Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.

Ipsen

Status and phase: Completed; Phase 3

Conditions: Cervical Dystonia

Treatments: Biological: Botulinum toxin type A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01753310

A-TL-52120-169

Details and patient eligibility

About

The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
• TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;

Exclusion criteria

• In apparent remission from Cervical Dystonia
• Diagnosis of pure retrocollis or pure anterocollis
• For non-naïve subjects, previous poor response to either of the last two Botox treatments
• Known requirement of <100U or >200U of Botox injected into the neck muscles

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups, including a placebo group

Dysport®

Active Comparator group

Description:

Dysport® (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only

Treatment:

Biological: Botulinum toxin type A

Placebo

Placebo Comparator group

Description:

Placebo, up to 2mL

Treatment:

Drug: Placebo