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Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin

NCT05103202 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2022-06-30

No results posted yet for this 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.

Conditions

  • Cervical Dystonia
  • Blepharospasm
  • Limb Dystonia
  • Hemifacial Spasm
  • Spasticity, Muscle
  • Fragments of Torsion Dystonia

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Richard B Dewey, Jr., MD · UT Southwestern Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-04
Primary Completion
2022-03-07
Completion
2022-06-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05103202 on ClinicalTrials.gov