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
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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)
. 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