Status:
RECRUITING
A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults
Lead Sponsor:
Ipsen
Conditions:
Cervical Dystonia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of the study drug, IPN10200, and to assess how well it works when compared with placebo in treating Cervical Dystonia (CD) in adults. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 5 2027
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06937931
Start Date
June 30 2025
End Date
November 5 2027
Last Update
December 30 2025
Active Locations (44)
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1
University of Arizona Health Sciences - Neurology
Tucson, Arizona, United States, 85724
2
Parkinson's & Mvmt Disorders Inst
Fountain Valley, California, United States, 92708
3
Parkinson's Ds & Mvt Disorders Cntr
Boca Raton, Florida, United States, 33486
4
USF Health Byrd Alzheimer's Institute
Tampa, Florida, United States, 33613