IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
Summary
At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period.
Timeline
- Start
- 2006-07
- Primary completion
- 2008-01
- Completion
- 2009-06
Outcome
Mixed primary results
registry incobotulinumtoxinA (Xeomin) (240 Units) vs Placebo; p <0.001; Mean Difference (Final Values) -9.0 (95% CI -12.0 to -5.9) NCT00407030 ↗
registry incobotulinumtoxinA (Xeomin) (120 Units) vs Placebo; p <0.001; Mean Difference (Final Values) -7.5 (95% CI -10.4 to -4.6) NCT00407030 ↗
registry incobotulinumtoxinA (Xeomin) (240 Units) vs incobotulinumtoxinA (Xeomin) (120 Units); p = 0.447; Mean Difference (Final Values) 1.3 (95% CI -2.1 to 4.6) NCT00407030 ↗
Publications
- Results Comella CL, Jankovic J, Truong DD, Hanschmann A, Grafe S; U.S. XEOMIN Cervical Dystonia Study Group. Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN(R), botulinum neurotoxin type A, without accessory proteins) in patients with cervical dystonia. J Neurol Sci. 2011 Sep 15;308(1-2):103-9. doi: 10.1016/j.jns.2011.05.041. Epub 2011 Jul 18.
- Results Evidente VG, Fernandez HH, LeDoux MS, Brashear A, Grafe S, Hanschmann A, Comella CL. A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin((R))) in cervical dystonia. J Neural Transm (Vienna). 2013 Dec;120(12):1699-707. doi: 10.1007/s00702-013-1048-3. Epub 2013 Jun 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 120 iu | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 240 iu | Intramuscular |