IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia (NCT03977493) | Clinical Trial Compass
RecruitingPhase 3
IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia
Switzerland48 participantsStarted 2018-02-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Informed Consent as documented by signature
* Age ≥ 18 years
* Focal hand dystonia (FHD). Diagnosis must be made by a neurologist specialized in movement disorder (at least 2 years specific training, all partners listed have at least 2 years training)
* Both idiopathic and secondary FHD are allowed
* Both drug naive subjects and subjects previously treated with other BoNT-A will be included
* Patients must be willing and able to comply with the study procedures
* Female patients of childbearing potential must agree to use an effective method of contraception during the treatment period
Exclusion Criteria:
* Presence of spasticity, or other central sensorimotor lesion of motor system other than dystonia in the affected limb
* Peripheral nerve lesion (diagnosis either clinical or electrophysiological) in the affected limb, for example with a muscle weakness at baseline
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to BoNT-A toxins including IncobotulinumtoxinA
* Doses and schedules of any ongoing treatment with potential confounding drugs such as muscle relaxants (for example Tolperison, Tizinadid, Baclofen, Mestinon, Dantrolen), benzodiazepine, neuroleptics or antidepressants have to be kept unchanged throughout the study and no changes should be made between the first trial injection and the end of study visit at week 12.
* Previous treatment with other BoNT-A less than 3 months before the inclusion in t…
What they're measuring
1
Evaluation of the efficacy of IncobotulinumtoxinA on focal hand dystonia (FHD)