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



Status:Completed
Conditions:Neurology, Orthopedic, Women's Studies
Therapuetic Areas:Neurology, Orthopedics / Podiatry, Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2013
End Date:October 2015

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A Phase IIIb, Prospective, Multicentre, Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport Using 2 mL Dilution In Adults With Cervical Dystonia

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).


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 toxin 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 botulinum toxin or related compounds, or any component in
the study drug formulation

- Allergy to cow's milk protein
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