Trial record 1 of 1 for:    A-TL-52120-170
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An Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport In Adults With Cervical Dystonia (CD)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01753336
First received: December 17, 2012
Last updated: August 21, 2014
Last verified: August 2014
  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:


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: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Movement Disorders Center of Arizona, LLC
Scottsdale, Arizona, United States, 85258
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
East Bay Physician's Group
Berkeley, California, United States, 94705
Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
Loma Linda University Healthcare, Department of Neurology
Loma Linda, California, United States, 92354
USC Keck School of Medicine
Los Angeles, California, United States, 90033
UC Davis Medical Center
Sacramento, California, United States, 95817
Sutter Cancer Center
Sacramento, California, United States, 95816
United States, Colorado
Advanced Neurosciences Research
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Associated Neurologist of Southern CT, PC
Fairfield, Connecticut, United States, 06824
Yale Medical Group, Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States, 32607
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, United States, 32514
Parkinson's Treatment Center of SW Florida
Port Charlotte, Florida, United States, 33980
USF HealthParkinson's Disease and Movement Disorders Center
Tampa, Florida, United States, 33613
Guilford Neurologic Associates
West Palm Beach, Florida, United States, 33407
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States, 33407
United States, Georgia
NeuroTrials Research Inc.
Atlanta, Georgia, United States, 30342
Emory University
Atlanta, Georgia, United States, 30329
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States
United States, Kansas
Kansas City Bone & Joint Clinic
Kansas City, Kansas, United States, 66211
International Clinical Research Institute
Overland Park, Kansas, United States, 66210
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
Rehabilitation Consultants, PA
Eagan, Minnesota, United States, 55121
United States, New Jersey
University of Medicine and Dentistry of New Jersey
Stratford, New Jersey, United States, 08084
Atlantic Neuroscience Institute
Summit, New Jersey, United States, 07901
United States, New York
Kingston Neurological Associates
Kingston, New York, United States, 12401
The Ichan School of Medicine at Mount Sinai
New York, New York, United States, 10029
Island Neurological Associates
Plainview, New York, United States, 11803
United States, North Carolina
Guilford Neurologic Associates; Cone Health Medical Group
Greensboro, North Carolina, United States, 27405
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati Physicians Company, LLC
Cincinnati, Ohio, United States, 45267
United States, Oregon
OHSU Center for Health and Healing
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Hershey Neurology
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Coastal Neurology, PA
Port Royal, South Carolina, United States, 29935
United States, Texas
North Texas Movement Disorders Institute
Bedford, Texas, United States, 76201
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Puget Sound Neurology
Tacoma, Washington, United States, 98409
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Kathleen G Lomax, 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: August 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Central Nervous System Diseases
Dyskinesias
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014