CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 105 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05103202
NCT05103202N/ACompleted

Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin for the Treatment of Muscle Spasm Associated With Neurological Disorders

University of Texas Southwestern Medical Center·observational·Posted Nov 2, 2021·Updated Jun 30, 2022

In Brief

An observational study for Cervical Dystonia and 5 related conditions. Completed, enrolled 105 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 2, 2021
Enrollment StartNov 4, 2021
Primary CompletionMar 7, 2022
Study CompletionJun 14, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.7 years ago