IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia

Last updated: September 2, 2024
Sponsor: Alain Kaelin
Overall Status: Active - Recruiting

Phase

3

Condition

Dyskinesias

Dystonia

Treatment

Xeomin

Placebo - Concentrate

Clinical Study ID

NCT03977493
NSI-BTX-001
  • Ages > 18
  • All Genders

Study Summary

This study is a multicenter, double-blind, randomized placebo controlled, parallel group, superiority trial in order to test the superiority of intramuscular injections of IncobotulinumtoxinA against placebo using a 1:1 allocation ratio.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed Consent as documented by signature

  • Age ≥ 18 years

  • Focal hand dystonia (FHD). Diagnosis must be made by a neurologist specialized inmovement disorder (at least 2 years specific training, all partners listed have atleast 2 years training)

  • Both idiopathic and secondary FHD are allowed

  • Both drug naive subjects and subjects previously treated with other BoNT-A will beincluded

  • Patients must be willing and able to comply with the study procedures

  • Female patients of childbearing potential must agree to use an effective method ofcontraception during the treatment period

Exclusion

Exclusion Criteria:

  • Presence of spasticity, or other central sensorimotor lesion of motor system otherthan dystonia in the affected limb

  • Peripheral nerve lesion (diagnosis either clinical or electrophysiological) in theaffected limb, for example with a muscle weakness at baseline

  • Contraindications to the class of drugs under study, e.g. known hypersensitivity orallergy to BoNT-A toxins including IncobotulinumtoxinA

  • Doses and schedules of any ongoing treatment with potential confounding drugs suchas muscle relaxants (for example Tolperison, Tizinadid, Baclofen, Mestinon,Dantrolen), benzodiazepine, neuroleptics or antidepressants have to be keptunchanged throughout the study and no changes should be made between the first trialinjection and the end of study visit at week 12.

  • Previous treatment with other BoNT-A less than 3 months before the inclusion in thisstudy

  • Women who are pregnant or breast feeding,

  • Inability to follow the procedures of the study, e.g. due to language problems,psychological disorders, dementia, etc. of the participant

  • Participation in another study with investigational drug within the 30 dayspreceding and during the present study

  • Previous enrolment into the current study

  • Enrolment of the investigator, his/her family members, employees and other dependentpersons

  • Severe depression (>29 as measured with the Beck Depression Inventory, see Appendix

  1. or other relevant psychiatric disorder
  • INR > 2 on the day of injection if the patient is anticoagulated. If INR > 2, thestudy injection will be delayed until the return to a safer INR.

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Xeomin
Phase: 3
Study Start date:
February 21, 2018
Estimated Completion Date:
December 31, 2024

Study Description

After a baseline evaluation, each patient will receive a first injection of IncobotulinumtoxinA or placebo (50:50 randomization) in a double blinding setting. Assessment of the Focal hand dystonia (FHD) will be done at each site by an investigator blinded to the treatment.

A first evaluation of the efficacy will be performed after 6 weeks. After 6 weeks, patients unsatisfied with treatment and wishing to continue the treatment will receive an injection of IncobotulinumtoxinA regardless of the treatment arm they were initially assigned to at baseline. These patients will subsequently be excluded from the study.

A second assessment will be performed after 12 weeks (only for patients not receiving a second injection of IncobotulinumtoxinA at week 6).

Connect with a study center

  • Inselspital - University Hospital Berne

    Berne, 3010
    Switzerland

    Site Not Available

  • Centre hospitalier universitaire vaudois (CHUV)

    Lausanne, 1001
    Switzerland

    Site Not Available

  • Neurocentro della Svizzera Italiana

    Lugano, 6900
    Switzerland

    Site Not Available

  • Neurocenter of St. Gallen

    St.Gallen, 9007
    Switzerland

    Site Not Available

  • USZ- Univerity Hospital Zurich

    Zurich, 8091
    Switzerland

    Site Not Available

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