A Randomised Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia (CD). - Full Text View

Purpose

The purpose of the protocol is to evaluate the efficacy of Dysport using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.

Condition	Intervention	Phase
Cervical Dystonia	Drug: Dysport Drug: Placebo, Up to 2mL	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia.

Resource links provided by NLM:

Genetics Home Reference related topics: dopa-responsive dystonia early-onset primary dystonia

MedlinePlus related topics: Botox Dystonia

Drug Information available for: OnabotulinumtoxinA

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score [ Time Frame: 4 weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in TWSTRS total score [ Time Frame: Baseline and 2 weeks post-treatment ] [ Designated as safety issue: No ]
Clinical Global Impression of Change (CGIC) in Cervical Dystonia [ Time Frame: 2 and 4 weeks post-treatment ] [ Designated as safety issue: No ]
Treatment response [ Time Frame: 2 and 4 weeks post-treatment ] [ Designated as safety issue: No ]
A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment.
Change in Cervical Dystonia Impact Profile-58 (CDIP-58) score [ Time Frame: 2 and 4 weeks post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	132
Study Start Date:	January 2013
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Dysport Dysport (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only	Drug: Dysport Dysport (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Placebo Comparator: Placebo Up to 2mL	Drug: Placebo, Up to 2mL

Eligibility

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

Criteria

Inclusion Criteria:

Primary diagnosis of Cervical Dystonia at least 18 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
TWSTRS total score≥ 30; TWSTRS-severity subscale score≥ 15; TWSTRS-disability subscale score ≥ 3; TWSTRS-pain subscale score ≥ 2

Exclusion Criteria:

In apparent remission from Cervical Dystonia
Diagnosis of pure retrocollis or pure anterocollis
For non-naïve subjects, previous poor response to either of the last two Botox treatments
Known requirement of <100U or >200U of Botox injected into the neck muscles

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753310

Contacts

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

Locations

United States, Colorado
Advanced Neurosciences Research	Not yet recruiting
Fort Collins, Colorado, United States, 80528
United States, Florida
Parkinson's & Movement Disorders Center of Boca Raton	Not yet recruiting
Boca Raton, Florida, United States, 33486
Emerald Coast Center for Neurological Disorders	Not yet recruiting
Pensacola, Florida, United States, 32514
PD Treatment Center of SW FL	Not yet recruiting
Port Charlotte, Florida, United States, 33980
Guilford Neurologic Associates	Not yet recruiting
West Palm Beach, Florida, United States, 33407
United States, Kansas
Kansas City Bone & Joint Clinic	Not yet recruiting
Kansas City, Kansas, United States, 66211
International Clinical Research Institute	Not yet recruiting
Overland Park, Kansas, United States, 66210
United States, New York
Kingston Neurological Associates	Recruiting
Kingston, New York, United States, 12401
Island Neurological Associates	Recruiting
Plainview, New York, United States, 11803
United States, South Carolina
Coastal Neurology	Not yet recruiting
Port Royal, South Carolina, United States, 29935
United States, Texas
North Texas Movement Disorders Institute	Not yet recruiting
Bedford, Texas, United States, 76201

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Wes Cetnarowski, M.D.

Ipsen

More Information

No publications provided

Responsible Party:	Ipsen
ClinicalTrials.gov Identifier:	NCT01753310 History of Changes
Other Study ID Numbers:	A-TL-52120-169
Study First Received:	December 17, 2012
Last Updated:	April 24, 2013
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 May 19, 2013