Conditions: Cervical Dystonia
Keywords: cervical dystonia botulinum toxin
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 103
Healthy volunteers: no

Brief summary:
1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia.
2. double blind, randomised, multi center, crossover study

Detailed description:
1. Prospective, randomized, head-to-head, double-blind, cross-over study.
2. Total patients: A group 51, B group 51
3. Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4 weeks of wash out period, then the patients get the other treatment (i.e, Patients who have got Dysport will be then administered with Botox)
4. Compare the TSUI change score from baseline to 4 weeks after injection.

Arms:
arm 1: Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA) arm 2: Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)

Interventions: intervention 1: Dysport® (abobotulinumtoxinA) intervention 2: Botox® (onabotulinumtoxinA)
Intervention descriptions: intervention 1: Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units intervention 2: Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units

Protocol document: