An Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport In Adults With Cervical Dystonia (CD) - Full Text View

Purpose

The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia

Condition	Intervention	Phase
Cervical Dystonia	Drug: Dysport	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase IIIb, Prospective, Multicentre, Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport Using 2 mL 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 treatment cycle baseline (defined as Day 1 in each cycle) in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score [ Time Frame: Week 4 and Week 12 visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline (defined as the measurement before Dysport treatment in Study 169) in TWSTRS total score [ Time Frame: Week 4 and Week 12 visits ] [ Designated as safety issue: No ]
Treatment response in Treatment Cycle 3. [ Time Frame: Baseline and Week 4 visit ] [ Designated as safety issue: No ]
A treatment responder is defined as a subject who had at least a 30% reduction from baseline in the TWSTRS total score after treatment.
Change from treatment cycle baseline in TWSTRS severity subscale score [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
Change from treatment cycle baseline in TWSTRS disability subscale score [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
Change from treatment cycle baseline in TWSTRS pain subscale score [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2013
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dysport Dysport, up to 500 units (U)/vial using 2mL dilution	Drug: Dysport Dysport (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles

Eligibility

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

Criteria

Inclusion Criteria:

Subjects enrolled in Study 169 that have no ongoing adverse events, which in the opinion of the Investigator are related to study treatment and that precludes them from receiving continuing therapy
Completed Study 169, or completed all study visits up to and including Week 4 and in the event of an early withdrawal after Week 4 have ≤15% reduction in TWSTRS total score at Week 4 compared to their baseline TWSTRS total score in the double-blind study, and in the Investigator's clinical judgment, would benefit from Dysport for CD.

Exclusion Criteria:

Diagnosis of pure retrocollis or pure anterocollis
Requirement for botulinum toxin injection to site(s) for disorders other than CD and unable to avoid such treatment(s) for the duration of the study
Known hypersensitivity to botulinum toxin or related compounds, or any component in the study drug formulation
Allergy to cow's milk protein

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753336

Contacts

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

Locations

United States, Arizona
University of Arizona, Arizona	Not yet recruiting
Tucson, Arizona, United States
United States, California
USC Keck School of Medicine	Not yet recruiting
Los Angeles, California, United States
United States, Colorado
Advanced Neurosciences Research, LLC	Not yet recruiting
Fort Collins, Colorado, United States
United States, Florida
Parkinson's & Movement Disorders Center of Boca Raton	Not yet recruiting
Boca Raton, Florida, United States
Emerald Coast Center for Neurological Disorders	Not yet recruiting
Pensacola, Florida, United States
PD Treatment Center of SW FL	Not yet recruiting
Port Charlotte, Florida, United States
United States, Georgia
Atlanta Neurology	Not yet recruiting
Atlanta, Georgia, United States
United States, Kansas
Kansas City Bone & Joint Clinic, P.A.	Not yet recruiting
Kansas City, Kansas, United States
International Clinical Research Institute	Not yet recruiting
Overland Park, Kansas, United States
United States, Minnesota
Rehabilitation Consultants, PA	Not yet recruiting
Eagan, Minnesota, United States
United States, New York
Kingston Neurological Associates	Not yet recruiting
Kingston, New York, United States
Mount Siani	Not yet recruiting
New York, New York, United States
Island Neurologic Associates	Not yet recruiting
Plainview, New York, United States
United States, North Carolina
Guilford Neurologic Associates	Not yet recruiting
Greensboro, North Carolina, United States
United States, Pennsylvania
Penn State Hershey Neurology	Not yet recruiting
Hershey, Pennsylvania, United States
United States, South Carolina
Coastal Neurology, PA	Not yet recruiting
Port Royal, South Carolina, United States
United States, Tennessee
Siskin Spine and Rehab	Not yet recruiting
Chattanooga, Tennessee, United States
United States, Texas
North Texas Movement Disorders Institute	Not yet recruiting
Bedford, Texas, United States

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Eric First, M.D.

Ipsen

More Information

No publications provided

Responsible Party:	Ipsen
ClinicalTrials.gov Identifier:	NCT01753336 History of Changes
Other Study ID Numbers:	A-TL-52120-170
Study First Received:	December 17, 2012
Last Updated:	March 31, 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 23, 2013