drugset / Trial / NCT00288509
Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
NaSingle-groupOpen-labelTreatment
Summary
The aim of this study is to assess longer term safety and effectiveness of Dysport®.
Timeline
- Start
- 2006-02
- Primary completion
- 2008-01
- Completion
- 2008-01
Outcome
Met primary endpoint
paper Dysport produced a significant decrease from baseline in mean (+/-SE) TWSTRS total scores compared with placebo at Week 4 (primary efficacy endpoint; PMID 20359934 ↗
paper -15.6 +/- 2.0 vs. -6.7 +/- 2.0; p < 0.001 PMID 20359934 ↗
Publications
- Results Truong D, Brodsky M, Lew M, Brashear A, Jankovic J, Molho E, Orlova O, Timerbaeva S; Global Dysport Cervical Dystonia Study Group. Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia. Parkinsonism Relat Disord. 2010 Jun;16(5):316-23. doi: 10.1016/j.parkreldis.2010.03.002. Epub 2010 Mar 31.
- Mordin M, Masaquel C, Abbott C, Copley-Merriman C. Factors affecting the health-related quality of life of patients with cervical dystonia and impact of treatment with abobotulinumtoxinA (Dysport): results from a randomised, double-blind, placebo-controlled study. BMJ Open. 2014 Oct 16;4(10):e005150. doi: 10.1136/bmjopen-2014-005150.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 250 iu | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 500 iu | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 750 iu | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 1000 iu | Intramuscular |