IPN10200 treatment for cervical dystonia in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, placebo-controlled interventional trial enrolls adults with isolated cervical dystonia and required minimum symptom scores on the TWSTRS scale. After a screening period of up to 4 weeks, participants enter a 36-week treatment period in which they receive either IPN10200 (Dose A or Dose B) or placebo on Day 1 and are followed for efficacy and safety outcomes. The protocol allows both patients who are naïve to botulinum toxin (BoNT) and those previously treated with BoNT. Key eligibility limits include exclusion of severe dysphagia, predominant antero- or retrocollis, traumatic or tardive torticollis, and marked cervical contractures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Parkinson's & Mvmt Disorders Inst
  Fountain Valley, California, United States Recruiting
• Parkinson's Ds & Mvt Disorders Cntr
  Boca Raton, Florida, United States Recruiting
• Emory Brain Health Center
  Atlanta, Georgia, United States Recruiting
• Rush Medical Center
  Chicago, Illinois, United States Recruiting
• Quest Research Institute
  Farmington Hills, Michigan, United States Recruiting
• Ichan Sch of Medicine @ Mt. Sinai
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Ipsen Clinical Study Enquiries
• Email: clinical.trials@ipsen.com
• Phone: See e mail

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Targeted Focused Ultrasound for Cervical Dystonia

  This trial tests whether applying theta burst focused ultrasound to brain regions GPi or DN, or a sham, can help people with cervical dystonia.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07690514

• Noninvasive brain stimulation for cervical dystonia using continuous theta-burst in a sham-controlled trial

  This study tests whether delivering continuous theta-burst stimulation to the brain can reduce neck dystonia symptoms compared with sham stimulation.

  Recruiting Fondazione Policlinico Universitario Campus Bio-Medico · Roma, Roma · NCT07681284

• Vibration to improve head posture in cervical dystonia

  This trial will test whether stronger vibration applied to the neck muscles helps correct abnormal head posture in people with cervical dystonia.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT07245615

• Adding zinc to Botox for cervical dystonia

  This will test whether taking daily zinc citrate after a Botox injection helps people with cervical dystonia keep symptom relief longer.

  Recruiting Phase 2 University of Florida · Gainesville, Florida · NCT07140874

• Using Valbenazine with Botulinum Toxin for Cervical Dystonia

  This study is testing if adding a medication called valbenazine to botulinum toxin injections can help people with cervical dystonia feel better and improve their quality of life.

  Recruiting Phase 2 Virginia Commonwealth University · Richmond, Virginia · NCT06771323

• Exercise program for cervical dystonia patients receiving botulinum toxin

  This study tests if a personalized exercise program can help people with cervical dystonia feel better after getting botulinum toxin injections.

  Recruiting Ankara University · Ankara, Altındağ · NCT05502718

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.