Clinical trial NCT03977493: IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia
Official title: IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia: a Double-blind Placebo-controlled Randomized Multicenter Study: The "SwissHandSpasm" Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Focal Hand Dystonia
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
Collaborators: name: Clinical Trial Unit Ente Ospedaliero Cantonale
First posted: 2019-06-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Evaluation of the efficacy of IncobotulinumtoxinA on focal hand dystonia (FHD)
timeFrame: 6 weeks
Secondary outcomes:
measure: Evaluation of the efficacy of IncobotulinumtoxinA on FHD
timeFrame: 12 weeks
measure: Evaluation of the effect of IncobotulinumtoxinA on FHD symptoms severity
timeFrame: 6 and 12 weeks
measure: Evaluation of the effect of IncobotulinumtoxinA on functional status
timeFrame: 6 and 12 weeks
measure: Evaluation of the effect of IncobotulinumtoxinA on writer's cramp improvement
timeFrame: 6 and 12 weeks
measure: Evaluation of the effect of IncobotulinumtoxinA on disease improvement
timeFrame: 6 and 12 weeks
measure: Evaluation of the effect of IncobotulinumtoxinA on writing pressure
timeFrame: 6 and 12 weeks
measure: Evaluation of the effect of IncobotulinumtoxinA on writing speed
timeFrame: 6 and 12 weeks
measure: Evaluation of the effect of IncobotulinumtoxinA on muscle strength
timeFrame: 6 and 12 weeks
measure: Evaluation of the responders to IncobotulinumtoxinA treatment
timeFrame: 6 and 12 weeks
measure: Evaluation of the overall satisfaction of the patients following IncobotulinumtoxinA treatment
timeFrame: 6 weeks
measure: Need of re-injection
timeFrame: 6 weeks
measure: Safety outcomes: adverse events
timeFrame: 6 and 12 weeks
measure: Safety outcomes: pain
timeFrame: 6 and 12 weeks
measure: Safety outcomes: weakness
timeFrame: 6 and 12 weeks
measure: Evaluation of the effect of IncobotulinumtoxinA on depressive symptoms
timeFrame: 6 and 12 weeks
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Inselspital - University Hospital Berne
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois (CHUV)
city: Lugano
country: Switzerland
facility: Neurocentro della Svizzera Italiana
city: St.Gallen
country: Switzerland
facility: Neurocenter of St. Gallen
city: Zurich
country: Switzerland
facility: USZ- Univerity Hospital Zurich
Study officials:
References: