Status:
COMPLETED
A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Ipsen
Medical Research Collaborating Center, Seoul, Korea
Conditions:
Cervical Dystonia
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
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. do...
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 baseli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00950664
Start Date
August 1 2009
End Date
July 1 2011
Last Update
July 5 2017
Active Locations (7)
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1
Bundang Seoul Natiuonal University Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-070
2
Dong-A University Hospital
Busan, South Korea, 602-715
3
Hanyang University Hospital
Seoul, South Korea, 133-792
4
Samsung Medical Center
Seoul, South Korea, 135-710