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Clinical trial

A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia

ID
Name
Y-47-52120-051
Description
The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.
Trial arms
Trial start
2005-10-10
Estimated PCD
2006-09-01
Trial end
2006-09-01
Status
Completed
Phase
Early phase I
Treatment
Botulinum toxin type A
500 units
Arms:
1
Other names:
AbobotulinumtoxinA (Dysport®)
Placebo
500 units
Arms:
2
Size
116
Primary endpoint
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Baseline and Week 4
Eligibility criteria
Inclusion Criteria: * Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status * TWSTRS severity, disability and total scores meeting the defined criteria at baseline Exclusion Criteria: * Pure anterocollis or pure retrocollis * In apparent remission from cervical dystonia * Previous poor response to the last two botulinum toxin type A or type B treatments * Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 116, 'type': 'ACTUAL'}}
Updated at
2022-09-28

1 organization

2 products

1 indication

Organization
Ipsen
Product
Placebo
Indication
Cervical Dystonia
Product
Botulinum toxin type A