IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia

NCT03977493 | Recruiting Phase 3

• 1 other identifier: NSI-BTX-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

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.

Conditions

Focal Hand Dystonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Evaluation of the efficacy of IncobotulinumtoxinA on FHD

  12 weeks

• Evaluation of the effect of IncobotulinumtoxinA on FHD symptoms severity

  6 and 12 weeks

• Evaluation of the effect of IncobotulinumtoxinA on functional status

  6 and 12 weeks

• Evaluation of the effect of IncobotulinumtoxinA on writer's cramp improvement

  6 and 12 weeks

• Evaluation of the effect of IncobotulinumtoxinA on disease improvement

  6 and 12 weeks

Study Arms (2)

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).

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).

Drug: Placebo - Concentrate

Interventions

Placebo - Concentrate DRUG

One injection in each muscle.

Placebo concentrate

Xeomin DRUG

One injection of 2.5 to 40 U in each muscle. Injection repeated after 6 weeks if considered necessary

Xeomin®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Alain Kaelin: lead
• Clinical Trial Unit Ente Ospedaliero Cantonale: collaborator

Study Sites (5)

Inselspital - University Hospital Berne

Bern, 3010, Switzerland

NOT YET RECRUITING

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, 1001, Switzerland

NOT YET RECRUITING

Neurocentro della Svizzera Italiana

Lugano, 6900, Switzerland

RECRUITING

Neurocenter of St. Gallen

Sankt Gallen, 9007, Switzerland

NOT YET RECRUITING

USZ- Univerity Hospital Zurich

Zurich, 8091, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Dystonia, Focal, Task-Specific

Interventions

incobotulinumtoxinA

Central Study Contacts

Alain Kaelin, Prof.

CONTACT

+41 (0)91 811 62 57; alain.kaelin@eoc.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Neurocenter of Southern Switzerland

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: June 6, 2019
• Study Start: February 21, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CH (5)