Open-label Extension Study of AbobotulinumtoxinA (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: abobotulinumtoxinA (Dysport) 250-1000 units	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Drug Information available for: Botulinum toxin A

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline [ Time Frame: Week 4 follow-up visit ] [ Designated as safety issue: No ]
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. For each treatment cycle, the change in TWSTRS total score is the score at week 4 minus the score at baseline.

Secondary Outcome Measures:

Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline [ Time Frame: Week 4 follow-up visit ] [ Designated as safety issue: No ]
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for severity is from 0 (absence of severity) to 35 (max severity). For each treatment cycle, the change in TWSTRS severity subscale is the score at week 4 minus the score at baseline.
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline [ Time Frame: Week 4 follow-up visit ] [ Designated as safety issue: No ]
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for disability is from 0 (no disability) to 30 (max disability). For each treatment cycle, the change in TWSTRS disability subscale is the score at week 4 minus the score at baseline.
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline [ Time Frame: Week 4 follow-up visit ] [ Designated as safety issue: No ]
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for pain is from 0 (no pain) to 20 (max pain). For each treatment cycle, the change in TWSTRS pain subscale is the score at week 4 minus the score at baseline.

Enrollment:	108
Study Start Date:	February 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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 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

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
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
USC School of Medicine
Los Angeles, California, United States, 90033
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
University of Texas Southwest Medical Center, Movement Disorder Clinic
Dallas, Texas, United States, 75309
Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic
Houston, Texas, United States, 77030
Russian Federation
Scientific Research Institute of Neurology, RAMS
Moscow, Russian Federation, 123367
Clinic "Cecil Plus"
Moscow, Russian Federation, 125047
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

Publications:

Truong D, Brodsky M, Lew M, Brashear A, Jankovic J, Molho E, Orlova O, Timerbaeva S; Global Dysport Cervical Dystonia Study Group. Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia. Parkinsonism Relat Disord. 2010 Jun;16(5):316-23. Epub 2010 Mar 31.

Responsible Party:	Jean-Loic Robin, Ipsen
ClinicalTrials.gov Identifier:	NCT00288509 History of Changes
Other Study ID Numbers:	Y-47-52120-731
Study First Received:	February 7, 2006
Results First Received:	January 6, 2010
Last Updated:	June 17, 2010
Health Authority:	United States: Food and Drug Administration; Russia: Ministry of Health and Social Development of the Russian Federation

Additional relevant MeSH terms:

Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012