At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- Mix of remote tasks and in-person visits
- Drug or intervention
- Corabotase (biological), Placebo (other)
- How long the study runs
- Study runs about 29 months (dates as stated)
- About the drug or intervention
- Corabotase — biological: Study intervention will be administered in a single treatment cycle after randomisation (Day 1). · Placebo — other: Excipients without active substance will be administered in a single treatment cycle after randomisation (Day 1).
- Patient visit burden
- "There will be 10 visits to the clinic in person and one remote visits (phone call) (12 visits to the clinic for participants who receive Dose C)." (as stated by sponsor)
- Type of study
- Testing a treatment
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 132
- Started
- 2025-06-30
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for cervical dystonia
- • Phase2 - 132 participants
- • 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
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with cervical dystonia
Where?
- • Exeter - Royal Devon And Exeter Hospital - Neurology
- • Fazakerley - The Walton Centre
- • London - University College London Hospitals NHS Foundation Trust - National Hospital for Neurology and Neurosurgery
- • Luton - Luton And Dunstable Hospital - Neurology
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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 Treatment Period of 36 weeks. On Day 1 of the treatment period, participants will receive either Corabotase Dose A or Dose B (additional participants may receive Corabotase Dose C) of the study drug, or placebo distributed into different muscles in the head, neck and shoulders. Participants may continue some other medications, but details need to be recorded. There will be 10 visits to the clinic in person and one remote visits (phone call) (12 visits to the clinic for participants who receive Dose C). Participants will undergo blood samplings, urine collections, physical/neurological examinations, and clinical evaluations. Participants will also need to complete questionnaires throughout the study. The total study duration for a participant will be up to 40 weeks (approximately 9 months).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓(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
- ✓Treatment naïve or non-naïve to BoNT therapy for CD
Who cannot take part
- ✗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...
- ✗Predominant anterocollis.
- ✗Predominant retrocollis.
- ✗Traumatic torticollis or tardive torticollis.
See the full criteria
Where Is This Study? (4 UK sites)
Royal Devon And Exeter Hospital - Neurology
Exeter, United Kingdom
The Walton Centre
Fazakerley, United Kingdom
University College London Hospitals NHS Foundation Trust - National Hospital for Neurology and Neurosurgery
London, United Kingdom
Luton And Dunstable Hospital - Neurology
Luton, United Kingdom
How to Get in Touch
Ipsen Clinical Study Enquiries
Sponsor contactCONTACT