Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia

Completed · Phase 3

Conditions studied: Cervical Dystonia

In brief

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. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).

Key facts

Study ID

NCT01753336

Run by

Ipsen

People needed

112

Starts

2013-03-01

Expected to finish

2015-10-01

Last updated by the study team

2019-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Diagnosis of pure retrocollis or pure anterocollis
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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