Open, multicentre study on the equivalent efficacy and safety of Botulinum toxin A (500 Units Dysport®) in the treatment of heterogeneous forms of cervical dystonia

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-002086-20

Femme et Homme

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Extrait

The results of a dose finding study have shown that 500 units Dysport® are the optimal starting dose for the treatment of patients with rotational torticollis. Although Dysport is an established first-line neurological treatment for cervical dystonia since its registration in Germany in 1995, there are only little data available on dose, efficacy and safety in the treatment of heterogeneous forms of cervical dystonia. The aim of this multicentre open study is to demonstrate the equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units Dysport.


Critère d'inclusion

  • Cervical dystonia (CD), one of the most common forms of focal dystonia, is characterised by an altered head posture, pain in the the neck and shoulder region and hypertrophy of the concerned muscles. Over the past 15 years local injections of botulinum toxin into various neck muscles have become the first line therapeutic approach

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