NCT03044080 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Dressler D
Five-year experience with incobotulinumtoxinA (Xeomin(®) ): the first botulinum toxin drug free of complexing proteins. Eur J Neurol. 2012 Mar;19(3):385-9. doi: 10.1111/j.1468-1331.2011.03559.x. Epub 2011 Oct 28. Review.
Foley N, Murie-Fernandez M, Speechley M, Salter K, Sequeira K, Teasell R
Does the treatment of spastic equinovarus deformity following stroke with botulinum toxin increase gait velocity? A systematic review and meta-analysis. Eur J Neurol. 2010 Dec;17(12):1419-27. doi: 10.1111/j.1468-1331.2010.03084.x. Review.
Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH
Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. Epub 2003 Dec 18.
Watkins CL, Leathley MJ, Gregson JM, Moore AP, Smith TL, Sharma AK
Prevalence of spasticity post stroke. Clin Rehabil. 2002 Aug;16(5):515-22.

Effects of Repeated Use of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot in Stroke Patients: A Randomized Clinical Trial

Details for clinical trial NCT03044080

Clinical trial NCT03044080 - References