Phase
Condition
Dystonia
Dyskinesias
Neck Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects enrolled in Study 169 that have no ongoing adverse events, which in theopinion of the Investigator are related to study treatment and that precludes themfrom receiving continuing therapy
Completed Study 169, or completed all study visits up to and including Week 4 and inthe event of an early withdrawal after Week 4 have ≤15% reduction in TWSTRS totalscore at Week 4 compared to their baseline TWSTRS total score in the double-blindstudy, and in the Investigator's clinical judgment, would benefit from Dysport® for CD
Exclusion
Exclusion Criteria:
Diagnosis of pure retrocollis or pure anterocollis
Requirement for Botulinum Neurotoxin (BoNT) injection to site(s) for disorders otherthan CD and unable to avoid such treatment(s) for the duration of the study
Known hypersensitivity to BoNT or related compounds, or any component in the studydrug formulation
Allergy to cow's milk protein
Myasthenia gravis, other disease of the neuromuscular junction or clinicallysignificant, persistent neuromuscular weakness, or disease or symptoms that couldinterfere with the TWSTRS scoring
Total body weight <95 lbs (43.09 kg)
Previous phenol injections to the neck muscles
Previous myotomy or denervation surgery involving the neck or shoulder region or deepbrain stimulation to treat CD
Cervical contracture that limited passive range of motion
Physiotherapy initiated <4 weeks before study entry or expected to be initiated duringthe study
Treatment with aminoglycoside antibiotics within 30 days prior to study treatment
Current or expected requirement for concomitant medication that could interfere withthe evaluation of study treatment
Pregnant and/or lactating females
Females of childbearing potential with a positive prestudy urine pregnancy test (apositive urine pregnancy test could be confirmed by a serum pregnancy test at thediscretion of the investigator) and subjects, or their partners, who did not agree touse adequate contraception (hormonal or barrier method of birth control) prior toinjection of study treatment and for the duration of study participation.Nonchildbearing potential is defined as postmenopause for at least 1 year, surgicalsterilisation at least 3 months before entering the study, or hysterectomy
Individuals who had family or employee relationship to study site staff or sponsorstaff involved in the conduct of the study
Any medical condition that could, as judged by the investigator, compromise compliancewith the objectives and procedures of this protocol or preclude the administration ofBoNT, including swallowing and other respiratory abnormality.
Subjects who were unable and/or unwilling to comply fully with the protocol and thestudy instructions, as judged by the investigator
Study Design
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Movement Disorders Center of Arizona, LLC
Scottsdale, Arizona 85258
United StatesSite Not Available
University of Arizona
Tucson, Arizona 85724
United StatesSite Not Available
East Bay Physician's Group
Berkeley, California 94705
United StatesSite Not Available
Parkinson's and Movement Disorder Institute
Fountain Valley, California 92708
United StatesSite Not Available
Loma Linda University Healthcare, Department of Neurology
Loma Linda, California 92354
United StatesSite Not Available
USC Keck School of Medicine
Los Angeles, California 90033
United StatesSite Not Available
Sutter Cancer Center
Sacramento, California 95816
United StatesSite Not Available
UC Davis Medical Center
Sacramento, California 95817
United StatesSite Not Available
Advanced Neurosciences Research
Fort Collins, Colorado 80528
United StatesSite Not Available
Associated Neurologist of Southern CT, PC
Fairfield, Connecticut 06824
United StatesSite Not Available
Yale Medical Group, Yale University
New Haven, Connecticut 06520
United StatesSite Not Available
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida 33486
United StatesSite Not Available
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida 32607
United StatesSite Not Available
Emerald Coast Center for Neurological Disorders
Pensacola, Florida 32514
United StatesSite Not Available
Parkinson's Treatment Center of SW Florida
Port Charlotte, Florida 33980
United StatesSite Not Available
USF HealthParkinson's Disease and Movement Disorders Center
Tampa, Florida 33613
United StatesSite Not Available
Guilford Neurologic Associates
West Palm Beach, Florida 33407
United StatesSite Not Available
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida 33407
United StatesSite Not Available
Emory University
Atlanta, Georgia 30329
United StatesSite Not Available
NeuroTrials Research Inc.
Atlanta, Georgia 30342
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Kansas City Bone & Joint Clinic
Kansas City, Kansas 66211
United StatesSite Not Available
International Clinical Research Institute
Overland Park, Kansas 66210
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
Rehabilitation Consultants, PA
Eagan, Minnesota 55121
United StatesSite Not Available
University of Medicine and Dentistry of New Jersey
Stratford, New Jersey 08084
United StatesSite Not Available
Atlantic Neuroscience Institute
Summit, New Jersey 07901
United StatesSite Not Available
Kingston Neurological Associates
Kingston, New York 12401
United StatesSite Not Available
The Ichan School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Island Neurological Associates
Plainview, New York 11803
United StatesSite Not Available
Guilford Neurologic Associates; Cone Health Medical Group
Greensboro, North Carolina 27405
United StatesSite Not Available
Wake Forest School of Medicine
Winston-Salem, North Carolina 27157
United StatesSite Not Available
University of Cincinnati Physicians Company, LLC
Cincinnati, Ohio 45267
United StatesSite Not Available
OHSU Center for Health and Healing
Portland, Oregon 97239
United StatesSite Not Available
Penn State Hershey Neurology
Hershey, Pennsylvania 17033
United StatesSite Not Available
Coastal Neurology, PA
Port Royal, South Carolina 29935
United StatesSite Not Available
Siskin Spine and Rehab
Chattanooga, Tennessee
United StatesSite Not Available
North Texas Movement Disorders Institute
Bedford, Texas 76201
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesSite Not Available
Puget Sound Neurology
Tacoma, Washington 98409
United StatesSite Not Available
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