IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia

Focal Hand Dystonia Clinical Trial

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

Status Recruiting

Clinical 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Focal Hand Dystonia

• NCT number: NCT03977493
• Study type: Interventional
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Alain Kaelin, Prof.
• Phone: +41 (0)91 811 62 57
• Email: alain.kaelin@eoc.ch
• Status: Recruiting
• Phase: Phase 3
• Start date: February 21, 2018
• Completion date: December 31, 2024