Clinical trial

A Phase III, Prospective, Multicenter, Open-label Extension Study to Assess the Longer Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Cervical Dystonia

NCT00288509

Name

Y-47-52120-731

Description

The aim of this study is to assess longer term safety and effectiveness of Dysport®.

Trial arms

Trial start

2006-02-01

Estimated PCD

2008-01-01

Trial end

2008-01-01

Status

Completed

Phase

Early phase I

Treatment

Botulinum toxin type A

In this long-term extension study, a dose of 500 units Dysport was administered by intramuscular injection into the clinically indicated neck muscles in a single dosing session in the first treatment cycle. This was the same dose as given in the preceding study NCT00257660 (Y-47-52120-051). Based on individual safety \& efficacy, subjects could then receive up to 3 subsequent injections with doses titrated in 250 unit steps, to a minimum of 250 units and a maximum of 1000 units. Retreatment occurred approximately 12-16 weeks after the previous injection, with the exact timing based on clinical need.

Arms:

Dysport

Other names:

AbobotulinumtoxinA (Dysport®)

Size

108

Primary endpoint

Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline

Week 4 follow-up visit

Eligibility criteria

Inclusion Criteria: * Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or up to Week 4 in the event of an early withdrawal * Returned to pre-treatment status as judged by the Investigator Exclusion Criteria: * Pure anterocollis or pure retrocollis * Known antibodies to botulinum toxin type A * Requirement for botulinum toxin injections to site(s) other than the neck and unable to avoid such treatment for the duration of the study * Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 108, 'type': 'ACTUAL'}}

Updated at

2022-09-28

1 organization

1 product

1 indication

Organization

Ipsen

Product

Botulinum toxin type A

Indication

Cervical Dystonia