IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia

NCT ID: NCT03977493

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-21
• Study Completion Date: 2025-12-31

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.

Detailed Description

After a baseline evaluation, each patient will receive a first injection of IncobotulinumtoxinA or placebo (50:50 randomization) in a double blinding setting. Assessment of the Focal hand dystonia (FHD) will be done at each site by an investigator blinded to the treatment.

A first evaluation of the efficacy will be performed after 6 weeks. After 6 weeks, patients unsatisfied with treatment and wishing to continue the treatment will receive an injection of IncobotulinumtoxinA regardless of the treatment arm they were initially assigned to at baseline. These patients will subsequently be excluded from the study.

A second assessment will be performed after 12 weeks (only for patients not receiving a second injection of IncobotulinumtoxinA at week 6).

Conditions

Focal Hand Dystonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Xeomin®

Intramuscular IncobotulinumtoxinA (Xeomin®) injection under guidance (EMG and/or sonographic monitoring), 2.5 to 40 U in each muscle (max. 5 forearm- and/or hand muscles).

Group Type: ACTIVE_COMPARATOR

Xeomin

Intervention Type: DRUG

One injection of 2.5 to 40 U in each muscle. Injection repeated after 6 weeks if considered necessary

Placebo concentrate

Intramuscular Placebo injection under guidance (EMG and/or sonographic monitoring), in each muscle (max. 5 forearm- and/or hand muscles).

Group Type: PLACEBO_COMPARATOR

Placebo - Concentrate

Intervention Type: DRUG

One injection in each muscle.

Interventions

Xeomin

One injection of 2.5 to 40 U in each muscle. Injection repeated after 6 weeks if considered necessary

Intervention Type: DRUG

Placebo - Concentrate

One injection in each muscle.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Trial Unit Ente Ospedaliero Cantonale

OTHER

Sponsor Role: collaborator

Alain Kaelin

OTHER

Sponsor Role: lead

Responsible Party

Alain Kaelin

Director of the Neurocenter of Southern Switzerland

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Inselspital - University Hospital Berne

Bern, , Switzerland

Site Status: NOT_YET_RECRUITING

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, , Switzerland

Site Status: NOT_YET_RECRUITING

Neurocentro della Svizzera Italiana

Lugano, , Switzerland

Site Status: RECRUITING

Neurocenter of St. Gallen

Sankt Gallen, , Switzerland

Site Status: NOT_YET_RECRUITING

USZ- Univerity Hospital Zurich

Zurich, , Switzerland

Site Status: NOT_YET_RECRUITING

Countries

Switzerland

Central Contacts

Alain Kaelin, Prof.

Role: CONTACT

alain.kaelin@eoc.ch

+41 (0)91 811 62 57

Facility Contacts

Niklaus Meier, MD

Role: primary

niklaus.meier@insel.ch

+41 (0)31 632 70 00

David Benninger, MD

Role: primary

david.benninger@chuv.ch

+41 (0)21 314 12 20

Alain Kaelin, Prof

Role: primary

alain.kaelin@eoc.ch

+41 (0)91 811 62 57

Markus Weber, MD

Role: primary

markus.weber@kssg.ch

+41 (0)71 494 35 81

Hans-Heinr. Jung, Prof.

Role: primary

hans.jung@usz.ch

41 (0)44 255 55 45

Other Identifiers

NSI-BTX-001

Identifier Type: -

Identifier Source: org_study_id