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

Cervical Dystonia Clinical Trial

Official title:

A Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® (abobotulinumtoxinA) in the Clinical Efficacy and Safety in Comparison With Botox®(onabotulinumtoxinA), Assuming a Bioequivalence Ratio of 2.5:1 Units, in the Treatment of Cervical Dystonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950664
• Other study ID #: H-0902-049-272
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2009
• Last updated: August 5, 2013
• Start date: August 2009
• Est. completion date: July 2011

Study information

• Verified date: August 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: July 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Intervention

Drug:
• Dysport® (abobotulinumtoxinA)
Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
• Botox® (onabotulinumtoxinA)
Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Bundang Seoul Natiuonal University Hospital	Seongnam	Gyeong-gi
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Boramae City Hospital	Seoul
Korea, Republic of	Hanyang University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ipsen, Medical Research Collaborating Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduction of Tsui Score at Each Visit From Baseline	Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.	4, 8, 12 and 16 weeks after injection	No
Other	Reduction of Total TWSTRS at Each Visit From Baseline	TWSTRS scale (Toronto western spasmodic torticollis rating scale, range: 0-80, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of TWSTRS scale.	4, 8, 12 and 16 weeks after injection	No
Other	Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline	Pain subscale of TWSTRS scale.(Range: 0-20) Negative numbers to represent decreases of TWSTRS pain subscale.	4, 8, 12 and 16 weeks after injection	No
Primary	Reduction of Total Tsui Score at 4 Weeks From Baseline	Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.	4 weeks after injection from baseline	No
Secondary	Reduction of Total TWSTRS Score at 4 Weeks From Baseline	TWSTRS (Toronto western spasmodic torticollis rating scale) (range: 0-80, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of TWSTRS.	4 weeks after injection from baseline	No
Secondary	CGI-I (Clinical Global Impression of Illness)	The proportion of patients with 'normal/ not at all ill' or 'borderline mildly ill' on the CGI (Clinical global impression of illness, CGI-I); 1 = normal / not at all ill'; 2 = 'borderline mildly ill'; 3 = 'mildly ill'; 4 = 'moderlately ill'; 5 = 'markedly ill'; 6 = 'severely ill'; 7 = 'the most extremely ill'.	4, 8, 12 and 16 weeks after injection	No
Secondary	PGI-I (Patient's Global Impression of Improvement)	The proportion of patients with 'very much improved' or 'much improved' on the PGI (Patient's global impression of impairment, PGI-I); 1 = very much improved, 2= much improved, 3 = slightly improved, 4 = no change, 5 = slightly aggravated, 6 = much aggravated, and 7 = very much aggravated	4, 8, 12 and 16 weeks after injection	No