drugset / Trial / NCT00406367
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm
RandomizedParallel-groupDouble-blindTreatment
Summary
Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.
Timeline
- Start
- 2006-10
- Primary completion
- 2008-04
- Completion
- 2009-07
Outcome
Met primary endpoint
registry incobotulinumtoxinA (Xeomin) vs Placebo; p <0.001; Mean Difference (Final Values) -1.0 (95% CI -1.4 to -0.5); ANCOVA NCT00406367 ↗
paper favoring incobotulinumtoxinA by 1.0 point (95% CI [0.5-1.4]; P < .001). PMID 21520284 ↗
Publications
- Results Jankovic J, Comella C, Hanschmann A, Grafe S. Efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin) in the treatment of blepharospasm-a randomized trial. Mov Disord. 2011 Jul;26(8):1521-8. doi: 10.1002/mds.23658. Epub 2011 Apr 22.
- Results Truong DD, Gollomp SM, Jankovic J, LeWitt PA, Marx M, Hanschmann A, Fernandez HH; Xeomin US Blepharospasm Study Group. Sustained efficacy and safety of repeated incobotulinumtoxinA (Xeomin((R))) injections in blepharospasm. J Neural Transm (Vienna). 2013 Sep;120(9):1345-53. doi: 10.1007/s00702-013-0998-9. Epub 2013 Feb 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 50 iu | Intramuscular |