NCT03977493 IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia
| NCT ID | NCT03977493 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Alain Kaelin |
| Condition | Focal Hand Dystonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2018-02-21 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 48 participants in total. It began in 2018-02-21 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03977493 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Focal Hand Dystonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03977493 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 48 participants.
Is NCT03977493 currently recruiting?
Yes, NCT03977493 is actively recruiting participants. Contact the research team at alain.kaelin@eoc.ch for enrollment information.
Where is the NCT03977493 trial being conducted?
This trial is being conducted at Bern, Switzerland, Lausanne, Switzerland, Lugano, Switzerland, Sankt Gallen, Switzerland and 1 additional location.
Who is sponsoring the NCT03977493 clinical trial?
NCT03977493 is sponsored by Alain Kaelin. The trial plans to enroll 48 participants.