Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT03977493

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia | DecenTrialz