IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia

Sponsor
Alain Kaelin
Study ID
NCT03977493
Phase
PHASE3
Status
Recruiting
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Conditions

  • Focal Hand Dystonia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 21, 2018
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Xeomin®
    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).
  • Placebo Comparator: Placebo concentrate
    Intramuscular Placebo injection under guidance (EMG and/or sonographic monitoring), in each muscle (max. 5 forearm- and/or hand muscles).

Primary Outcome Measure

Evaluation of the efficacy of IncobotulinumtoxinA on focal hand dystonia (FHD) [ Time Frame: 6 weeks ]

Central Contacts