Open-label Extension Study of Botulinum Type A Toxin (Dysport®) for the Treatment of Cervical Dystonia - Full Text View

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00288509

Purpose

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

Condition	Intervention	Phase
Cervical Dystonia	Drug: Botulinum type A toxin (Dysport) - duration: maximum of 4 cycles/injections	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Botox Dystonia

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

Change in TWSTRS total score from treatment cycle baseline [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

TWSTRS subscale scores as a change from baseline [ Time Frame: At every visit ] [ Designated as safety issue: No ]
Incidence of treatment emergent adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	February 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Dysport	Drug: Botulinum type A toxin (Dysport) - duration: maximum of 4 cycles/injections A fixed initial dose of 500 units Dysport, with subsequent injection doses titrated in 250 unit increments, to a minimum of 250 units and a maximum of 1000 units.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288509

Locations

United States, Arizona
Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
USC School of Medicine
Los Angeles, California, United States, 90033
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
United States, Florida
University of Florida, Dept of Neurology
Gainesville, Florida, United States, 32610
University of Miami, Dept of Neurology
Miami, Florida, United States, 33136
United States, Georgia
Emory University School of Medicine, Wesley Woods Health Center
Atlanta, Georgia, United States, 30329
United States, Iowa
University of Iowa, Dept of Neurology
Iowa City, Iowa, United States, 52242
United States, Michigan
Wayne State University Medical Center
Southfield, Michigan, United States, 48034
United States, New York
Albany Medical Center
Albany, New York, United States, 12205
Beth Israel Medical Center
New York, New York, United States, 10003
Columbia University Medical Center, Neurological Institute
New York, New York, United States, 10032
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic
Houston, Texas, United States, 77030
University of Texas Southwest Medical Center, Movement Disorder Clinic
Dallas, Texas, United States, 75309
Russian Federation
Clinic "Cecil Plus"
Moscow, Russian Federation, 125047
Scientific Research Institute of Neurology, RAMS
Moscow, Russian Federation, 123367
St Petersburg Pavlov State Medical University
St Petersburg, Russian Federation, 197022
Municipal Multi-Speciality Hospital #2
St Petersburg, Russian Federation, 194354

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Jean-Loic Robin, MD

Ipsen

More Information

No publications provided

Responsible Party:	Ipsen ( Jean-Loic Robin )
Study ID Numbers:	Y-47-52120-731
Study First Received:	February 7, 2006
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00288509 History of Changes
Health Authority:	United States: Food and Drug Administration; Russia: Ministry of Health and Social Development of the Russian Federation

Additional relevant MeSH terms:

Dystonic Disorders
Nervous System Diseases
Physiological Effects of Drugs
Dystonia
Central Nervous System Diseases
Neuromuscular Agents
Dyskinesias

Pharmacologic Actions
Signs and Symptoms
Torticollis
Movement Disorders
Neurologic Manifestations
Peripheral Nervous System Agents
Botulinum Toxin Type A

ClinicalTrials.gov processed this record on February 08, 2010