Condition or disease | Intervention/treatment | Phase |
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Focal Hand Dystonia | Drug: Xeomin Drug: Placebo - Concentrate | Phase 3 |
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 (Clinical Trial) |
Estimated Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia: a Double-blind Placebo-controlled Randomized Multicenter Study: The "SwissHandSpasm" Study |
Actual Study Start Date : | February 21, 2018 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
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Active Comparator: 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).
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Drug: Xeomin
One injection of 2.5 to 40 U in each muscle. Injection repeated after 6 weeks if considered necessary
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Placebo Comparator: Placebo concentrate
Intramuscular Placebo injection under guidance (EMG and/or sonographic monitoring), in each muscle (max. 5 forearm- and/or hand muscles).
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Drug: Placebo - Concentrate
One injection in each muscle.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alain Kaelin, Prof. | +41 (0)91 811 62 57 | alain.kaelin@eoc.ch |
Switzerland | |
Inselspital - University Hospital Berne | Not yet recruiting |
Berne, Switzerland, 3010 | |
Contact: Niklaus Meier, MD +41 (0)31 632 70 00 niklaus.meier@insel.ch | |
Centre hospitalier universitaire vaudois (CHUV) | Not yet recruiting |
Lausanne, Switzerland, 1001 | |
Contact: David Benninger, MD +41 (0)21 314 12 20 david.benninger@chuv.ch | |
Neurocentro della Svizzera Italiana | Recruiting |
Lugano, Switzerland, 6900 | |
Contact: Alain Kaelin, Prof +41 (0)91 811 62 57 alain.kaelin@eoc.ch | |
Neurocenter of St. Gallen | Not yet recruiting |
St.Gallen, Switzerland, 9007 | |
Contact: Markus Weber, MD +41 (0)71 494 35 81 markus.weber@kssg.ch | |
USZ- Univerity Hospital Zurich | Not yet recruiting |
Zurich, Switzerland, 8091 | |
Contact: Hans-Heinr. Jung, Prof. 41 (0)44 255 55 45 hans.jung@usz.ch |
Tracking Information | |||||
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First Submitted Date ICMJE | April 19, 2019 | ||||
First Posted Date ICMJE | June 6, 2019 | ||||
Last Update Posted Date | April 30, 2020 | ||||
Actual Study Start Date ICMJE | February 21, 2018 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Evaluation of the efficacy of IncobotulinumtoxinA on focal hand dystonia (FHD) [ Time Frame: 6 weeks ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia | ||||
Official Title ICMJE | IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia: a Double-blind Placebo-controlled Randomized Multicenter Study: The "SwissHandSpasm" Study | ||||
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). |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Focal Hand Dystonia | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
48 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Switzerland | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03977493 | ||||
Other Study ID Numbers ICMJE | NSI-BTX-001 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Alain Kaelin, Ente Ospedaliero Cantonale, Bellinzona | ||||
Study Sponsor ICMJE | Alain Kaelin | ||||
Collaborators ICMJE | Clinical Trial Unit Ente Ospedaliero Cantonale | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Ente Ospedaliero Cantonale, Bellinzona | ||||
Verification Date | April 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |