Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia
NCT ID: NCT01753336
Last Updated: 2019-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
112 participants
INTERVENTIONAL
2013-03-31
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dysport®
Dysport®, up to 500 units (U)/vial using 2mL dilution
Botulinum toxin type A
Dysport® (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles
Interventions
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Botulinum toxin type A
Dysport® (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Requirement for Botulinum Neurotoxin (BoNT) 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 BoNT or related compounds, or any component in the study drug formulation
* Allergy to cow's milk protein
* Myasthenia gravis, other disease of the neuromuscular junction or clinically significant, persistent neuromuscular weakness, or disease or symptoms that could interfere 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 deep brain stimulation to treat CD
* Cervical contracture that limited passive range of motion
* Physiotherapy initiated \<4 weeks before study entry or expected to be initiated during the study
* Treatment with aminoglycoside antibiotics within 30 days prior to study treatment
* Current or expected requirement for concomitant medication that could interfere with the evaluation of study treatment
* Pregnant and/or lactating females
* Females of childbearing potential with a positive prestudy urine pregnancy test (a positive urine pregnancy test could be confirmed by a serum pregnancy test at the discretion of the investigator) and subjects, or their partners, who did not agree to use adequate contraception (hormonal or barrier method of birth control) prior to injection of study treatment and for the duration of study participation. Nonchildbearing potential is defined as postmenopause for at least 1 year, surgical sterilisation at least 3 months before entering the study, or hysterectomy
* Individuals who had family or employee relationship to study site staff or sponsor staff involved in the conduct of the study
* Any medical condition that could, as judged by the investigator, compromise compliance with the objectives and procedures of this protocol or preclude the administration of BoNT, including swallowing and other respiratory abnormality.
* Subjects who were unable and/or unwilling to comply fully with the protocol and the study instructions, as judged by the investigator
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director Neurology, M.D.
Role: STUDY_DIRECTOR
Ipsen
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Movement Disorders Center of Arizona, LLC
Scottsdale, Arizona, United States
University of Arizona
Tucson, Arizona, United States
East Bay Physician's Group
Berkeley, California, United States
Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States
Loma Linda University Healthcare, Department of Neurology
Loma Linda, California, United States
USC Keck School of Medicine
Los Angeles, California, United States
Sutter Cancer Center
Sacramento, California, United States
UC Davis Medical Center
Sacramento, California, United States
Advanced Neurosciences Research
Fort Collins, Colorado, United States
Associated Neurologist of Southern CT, PC
Fairfield, Connecticut, United States
Yale Medical Group, Yale University
New Haven, Connecticut, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, United States
Parkinson's Treatment Center of SW Florida
Port Charlotte, Florida, United States
USF HealthParkinson's Disease and Movement Disorders Center
Tampa, Florida, United States
Guilford Neurologic Associates
West Palm Beach, Florida, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
NeuroTrials Research Inc.
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Kansas City Bone & Joint Clinic
Kansas City, Kansas, United States
International Clinical Research Institute
Overland Park, Kansas, United States
Tufts Medical Center
Boston, Massachusetts, United States
Rehabilitation Consultants, PA
Eagan, Minnesota, United States
University of Medicine and Dentistry of New Jersey
Stratford, New Jersey, United States
Atlantic Neuroscience Institute
Summit, New Jersey, United States
Kingston Neurological Associates
Kingston, New York, United States
The Ichan School of Medicine at Mount Sinai
New York, New York, United States
Island Neurological Associates
Plainview, New York, United States
Guilford Neurologic Associates; Cone Health Medical Group
Greensboro, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
University of Cincinnati Physicians Company, LLC
Cincinnati, Ohio, United States
OHSU Center for Health and Healing
Portland, Oregon, United States
Penn State Hershey Neurology
Hershey, Pennsylvania, United States
Coastal Neurology, PA
Port Royal, South Carolina, United States
North Texas Movement Disorders Institute
Bedford, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Puget Sound Neurology
Tacoma, Washington, United States
Countries
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References
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Dashtipour K, Wietek S, Rubin B, Maisonobe P, Bahroo L, Trosch R. AbobotulinumtoxinA using 2-mL dilution (500 U/2-mL) maintains durable improvement across multiple treatment cycles. J Clin Mov Disord. 2020 Aug 31;7:8. doi: 10.1186/s40734-020-00090-x. eCollection 2020.
Related Links
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Other Identifiers
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A-TL-52120-170
Identifier Type: -
Identifier Source: org_study_id
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