Using Xeomin to treat focal hand dystonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind, randomized placebo-controlled trial aims to evaluate the effectiveness of intramuscular injections of IncobotulinumtoxinA (Xeomin) in patients with focal hand dystonia. Participants will be randomly assigned to receive either the treatment or a placebo, with assessments conducted by blinded investigators. Efficacy will be measured at 6 weeks and 12 weeks, allowing for a thorough evaluation of the treatment's impact on the condition. Patients dissatisfied with their initial treatment will have the option to receive Xeomin after the first assessment.

Why it matters

Who can join: the full rules

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 this study
* 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 days preceding and during the present study
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Severe depression (\>29 as measured with the Beck Depression Inventory, see Appendix 8) or other relevant psychiatric disorder
* INR \> 2 on the day of injection if the patient is anticoagulated. If INR \> 2, the study injection will be delayed until the return to a safer INR.

Where it's running

• Neurocentro della Svizzera Italiana
  Lugano, Switzerland Recruiting
• Inselspital - University Hospital Berne
  Bern, Switzerland Not yet recruiting
• Centre hospitalier universitaire vaudois (CHUV)
  Lausanne, Switzerland Not yet recruiting
• Neurocenter of St. Gallen
  Sankt Gallen, Switzerland Not yet recruiting
• USZ- Univerity Hospital Zurich
  Zurich, Switzerland Not yet recruiting

Study contacts

• Study coordinator: Alain Kaelin, Prof.
• Email: alain.kaelin@eoc.ch
• Phone: +41 (0)91 811 62 57

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brain network patterns in focal dystonia

  Researchers will use MRI scans and blood tests to try to find brain and genetic differences in adults with focal dystonia, their unaffected relatives, and healthy volunteers.

  Recruiting Massachusetts Eye and Ear Infirmary · Boston, Massachusetts · NCT03042962

• Using GPi brain signals to guide DBS programming for primary dystonia

  This study will test whether recording local field potentials from the globus pallidus interna with the Medtronic Percept device can help guide DBS programming and improve symptoms in adults with primary dystonia.

  Recruiting Newcastle-upon-Tyne Hospitals NHS Trust · Newcastle upon Tyne, Tyne & Wear · NCT07309133

• Unilateral focused ultrasound pallidotomy for medication‑resistant limb dystonia

  This will test whether a non‑invasive focused ultrasound procedure can reduce arm or leg dystonia symptoms in adults who haven't improved with medicines or botulinum toxin.

  Recruiting at 4 sites Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Mestre, (Venice) and 3 other locations · NCT07168850

• Investigating the relationship between genetic mutations and brain changes in dystonia

  This study is trying to see how genetic changes linked to dystonia affect the brain in people with the condition compared to healthy individuals.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT03428009

• Neuromodulation effects on laryngeal dystonia

  This study is testing if a brain stimulation treatment can help people with laryngeal dystonia improve their voice and overall quality of life.

  Recruiting MGH Institute of Health Professions · Boston, Massachusetts · NCT05095740

• Using MRI-guided focused ultrasound to treat hand dystonia

  This study is testing a new ultrasound treatment to see if it can help people with hand dystonia who haven't found relief from other therapies.

  Recruiting University of Maryland, Baltimore · Baltimore, Maryland · NCT06367608

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.