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IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2027v7
  2. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v6
  3. Re-verified, no change to tracked fieldsv5
  4. Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024v4
  5. Primary completion date: Dec 31, 2020 to Dec 31, 2023
    • Study completion date: Dec 31, 2021 to Dec 31, 2023
    v3
  6. Study sites: 4 to 5
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints revised (15)
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03977493
Lead Sponsor Alain Kaelin
Collaborators: Clinical Trial Unit Ente Ospedaliero Cantonale
Conditions
(from sponsor)		 Focal Hand Dystonia
Related terms Dystonia, Focal, Task-Specific
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov