Health TrialsbyHealthPanel

IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia

ConditionFocal Hand Dystonia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlain Kaelin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Xeomin

    Drug

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

  • Placebo - Concentrate

    Drug

    One injection in each muscle.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Xeomin®Active comparator 1 intervention
Group B: Placebo concentratePlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
6 weeks

Secondary outcomes

1

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.

Time frame
12 weeks
2

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).

Time frame
6 and 12 weeks
3

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).

Time frame
6 and 12 weeks
4

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).

Time frame
6 and 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alain Kaelin

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Sponsor institution

Clinical Trial Unit Ente Ospedaliero Cantonale

Collaborator

Source ClinicalTrials.gov
Apply now