Phase 4
N=102
A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia
Cervical Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT00950664 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Reduction of Total Tsui Score at 4 Weeks From Baseline — -3.98; -4.77 units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dysport® (abobotulinumtoxinA) (Drug); Botox® (onabotulinumtoxinA) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of Total Tsui Score at 4 Weeks From Baseline |
-3.98; -4.77 | 0.05 |
| SECONDARY Reduction of Total TWSTRS Score at 4 Weeks From Baseline |
-9.76; -8.78 | — |
| SECONDARY CGI-I (Clinical Global Impression of Illness) |
16.0; 13.8; 16.0; 14.9; 11.7; 14.9 | — |
| SECONDARY PGI-I (Patient's Global Impression of Improvement) |
35.1; 36.2; 33.0; 36.2; 20.2; 27.7 | — |
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
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.
Data sourced from ClinicalTrials.gov (NCT00950664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.