NCT03977493

IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia

IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia: a Double-blind Placebo-controlled Randomized Multicenter Study: The "SwissHandSpasm" Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Alain Kaelin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Focal Hand Dystonia

Interventions

Type	Name	Description
DRUG	Xeomin	One injection of 2.5 to 40 U in each muscle. Injection repeated after 6 weeks if considered necessary
DRUG	Placebo - Concentrate	One injection in each muscle.

Timeline

• Start date: 2018-02-21
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2019-06-06
• Last updated: 2026-03-19

Locations

5 sites across 1 country: Switzerland