Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Botulinum toxin type A
Intervention description: Dysport® (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility 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 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