Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia - Full Text View

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00257660

Purpose

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.

Condition	Intervention	Phase
Cervical Dystonia	Drug: Botulinum type A toxin (Dysport®) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for 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:

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Baseline and Week 4 ] [ 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. 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 (TWSTRS) [ Time Frame: Baseline and Week 8 ] [ 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. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score [ Time Frame: Baseline and Week 12 ] [ 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. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Investigator VAS for CD Symptom Assessment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Subject VAS for CD Symptom Assessment [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).
Investigator's VAS for CD Symptom Assessment [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Subject VAS for CD Symptom Assessment [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Investigator's VAS for CD Symptom Assessment [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
SF-36 Mental Health Summary Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).
SF-36 Physical Health Summary Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).
Number of Participants Considered by the Investigator to be Overall Treatment Successes [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.

Enrollment:	116
Study Start Date:	October 2005
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Drug: abobotulinumtoxinA (Dysport®)	Drug: Botulinum type A toxin (Dysport®) 500 units
Placebo Comparator: 2 Placebo	Drug: Placebo 500 units

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257660

Locations

United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
United States, California
Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States
USC School of Medicine
Los Angeles, California, United States, 90033
United States, Florida
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
United States, Georgia
Emory University
Atlanta, Georgia, United States
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States
United States, Iowa
University of Iowa
Iowa City, Iowa, United States
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States
United States, Michigan
Wayne State University Medical Center
Southfield, Michigan, United States
United States, New York
Albany Medical Center
Albany, New York, United States
Columbia University
New York, New York, United States
Beth Israel Medical Center
New York, New York, United States, 10003
United States, North Carolina
Wake Forest University
Winston Salem, North Carolina, United States
United States, Pennsylvania
Allegeheny General
Pittsburgh, Pennsylvania, United States
United States, Texas
University of Texas Southwest
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
United States, Washington
Swedish Neuroscience
Seattle, Washington, United States
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

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:	NCT00257660 History of Changes
Other Study ID Numbers:	Y-47-52120-051
Study First Received:	November 22, 2005
Results First Received:	January 6, 2010
Last Updated:	June 17, 2010
Health Authority:	United States: Food and Drug Administration

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