IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia

Phase 3RecruitingNCT03977493

Alain Kaelin48 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Focal Hand Dystonia

Interventions

XeominDRUG

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

Placebo - ConcentrateDRUG

One injection in each muscle.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

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

Outcomes

Primary Outcomes

Evaluation of the efficacy of IncobotulinumtoxinA on focal hand dystonia (FHD)

To evaluate patient's subjective impairment due to FHD on VAS for handwriting. The VAS for handwriting is a self-assessment scale drawn by the patients on a 10-cm line, on which 0 indicates the worst possible situation and 10 the best possible situation.

Time frame: 6 weeks

Secondary Outcomes

Evaluation of the efficacy of IncobotulinumtoxinA on FHD

Time frame: 12 weeks

Evaluation of the effect of IncobotulinumtoxinA on FHD symptoms severity

To measure change in symptoms severity by using the Symptom Severity Scale (SSS). Total SSS score ranges from 10 (best possible) to 43 (worst possible).

Time frame: 6 and 12 weeks

Evaluation of the effect of IncobotulinumtoxinA on functional status

To measure change in functional status by using the Functional Status Scale (FSS). Total FSS score ranges from 0 (best possible) to 40 (worst possible).

Time frame: 6 and 12 weeks

Evaluation of the effect of IncobotulinumtoxinA on writer's cramp improvement

To measure the change in writer's cramp measured by the Writer's Cramp Rating Scale (WCRS) - only part A. Total WCRS score ranges from 0 (no improvement) to 28 (marked improvement).

Time frame: 6 and 12 weeks

Evaluation of the effect of IncobotulinumtoxinA on disease improvement

To measure the change in the physician's clinical evaluation of the disease by using the CGI-improvement scale. The CGI-improvement scale ranges from 0 to 4 (none, minimal, mild, moderate, excellent).

Central Contacts

Alain Kaelin, Prof.

CONTACT

+41 (0)91 811 62 57 alain.kaelin@eoc.ch

Data from ClinicalTrials.gov

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