A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Ipsen; Medical Research Collaborating Center, Seoul, Korea
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Patients ≥ 18 years of age of both genders,

• Cervical dystonia

• symptoms with a minimum duration of 18 months,

• Negative pregnancy test in sexually active women,

• Able to participate in the study (understand goals of botulinum toxin A treatment and sign Informed Consent Form).

Exclusion Criteria:

• Patient with cervical contractures

• Known significant underlying dysphasia

• Patients who have received botulinum toxin treatment within the past 4 months.

• Contraindication to botulinum toxin treatment

• Any disease that might affect neuromuscular function (Myasthenia Gravis, Eaton-Lambert syndrome, ALS …)

• Patients who have received oral anti-spasticity medication, phenol therapy, myotomy or denervation surgery, deep brain stimulation for cervical dystonia,

• Patients who required more than 500 units of Dysport or 200 units of Botox.

• Any concomitant treatment that could interfere with the action of botulinum toxin,

• Subjects having participated within the last 3 months or currently participating in an investigational drug study,

• Pregnancy,

• Lactation.