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| Name | Class |
|---|---|
| Clinical Trial Unit Ente Ospedaliero Cantonale | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xeomin® | Active Comparator | 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). |
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| Placebo concentrate | Placebo Comparator | Intramuscular Placebo injection under guidance (EMG and/or sonographic monitoring), in each muscle (max. 5 forearm- and/or hand muscles). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xeomin | Drug | One injection of 2.5 to 40 U in each muscle. Injection repeated after 6 weeks if considered necessary |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alain Kaelin, Prof. | Contact | +41 (0)91 811 62 57 | alain.kaelin@eoc.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital - University Hospital Berne | Not yet recruiting | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| C566973 | Dystonia, Focal, Task-Specific |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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| Placebo - Concentrate | Drug | One injection in each muscle. |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Evaluation of the responders to IncobotulinumtoxinA treatment | Number of patients showing an improvement of FHD by ≥ 1 points over baseline | 6 and 12 weeks |
| 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 |
| Need of re-injection | The physician will judge about whether an injection with IncobotulinumtoxinA is recommended or not (Yes/No) | 6 weeks |
| Safety outcomes: adverse events | Incidence and severity of adverse reactions (mild, moderate, severe). | 6 and 12 weeks |
| 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 |
| 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 |
| 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 |
| Centre hospitalier universitaire vaudois (CHUV) | Not yet recruiting | Lausanne | 1001 | Switzerland |
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| Neurocentro della Svizzera Italiana | Recruiting | Lugano | 6900 | Switzerland |
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| Neurocenter of St. Gallen | Not yet recruiting | Sankt Gallen | 9007 | Switzerland |
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| USZ- Univerity Hospital Zurich | Not yet recruiting | Zurich | 8091 | Switzerland |
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