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: Completed Phase 2 study, sponsored by Revance Therapeutics.
NCT03821402 is a Phase 2 study that has completed, run by Revance Therapeutics. The registered enrollment target is 83 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mean change from baseline at Week 6 in muscle tone measured with the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) in one of the following: elbow, wrist, or finger flexors. Score range: 0 (Normal tone, no in tone) to 4 (Affected part{s} rigid in flexion or extension).
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 |
What the finished NCT03821402 record still lists
NCT03821402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03821402 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03821402's enrollment target sits among peer trials
83 828th of 2000 higher than 1,171 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02974647 · 83 participants · Phase 2
Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
- NCT03919292 · 83 participants · Phase 1
Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca
- NCT04626674 · 83 participants · Phase 1
A Gene Transfer Therapy Study to Evaluate the Safety of and Expression From Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
- NCT05277168 · 83 participants · Phase 1
A Trial TO Evaluate THE Safety, Tolerability, Pharmacokinetics, AND Efficacy OF Shr-a1904 IN Subjects With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI