Home › Trials › NCT06937931

IPN10200 treatment for cervical dystonia in adults

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

Phase 2 Interventional Ipsen · NCT06937931

This trial will test whether a single injection of IPN10200 (one of two doses) reduces neck posture problems, pain, and disability better than placebo in adults with cervical dystonia.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment132 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorIpsen Industry-sponsored
Locations44 sites (Tucson, Arizona and 43 other locations)
Trial IDNCT06937931 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with isolated cervical dystonia who meet TWSTRS thresholds (Total ≥20; Severity ≥15; Disability ≥3; Pain ≥1) who do not have severe dysphagia or predominant antero/retrocollis are the intended participants, and both BoNT-naïve and previously treated patients may be eligible.

Not a fit: Patients with severe dysphagia, predominant anterocollis or retrocollis, traumatic or tardive torticollis, marked cervical contractures, or other exclusionary conditions are unlikely to be eligible or to benefit from this investigational treatment.

Why it matters

Potential benefit: If successful, IPN10200 could provide longer-lasting relief of neck posture, pain, and disability than current botulinum toxin injections, reducing how often patients need injections.

How similar studies have performed: Botulinum toxin injections are an established short-term treatment for cervical dystonia but typically last about three months, and long-acting formulations like IPN10200 are relatively novel with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Tucson, Arizona and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cervical Dystonia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.