Focal Hand DystoniaPhase 3NCT03977493
IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia
A Phase 3 study testing Xeomin in people with Focal Hand Dystonia, run by Alain Kaelin at 5 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Hand Dystonia
- What is being tested?
- Xeomin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 21 Feb 2018to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Switzerland5 sites, 5 recruiting
- Not yet recruiting
Inselspital - University Hospital Berne
Bern, 3010
Niklaus Meier, MD, +41 (0)31 632 70 00, niklaus.meier@insel.ch
- Not yet recruiting
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, 1001
David Benninger, MD, +41 (0)21 314 12 20, david.benninger@chuv.ch
- Recruiting
Neurocentro della Svizzera Italiana
Lugano, 6900
Alain Kaelin, Prof, +41 (0)91 811 62 57, alain.kaelin@eoc.ch
- Not yet recruiting
Neurocenter of St. Gallen
Sankt Gallen, 9007
Markus Weber, MD, +41 (0)71 494 35 81, markus.weber@kssg.ch
- Not yet recruiting
USZ- Univerity Hospital Zurich
Zurich, 8091
Hans-Heinr. Jung, Prof., 41 (0)44 255 55 45, hans.jung@usz.ch
About this study
Official title: IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia: a Double-blind Placebo-controlled Randomized Multicenter Study: The "SwissHandSpasm" Study
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.
Read the 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).
- Conditions
- Focal Hand Dystonia
- Being tested
- Xeomin, Placebo - Concentrate
- Medical subject headings
- Dystonia, Focal, Task-Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XeominDrug
One injection of 2.5 to 40 U in each muscle. Injection repeated after 6 weeks if considered necessary
Placebo - ConcentrateDrug
One injection in each muscle.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Xeomin |
| Placebo concentrate | Placebo comparator | Intramuscular Placebo injection under guidance (EMG and/or sonographic monitoring), in each muscle (max. 5 forearm- and/or hand muscles). Receives: Drug: Placebo - Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (15)
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.
Measured: 12 weeks
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6 and 12 weeks
Evaluation of the responders to IncobotulinumtoxinA treatment
Number of patients showing an improvement of FHD by ≥ 1 points over baseline
Measured: 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
Measured: 6 weeks
Need of re-injection
The physician will judge about whether an injection with IncobotulinumtoxinA is recommended or not (Yes/No)
Measured: 6 weeks
Safety outcomes: adverse events
Incidence and severity of adverse reactions (mild, moderate, severe).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start21 Feb 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Hand DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alain Kaelin
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Responsible party
- Sponsor-investigator, Alain Kaelin, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977493
- Sponsor's protocol ID
- NSI-BTX-001
- Status last verified
- Mar 2026
- First submitted
- 19 Apr 2019
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia: a Double-blind Placebo-controlled Randomized Multicenter Study: The "SwissHandSpasm" Study
- ClinicalTrials.gov ID
- NCT03977493
- Acronym / sponsor ID
- NSI-BTX-001
- Conditions
- Focal Hand Dystonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Alain KaelinUniversity, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xeomin® | Active comparator | Drug: XeominIntramuscular 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). |
| Placebo concentrate | Placebo comparator | Drug: Placebo - ConcentrateIntramuscular Placebo injection under guidance (EMG and/or sonographic monitoring), in each muscle (max. 5 forearm- and/or hand muscles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XeominOne injection of 2.5 to 40 U in each muscle. Injection repeated after 6 weeks if considered necessary | Drug | Xeomin® |
| Placebo - ConcentrateOne injection in each muscle. | Drug | Placebo concentrate |
Primary outcome
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.
15 secondary outcomes
Evaluation of the efficacy of IncobotulinumtoxinA on FHD
Time frame: 12 weeks
Evaluation of the effect of IncobotulinumtoxinA on FHD symptoms severity
Time frame: 6 and 12 weeks
Evaluation of the effect of IncobotulinumtoxinA on functional status
Time frame: 6 and 12 weeks
Evaluation of the effect of IncobotulinumtoxinA on writer's cramp improvement
Time frame: 6 and 12 weeks
Evaluation of the effect of IncobotulinumtoxinA on disease improvement
Time frame: 6 and 12 weeks
Evaluation of the effect of IncobotulinumtoxinA on writing pressure
Time frame: 6 and 12 weeks
Evaluation of the effect of IncobotulinumtoxinA on writing speed
Time frame: 6 and 12 weeks
Evaluation of the effect of IncobotulinumtoxinA on muscle strength
Time frame: 6 and 12 weeks
Evaluation of the responders to IncobotulinumtoxinA treatment
Time frame: 6 and 12 weeks
Evaluation of the overall satisfaction of the patients following IncobotulinumtoxinA treatment
Time frame: 6 weeks
Need of re-injection
Time frame: 6 weeks
Safety outcomes: adverse events
Time frame: 6 and 12 weeks
Safety outcomes: pain
Time frame: 6 and 12 weeks
Safety outcomes: weakness
Time frame: 6 and 12 weeks
Evaluation of the effect of IncobotulinumtoxinA on depressive symptoms
Time frame: 6 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xeomin in people with Focal Hand Dystonia, run by Alain Kaelin at 5 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain Kaelin, Prof. (+41 (0)91 811 62 57, alain.kaelin@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of IncobotulinumtoxinA on focal hand dystonia (FHD) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.