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

Ipsen

Status and phase

Completed

Phase 3

Conditions

Cervical Dystonia

Treatments

Biological: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT01753336

A-TL-52120-170

Details and patient eligibility

About

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).

Enrollment

112 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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