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Taking people in ItalyPhase 2

Corabotase compared with placebo for cervical dystonia in adults

Tests corabotase against placebo in adults with cervical dystonia.

Key facts

Who runs it
Ipsen
Where
Bologna, Milan, Pavia, and Reggio Emilia, ItalySee the 5 sitesAlso in 7 other countries, 39 sites
Registry title
A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults
Status
Recruiting
Phase
Phase 2
People taking part
132 people, planned
Started
30 Jun 2025
Expected to end
5 Nov 2027
Type of study
Interventional, 5 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Corabotase
  • Placebo
Record updated
8 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with cervical dystonia, a condition causing involuntary neck muscle tightening, of at least moderate severity. It tests Corabotase (IPN10200) against placebo.

Age
18 Years to 80 Years
Sex
All sexes can join.
Disease stage
Isolated cervical dystonia with no known cause (idiopathic), with symptoms in the head, neck and shoulders. It must be at least moderate: TWSTRS-Total score ≥20, TWSTRS-Severity score ≥15, TWSTRS-Disability score ≥3 and TWSTRS-Pain score ≥ 1.
Earlier treatment
People who have had BoNT (botulinum toxin) treatment for cervical dystonia can join, and so can people who have never had it.

Main reasons for not taking part

  • A swallowing problem that BoNT could make worse, such as severe swallowing difficulty (Grade 3 or 4) needing a diet change.
  • Head mainly pulled forward (predominant anterocollis) or mainly pulled backward (predominant retrocollis).
  • Twisted neck caused by injury, or caused by medicines (tardive torticollis).
  • Strong limits in moving the neck by others, suggesting stiffened tissue or a structural problem.

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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
  • 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 change in diet
  • Predominant anterocollis
  • Predominant retrocollis
  • Traumatic torticollis or tardive torticollis
  • Marked limitation on passive range of motion that suggests cervical contractures or structural abnormality

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in Italy

Also in 7 other countries, 39 sites

  • Azienda Unita Sanitaria Locale Di BolognaBologna, ItalyTaking people
  • IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyTaking people
  • Istituto Auxologico ItalianoMilan, ItalyTaking people
  • Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyTaking people
  • Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 5 groups in the trial

  • Group 1: Treatment Arm ATreatment being tested

    Corabotase - Dose A

    Treatment: Corabotase

  • Group 1: Treatment Arm BTreatment being tested

    Corabotase - Dose B

    Treatment: Corabotase

  • Group 1: Placebo ComparatorPlacebo, for comparison

    Placebo- Group1

    Treatment: Placebo

  • Group 2: Treatment Arm CTreatment being tested

    Corabotase - Dose C

    Treatment: Corabotase

  • Group 2: Placebo ComparatorPlacebo, for comparison

    Placebo- Group 2

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase II, Multicentre, Randomised, Double-blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Safety of IPN10200 as a Treatment for Cervical Dystonia in Adult Participants
Plain-language title
Corabotase compared with placebo for cervical dystonia in adultsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06937931, who can take part
Record updated
8 September 2026