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

NCT05103202 | Completed

• 1 other identifier: STU-2021-0224
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Quality of Life measured by Short Form 36 (SF-36)

  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)

  single measure at 1 day of enrollment

• Safety of injection

  Side effects recorded qualitatively and graded by severity (0 to 4 numerical subjective grade where 4 is most severe) by the injecting physician and attributed by that physician to the most recent injection

  single measure at 1 day of enrollment

Secondary Outcomes (6)

• Blepharospasm disability index survey (BSDI)

  single measure at 1 day of enrollment

• Cervicocranial dystonia questionnaire (CDQ24)

  single measure at 1 day of enrollment

• Arm Dystonia Disability Scale (ADDS)

  single measure at 1 day of enrollment

• Hemifacial Spasm Scale (HFS7)

  single measure at 1 day of enrollment

• Oromandibular dystonia questionnaire (OMDQ-25)

  single measure at 1 day of enrollment

Study Arms (2)

10 weeks or less

Patients receiving botulinum toxin injections at a frequency of 10 weeks or less

12 weeks or more

Patients receiving botulinum toxin injections at a frequency of 12 weeks or more

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be recruited consecutively on presentation for treatment of muscle spasm due to neurological disease with botulinum toxin to the UT Southwestern Movement Disorders clinic by one of the investigators.

You may qualify if:

• Aim 1:
• 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
• Aim 2:
• 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
• If receiving injections at 12-weeks or more, notes must have previously indicated that patient needs an injection interval of 10-weeks or less
• If receiving injections at 12-weeks or more, the reason must be that the insurance carrier covering that patient's medical costs refused to allow a 10-week or less injection frequency

You may not qualify if:

• For both Aims 1 and 2:
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (14)

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• Wissel J. Towards flexible and tailored botulinum neurotoxin dosing regimens for focal dystonia and spasticity - Insights from recent studies. Toxicon. 2018 Jun 1;147:100-106. doi: 10.1016/j.toxicon.2018.01.018. Epub 2018 Jan 31.

  PMID: 29407165 BACKGROUND

• Truong DD, Gollomp SM, Jankovic J, LeWitt PA, Marx M, Hanschmann A, Fernandez HH; Xeomin US Blepharospasm Study Group. Sustained efficacy and safety of repeated incobotulinumtoxinA (Xeomin((R))) injections in blepharospasm. J Neural Transm (Vienna). 2013 Sep;120(9):1345-53. doi: 10.1007/s00702-013-0998-9. Epub 2013 Feb 23.

  PMID: 23435927 BACKGROUND

• Evidente VG, Truong D, Jankovic J, Comella CL, Grafe S, Hanschmann A. IncobotulinumtoxinA (Xeomin(R)) injected for blepharospasm or cervical dystonia according to patient needs is well tolerated. J Neurol Sci. 2014 Nov 15;346(1-2):116-20. doi: 10.1016/j.jns.2014.08.004. Epub 2014 Aug 10.

  PMID: 25186131 BACKGROUND

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  PMID: 8196686 BACKGROUND

• Jankovic J, Vuong KD, Ahsan J. Comparison of efficacy and immunogenicity of original versus current botulinum toxin in cervical dystonia. Neurology. 2003 Apr 8;60(7):1186-8. doi: 10.1212/01.wnl.0000055087.96356.bb.

  PMID: 12682332 BACKGROUND

• Ruta D, Garratt A, Abdalla M, Buckingham K, Russell I. The SF 36 health survey questionnaire. A valid measure of health status.. BMJ. 1993 Aug 14;307(6901):448-9. doi: 10.1136/bmj.307.6901.448-b. No abstract available.

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  PMID: 19053054 BACKGROUND

• Muller J, Wissel J, Kemmler G, Voller B, Bodner T, Schneider A, Wenning GK, Poewe W. Craniocervical dystonia questionnaire (CDQ-24): development and validation of a disease-specific quality of life instrument. J Neurol Neurosurg Psychiatry. 2004 May;75(5):749-53. doi: 10.1136/jnnp.2003.013441.

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• Peterson DA, Berque P, Jabusch HC, Altenmuller E, Frucht SJ. Rating scales for musician's dystonia: the state of the art. Neurology. 2013 Aug 6;81(6):589-98. doi: 10.1212/WNL.0b013e31829e6f72. Epub 2013 Jul 24.

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• Fahn, S., Assessment of the primary dystonias, in Quantification of Neurologic Deficit, M. TL, Editor. 1989, Butterworths: Oxford. p. 241-270.

  BACKGROUND

• Merz RI, Deakin J, Hawthorne MR. Oromandibular dystonia questionnaire (OMDQ-25): a valid and reliable instrument for measuring health-related quality of life. Clin Otolaryngol. 2010 Oct;35(5):390-6. doi: 10.1111/j.1749-4486.2010.02194.x.

  PMID: 21108749 BACKGROUND

• Turner-Stokes L, Ashford S, Jacinto J, Maisonobe P, Balcaitiene J, Fheodoroff K. Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III). BMJ Open. 2016 Jun 17;6(6):e011157. doi: 10.1136/bmjopen-2016-011157.

  PMID: 27315835 BACKGROUND

MeSH Terms

Conditions

Torticollis; Blepharospasm; Dystonia; Hemifacial Spasm; Muscle Spasticity

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eyelid Diseases; Eye Diseases; Nervous System Diseases; Mouth Diseases; Stomatognathic Diseases; Spasm; Neuromuscular Manifestations; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia

Study Officials

• Richard B Dewey, Jr., MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: November 4, 2021
• Primary Completion: March 7, 2022
• Study Completion: June 14, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)