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NCT05103202 · ClinicalTrials.gov registry record
Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
A clinical trial of Cervical Dystonia and Spasticity, Muscle, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- 105
- Enrollment target
- 1
- Study location
NCT05103202: Completed study of Cervical Dystonia and Spasticity, Muscle, sponsored by University of Texas Southwestern Medical Center.
NCT05103202 is a study of Cervical Dystonia and Spasticity, Muscle that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 105 participants, above the 80-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (31% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05103202, a study of Cervical Dystonia and Spasticity, Muscle, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- 105 participants
- Enrollment target
- 1
- Study location
Study Summary
Our hypothesis is that botulinum toxin injections (with onabotulinum toxin, incobotulinum toxin, and abobotulinum toxin) given at 10-week or shorter intervals for the indication of treatment of muscle spasms associated with neurological disorders are associated with equal safety and effectiveness as those given at 12-week or longer intervals. We also hypothesize that for those patients who would prefer a shorter inter-injection interval, but for whom their insurance carrier has prevented this, have worse health-related quality of life compared to patients who receive injections at a 10-week or shorter interval. We aim to investigate this hypothesis by collecting demographic and injection data and patient survey responses.
Primary Outcome
SF-36 HRQoL score as collected by a patient-completed survey (measured from 0 to 100 with a scoring system where 100 is best quality of life)
Conditions Studied
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2021-11-04 |
| Est. Completion | 2022-06-14 |
What the finished NCT05103202 record still lists
NCT05103202 is an observational study that tracks outcomes without assigning an intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 80-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (31% higher).
The record links to 6 conditions, with Cervical Dystonia appearing as the primary indexed condition, and to 0 interventions.
NCT05103202 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05103202 about?
NCT05103202 is a clinical study titled "Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin". Our hypothesis is that botulinum toxin injections (with onabotulinum toxin, incobotulinum toxin, and abobotulinum toxin) given at 10-week or shorter intervals for the indication of treatment of muscle spasms associated with neurological disorders are associated with equal safety and effectiveness as...
What is the current status of trial NCT05103202?
This trial is currently completed. The enrollment target is 105 participants. The study started on 2021-11-04. Estimated completion is 2022-06-14.
What conditions does trial NCT05103202 study?
This clinical trial studies the following conditions: Cervical Dystonia, Spasticity, Muscle, Blepharospasm, Hemifacial Spasm, Limb Dystonia.
Who is sponsoring clinical trial NCT05103202?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05103202 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05103202's enrollment target sits among peer trials
105 5th of 15 higher than 11 of 15 other Cervical Dystonia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Dystonia 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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