Open-Label Extension Study of Botulinum Type A Toxin (Dysport®) for the Treatment of Cervical Dystonia
Information source: Ipsen
Information obtained from ClinicalTrials.gov on August 03, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cervical Dystonia
Intervention: Botulinum type A toxin (Dysport®) - duration: maximum of 4 cycles/injections (Drug)
Phase: Phase 3
Status: No longer recruiting
Sponsored by: Ipsen Official(s) and/or principal investigator(s):
Jean-Loic Robin, MD, Study Director, Affiliation: Ipsen
Summary
The aim of this study is to assess longer term safety and effectiveness of Dysport® manufactured at a new manufacturing facility in Europe.
Clinical Details
Official title:
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
Study design: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Incidence of treatment emergent adverse events
Secondary outcome: Toronto Western Spasmodic Torticollis Rating Scale - Change from the start of each treatment cycle at 4 weeks post treatment
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or 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
Locations and Contacts
Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center, Phoenix, Arizona 85013, United States
USC School of Medicine, Los Angeles, California 90033, United States
The Parkinson's and Movement Disorder Institute, Fountain Valley, California 92708, United States
University of Florida, Dept of Neurology, Gainesville, Florida 32610, United States
University of Miami, Dept of Neurology, Miami, Florida 33136, United States
Emory University School of Medicine, Wesley Woods Health Center, Atlanta, Georgia 30329, United States
St Petersburg Pavlov State Medical University, St Petersburg 197022, Russian Federation
Scientific Research Institute of Neurology, RAMS, Moscow 123367, Russian Federation
Clinic "Cecil Plus", Moscow 125047, Russian Federation
Municipal Multi-Speciality Hospital #2, St Petersburg 194354, Russian Federation
University of Iowa, Dept of Neurology, Iowa City, Iowa 52242, United States
Wayne State University Medical Center, Southfield, Michigan 48034, United States
Albany Medical Center, Albany, New York 12205, United States
Beth Israel Medical Center, New York, New York 10003, United States
Columbia University Medical Center, Neurological Institute, New York, New York 10032, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States
Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic, Houston, Texas 77030, United States
University of Texas Southwest Medical Center, Movement Disorder Clinic, Dallas, Texas 75309, United States
Additional Information
Starting date:
February 2006
Ending date: September 2008
Last updated: July 23, 2007
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