Actively Recruiting
IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia
Led by Alain Kaelin · Updated on 2026-03-19
48
Participants Needed
5
Research Sites
514 weeks
Total Duration
On this page
Sponsors
A
Alain Kaelin
Lead Sponsor
C
Clinical Trial Unit Ente Ospedaliero Cantonale
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older
- Diagnosis of focal hand dystonia confirmed by a neurologist specialized in movement disorders
- Includes both idiopathic and secondary focal hand dystonia
- Both patients new to botulinum toxin treatment and those previously treated are eligible
- Ability and willingness to follow study procedures
- Female patients of childbearing potential must agree to use effective contraception during treatment
You will not qualify if you...
- Presence of spasticity or other central sensorimotor lesions in the affected limb besides dystonia
- Peripheral nerve lesion in the affected limb causing muscle weakness
- Known hypersensitivity or allergy to botulinum toxin A including IncobotulinumtoxinA
- Changes in doses or schedules of muscle relaxants, benzodiazepines, neuroleptics, or antidepressants during the study
- Botulinum toxin A treatment within 3 months prior to study inclusion
- Pregnancy or breastfeeding
- Inability to follow study procedures due to language or psychological issues
- Participation in another investigational drug study within 30 days before or during this study
- Previous enrollment in this study
- Enrollment of the investigator or related persons
- Severe depression or other significant psychiatric disorders
- INR greater than 2 on injection day if anticoagulated; injection delayed until safer INR
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Inselspital - University Hospital Berne
Bern, Switzerland, 3010
Not Yet Recruiting
2
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Switzerland, 1001
Not Yet Recruiting
3
Neurocentro della Svizzera Italiana
Lugano, Switzerland, 6900
Actively Recruiting
4
Neurocenter of St. Gallen
Sankt Gallen, Switzerland, 9007
Not Yet Recruiting
5
USZ- Univerity Hospital Zurich
Zurich, Switzerland, 8091
Not Yet Recruiting
Research Team
A
Alain Kaelin, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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