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

Launched by IPSEN · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IPN10200 for adults with Cervical Dystonia (CD), a condition that causes painful and involuntary muscle contractions in the neck, leading to stiffness and discomfort. The trial aims to find out if IPN10200 is effective and safe compared to a placebo, which is a treatment that looks like the real drug but has no active ingredients. Currently, CD is often treated with injections that last about three months, but IPN10200 is designed to provide relief for a longer period.

To participate in this trial, individuals must be diagnosed with isolated Cervical Dystonia and show moderate to severe symptoms. This means they will need to have a certain level of pain and movement issues. Participants will go through a screening process to ensure they qualify and will then take part in a 36-week treatment period, where they may receive either IPN10200 or a placebo. Over the course of the study, participants will have regular visits to the clinic for check-ups, blood tests, and to fill out questionnaires about their experience. The entire study will last up to 40 weeks, which is about 9 months.

Gender

ALL

Eligibility 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.