Ipsen Clinical Study Enquiries

CONTACT

Lead Sponsor

Ipsen

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

•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

•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.