Back to resultsIncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia
Primary Purpose
Focal Hand Dystonia
Status
Recruiting
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Xeomin
Placebo - Concentrate
Sponsored by
About this trial
This is an interventional treatment trial for Focal Hand Dystonia
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.
Sites / Locations
- Inselspital - University Hospital Berne
- Centre hospitalier universitaire vaudois (CHUV)
- Neurocentro della Svizzera ItalianaRecruiting
- Neurocenter of St. Gallen
- USZ- Univerity Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Xeomin®
Placebo concentrate
Arm Description
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).
Intramuscular Placebo injection under guidance (EMG and/or sonographic monitoring), in each muscle (max. 5 forearm- and/or hand muscles).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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).
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).
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).
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.
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.
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).
Evaluation of the responders to IncobotulinumtoxinA treatment
Number of patients showing an improvement of FHD by ≥ 1 points over baseline
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
Need of re-injection
The physician will judge about whether an injection with IncobotulinumtoxinA is recommended or not (Yes/No)
Safety outcomes: adverse events
Incidence and severity of adverse reactions (mild, moderate, severe).
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.
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).
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.
Full Information
NCT ID
NCT03977493
First Posted
April 19, 2019
Last Updated
March 29, 2023
Sponsor
Alain Kaelin
Collaborators
Clinical Trial Unit Ente Ospedaliero Cantonale
1. Study Identification
Unique Protocol Identification Number
NCT03977493
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alain Kaelin
Collaborators
Clinical Trial Unit Ente Ospedaliero Cantonale
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Hand Dystonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Xeomin®
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Placebo concentrate
Arm Type
Placebo Comparator
Arm Description
Intramuscular Placebo injection under guidance (EMG and/or sonographic monitoring), in each muscle (max. 5 forearm- and/or hand muscles).
Intervention Type
Drug
Intervention Name(s)
Xeomin
Intervention Description
One injection of 2.5 to 40 U in each muscle. Injection repeated after 6 weeks if considered necessary
Intervention Type
Drug
Intervention Name(s)
Placebo - Concentrate
Intervention Description
One injection in each muscle.
Primary Outcome Measure Information:
Title
Evaluation of the efficacy of IncobotulinumtoxinA on focal hand dystonia (FHD)
Description
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 Outcome Measure Information:
Title
Evaluation of the efficacy of IncobotulinumtoxinA on FHD
Description
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
12 weeks
Title
Evaluation of the effect of IncobotulinumtoxinA on FHD symptoms severity
Description
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
Title
Evaluation of the effect of IncobotulinumtoxinA on functional status
Description
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
Title
Evaluation of the effect of IncobotulinumtoxinA on writer's cramp improvement
Description
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
Title
Evaluation of the effect of IncobotulinumtoxinA on disease improvement
Description
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).
Time Frame
6 and 12 weeks
Title
Evaluation of the effect of IncobotulinumtoxinA on writing pressure
Description
To measure the change in writing pressure by using a pressure sensitive-tablet. Writing Movement pressure will be measured in Pascal.
Time Frame
6 and 12 weeks
Title
Evaluation of the effect of IncobotulinumtoxinA on writing speed
Description
To measure the change in writing speed by using a pressure sensitive-tablet. Writing movement speed will be measured in seconds.
Time Frame
6 and 12 weeks
Title
Evaluation of the effect of IncobotulinumtoxinA on muscle strength
Description
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).
Time Frame
6 and 12 weeks
Title
Evaluation of the responders to IncobotulinumtoxinA treatment
Description
Number of patients showing an improvement of FHD by ≥ 1 points over baseline
Time Frame
6 and 12 weeks
Title
Evaluation of the overall satisfaction of the patients following IncobotulinumtoxinA treatment
Description
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
Time Frame
6 weeks
Title
Need of re-injection
Description
The physician will judge about whether an injection with IncobotulinumtoxinA is recommended or not (Yes/No)
Time Frame
6 weeks
Title
Safety outcomes: adverse events
Description
Incidence and severity of adverse reactions (mild, moderate, severe).
Time Frame
6 and 12 weeks
Title
Safety outcomes: pain
Description
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.
Time Frame
6 and 12 weeks
Title
Safety outcomes: weakness
Description
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).
Time Frame
6 and 12 weeks
Title
Evaluation of the effect of IncobotulinumtoxinA on depressive symptoms
Description
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.
Time Frame
6 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain Kaelin, Prof.
Phone
+41 (0)91 811 62 57
Email
alain.kaelin@eoc.ch
Facility Information:
Facility Name
Inselspital - University Hospital Berne
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niklaus Meier, MD
Phone
+41 (0)31 632 70 00
Email
niklaus.meier@insel.ch
Facility Name
Centre hospitalier universitaire vaudois (CHUV)
City
Lausanne
ZIP/Postal Code
1001
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Benninger, MD
Phone
+41 (0)21 314 12 20
Email
david.benninger@chuv.ch
Facility Name
Neurocentro della Svizzera Italiana
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Kaelin, Prof
Phone
+41 (0)91 811 62 57
Email
alain.kaelin@eoc.ch
Facility Name
Neurocenter of St. Gallen
City
St.Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Weber, MD
Phone
+41 (0)71 494 35 81
Email
markus.weber@kssg.ch
Facility Name
USZ- Univerity Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans-Heinr. Jung, Prof.
Phone
41 (0)44 255 55 45
Email
hans.jung@usz.ch
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia
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