Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum T… (NCT05103202) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
United States105 participantsStarted 2021-11-04
Plain-language 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.
Who can participate
SexALL
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Inclusion criteria
✓. Patient provides responses to an internet based survey which includes consent to participate
✓. Patient has been diagnosed with one or more of the conditions for which a HRQoL scale exists and will be employed in this study
✓. Patient has received at least 2 prior injections with botulinum toxin for that condition by one of the study investigators
✓. Both of the two most recent intervals between injections are either a) 10-weeks or less or b) 12-weeks or more
✓. Patient provides responses to an internet based survey which includes consent to participate
✓. Patient has been diagnosed with one or more of the conditions for which a HRQoL scale exists and will be employed in this study
✓. Patient has received at least 2 prior injections with botulinum toxin for that condition by one of the study investigators
✓. Both of the two most recent intervals between injections are either a) 10-weeks or less or b) 12-weeks or more
Exclusion criteria
✕. Patient is unwilling to consent to study procedures (refuses to fill out surveys)
What they're measuring
1
Quality of Life measured by Short Form 36 (SF-36)
Timeframe: single measure at 1 day of enrollment
2
Safety of injection
Timeframe: single measure at 1 day of enrollment
Trial details
NCT IDNCT05103202
SponsorUniversity of Texas Southwestern Medical Center
. Patient has variable injection frequencies such that the two most recent injections do not both meet criteria of being 10-weeks or less in frequency or 12-weeks or more in frequency
✕. Patient has a diagnosis of and is being treated for a condition for which a HRQoL scale does not exist
✕. Patient has insufficient chart documentation to characterize demographics, diagnosis, toxin selected, dose used, and injection frequency employed