A comparison of Dysport (100 U/ml) and Botox (100 U/ml) using dose conversion factor 3:1 and 1.7:1 in the treatment of cervical dystonia. - DysBot

• Conditions: Cervical dystonia, not multifocal or generalised dystonia.; MedDRA version: 9.1Level: LLTClassification code 10064124Term: Cervical dystonia

• Registration Number: EUCTR2008-005819-18-SE
• Lead Sponsor: Department of Neuroscience, Uppsala University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients who are 18 years of age or older with diagnosed cervical dystonia that has been treated with Dysport regularly for at least one year prior to the study with stabilised treatment response.
Signed informed consent must be obtained before any study-related procedures are conducted.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Contraindications to any of the investigational products, pregnancy or lactation, multifocal or generalised dystonia, patients with deep brain stimulation (DBS) treatment, patients with ongoing pronounced variability in daily bensodiazepine dose, = 2 mg clonazepam or corresponding doses of other bensodiazepines, patients suffering from other conditions that, in the opinion of the investigator, might interfere with the study objectives or patients that, in the opinion of the investigator, are unable to comply with study requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified