IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia

Focal Hand Dystonia Clinical Trial

Official title:

IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia: a Double-blind Placebo-controlled Randomized Multicenter Study: The "SwissHandSpasm" Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03977493
• Other study ID #: NSI-BTX-001
• Status: Recruiting
• Phase: Phase 3
• Start date: February 21, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Alain Kaelin, Prof.
• Phone: +41 (0)91 811 62 57
• Email: alain.kaelin[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Focal Hand Dystonia

Intervention

Drug:
• Xeomin
One injection of 2.5 to 40 U in each muscle. Injection repeated after 6 weeks if considered necessary
• Placebo - Concentrate
One injection in each muscle.

Locations

Country	Name	City	State
Switzerland	Inselspital - University Hospital Berne	Berne
Switzerland	Centre hospitalier universitaire vaudois (CHUV)	Lausanne
Switzerland	Neurocentro della Svizzera Italiana	Lugano
Switzerland	Neurocenter of St. Gallen	St.Gallen
Switzerland	USZ- Univerity Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Alain Kaelin	Clinical Trial Unit Ente Ospedaliero Cantonale

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Secondary	Evaluation of the efficacy of IncobotulinumtoxinA on 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.	12 weeks
Secondary	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).	6 and 12 weeks
Secondary	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).	6 and 12 weeks
Secondary	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).	6 and 12 weeks
Secondary	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).	6 and 12 weeks
Secondary	Evaluation of the effect of IncobotulinumtoxinA on writing pressure	To measure the change in writing pressure by using a pressure sensitive-tablet. Writing Movement pressure will be measured in Pascal.	6 and 12 weeks
Secondary	Evaluation of the effect of IncobotulinumtoxinA on writing speed	To measure the change in writing speed by using a pressure sensitive-tablet. Writing movement speed will be measured in seconds.	6 and 12 weeks
Secondary	Evaluation of the effect of IncobotulinumtoxinA on muscle strength	To measure the change in muscle strength by using the Medical Research Council Scale for Muscle strength. The patient's effort is graded on a scale of 0 (normal muscle) to 5 (no movement).	6 and 12 weeks
Secondary	Evaluation of the responders to IncobotulinumtoxinA treatment	Number of patients showing an improvement of FHD by = 1 points over baseline	6 and 12 weeks
Secondary	Evaluation of the overall satisfaction of the patients following IncobotulinumtoxinA treatment	Patients will answer the following two questions: a) Considering all advantages and disadvantages of this treatment, is the improvement such that you wish to continue this treatment or not? Yes/No b) Do you think that you would need an injection of IncobotulinumtoxinA today? Yes/No	6 weeks
Secondary	Need of re-injection	The physician will judge about whether an injection with IncobotulinumtoxinA is recommended or not (Yes/No)	6 weeks
Secondary	Safety outcomes: adverse events	Incidence and severity of adverse reactions (mild, moderate, severe).	6 and 12 weeks
Secondary	Safety outcomes: pain	Pain assessed by VAS scale. The VAS for pain is a self-assessment scale drawn by the patients on a 10-cm line, on which 0 indicates no pain and 10 an extreme amount of pain.	6 and 12 weeks
Secondary	Safety outcomes: weakness	Weakness assessed by using the CGI-side effect scale and CGI-weakness scale. CGI-side effect scale ranges from 0 to 3 (no, mild, marked, severe side effects). CGI-weakness assessment scale ranges from 0 to 4 (none, <25%, 26-50%, 51-75%, 76-100% reduction in normal strength).	6 and 12 weeks
Secondary	Evaluation of the effect of IncobotulinumtoxinA on depressive symptoms	To measure the change in depressive symptoms by using the Beck Depression Inventory (BDI). Total BDI score ranges from 0 to 63 with scores > 29 indicating severe depression and > 40 extreme depression.	6 and 12 weeks