL DAXI for injection 250 U
- BIOLOGICAL DAXI for injection 375 U
- BIOLOGICAL DAXI for injection 500 U
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2018-12-12 |
| Est. Completion | 2020-11-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03821402
The ClinicalTrials.gov registry entry for NCT03821402 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Revance Therapeutics, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03821402 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03821402 about?
NCT03821402 is a clinical study titled "Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity". This is a randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury. The study will be conducted in the U.S.A.,...
What is the current status of trial NCT03821402?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2018-12-12. Estimated completion is 2020-11-23.
What interventions are being tested in trial NCT03821402?
The interventions under investigation include: Placebo (OTHER), DAXI for injection 250 U (BIOLOGICAL), DAXI for injection 375 U (BIOLOGICAL), DAXI for injection 500 U (BIOLOGICAL).
Who is sponsoring clinical trial NCT03821402?
This trial is sponsored by Revance Therapeutics, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.