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A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults

RecruitingPhase 2Ages 18 Years - 80 YearsAllIpsen
NCT06937931 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the efficacy and safety of the study drug, Corabotase (also known as IPN10200), and to assess how well it works when compared with placebo in treating Cervical Dystonia (CD) in adults. CD can cause a series of abnormalities and symptoms in the head and neck that can lead to neck pain and stiffness, and headaches. CD is believed to involve deep parts within the brain that control movement, but genetic factors, environmental factors, and abnormalities in the brain may also play a role. The usual treatment for CD includes injecting BoNT into the affected muscles, but the treatment only lasts about 3 months. Corabotase is designed to last for a longer period. The study will consist of two periods: 1. A Screening Period of up to 4 weeks (28 days) to assess whether a participant can take part in the study and requires at least one visit. 2. A Treatm

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. A clinical diagnosis of isolated Cervical Dystonia (CD) (idiopathic) characterized by dystonic symptoms localised to the head, neck, and shoulder areas with at least moderate severity at Screening and Baseline (Day 1) defined as: * (a) Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score ≥20 * (b) TWSTRS-Severity subscale score ≥15 * (c) TWSTRS-Disability subscale score ≥3 * (d) TWSTRS-Pain subscale score ≥ 1 2. Treatment naïve or non-naïve to BoNT therapy for CD Exclusion Criteria: 1. Participants presenting with a swallowing disorder of any origin which might be exacerbated by BoNT treatment, such as: * (a) Grade 3 or 4 on the Dysphagia Severity Scale (severe dysphagia) with swallowing difficulties and requiring a change in diet. 2. Predominant anterocollis. 3. Predominant retrocollis. 4. Traumatic torticollis or tardive torticollis. 5. Marked limitation on passive range of motion that suggests cervical contractures or structural abnormality.
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What it tests

  • Corabotase
  • Placebo
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Where

45 sites
University of Arizona Health Sciences - Neurology
Tucson, United States
Parkinson's & Mvmt Disorders Inst
Fountain Valley, United States
Loma Linda University School of Medicine - Neurology
Loma Linda, United States
Parkinson's Ds & Mvt Disorders Cntr
Boca Raton, United States
USF Health Byrd Alzheimer's Institute
Tampa, United States
Emory Brain Health Center
Atlanta, United States
Rush Medical Center
Chicago, United States
Quest Research Institute
Farmington Hills, United States

…and 37 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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