IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia
ConditionFocal Hand Dystonia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlain Kaelin
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Xeomin
- Placebo - Concentrate
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Alain Kaelin
Lead sponsor
Ente Ospedaliero Cantonale, Bellinzona
Sponsor institution
Clinical Trial Unit Ente Ospedaliero Cantonale
Collaborator
Source ClinicalTrials.gov