Clinical trial NCT00950664: A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia
Official title: A Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® in Comparison With Botox®, Assuming a Bioequivalence Ratio of 2.5:1 Units, in the Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Dystonia
Keywords: cervical dystonia
botulinum toxin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ipsen
name: Medical Research Collaborating Center, Seoul, Korea
First posted: 2009-08-03
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Reduction of Total Tsui Score at 4 Weeks From Baseline
timeFrame: 4 weeks after injection from baseline
Secondary outcomes:
measure: Reduction of Total TWSTRS Score at 4 Weeks From Baseline
timeFrame: 4 weeks after injection from baseline
measure: CGI-I (Clinical Global Impression of Illness)
timeFrame: 4, 8, 12 and 16 weeks after injection
measure: PGI-I (Patient's Global Impression of Improvement)
timeFrame: 4, 8, 12 and 16 weeks after injection
Other outcomes:
measure: Reduction of Tsui Score at Each Visit From Baseline
timeFrame: 8, 12 and 16 weeks after injection
measure: Reduction of Total TWSTRS at Each Visit From Baseline
timeFrame: 8, 12 and 16 weeks after injection
measure: Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline
timeFrame: 4, 8, 12 and 16 weeks after injection
Locations:
city: Seongnam
country: Korea, Republic of
facility: Bundang Seoul Natiuonal University Hospital
state: Gyeong-gi
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Boramae City Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Beom S Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yun JY, Kim JW, Kim HT, Chung SJ, Kim JM, Cho JW, Lee JY, Lee HN, You S, Oh E, Jeong H, Kim YE, Kim HJ, Lee WY, Jeon BS. Dysport and Botox at a ratio of 2.5:1 units in cervical dystonia: a double-blind, randomized study. Mov Disord. 2015 Feb;30(2):206-13. doi: 10.1002/mds.26085. Epub 2014 Dec 5.