Using Xeomin to treat focal hand dystonia
IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia: a Double-blind Placebo-controlled Randomized Multicenter Study: The "SwissHandSpasm" Study
This study is testing if injections of Xeomin can help people with focal hand dystonia feel better compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 5 sites (Bern and 4 other locations) |
| Trial ID | NCT03977493 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with focal hand dystonia by a qualified neurologist.
Not a fit: Patients with spasticity or other central sensorimotor lesions in the affected limb will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve motor function and quality of life for patients suffering from focal hand dystonia.
How similar studies have performed: Previous studies have shown positive outcomes with botulinum toxin treatments for dystonia, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bern and 4 other locations
- Inselspital - University Hospital Berne — Bern, Switzerland (Not_yet_recruiting)
- Centre hospitalier universitaire vaudois (CHUV) — Lausanne, Switzerland (Not_yet_recruiting)
- Neurocentro della Svizzera Italiana — Lugano, Switzerland (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.