NCT02662530 - 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)

Brans JW, Lindeboom R, Snoek JW, Zwarts MJ, van Weerden TW, Brunt ER, van Hilten JJ, van der Kamp W, Prins MH, Speelman JD
Botulinum toxin versus trihexyphenidyl in cervical dystonia: a prospective, randomized, double-blind controlled trial. Neurology. 1996 Apr;46(4):1066-72.
Caleo M, Antonucci F, Restani L, Mazzocchio R
A reappraisal of the central effects of botulinum neurotoxin type A: by what mechanism? J Neurochem. 2009 Apr;109(1):15-24. doi: 10.1111/j.1471-4159.2009.05887.x. Epub 2009 Feb 11. Review.
Dressler D
Botulinum toxin for treatment of dystonia. Eur J Neurol. 2010 Jul;17 Suppl 1:88-96. doi: 10.1111/j.1468-1331.2010.03058.x.
Evidente VG, Pappert EJ
Botulinum toxin therapy for cervical dystonia: the science of dosing. Tremor Other Hyperkinet Mov (N Y). 2014 Nov 12;4:273. doi: 10.7916/D84X56BF. eCollection 2014.
Evidente VG, Truong D, Jankovic J, Comella CL, Grafe S, Hanschmann A
IncobotulinumtoxinA (Xeomin®) injected for blepharospasm or cervical dystonia according to patient needs is well tolerated. J Neurol Sci. 2014 Nov 15;346(1-2):116-20. doi: 10.1016/j.jns.2014.08.004. Epub 2014 Aug 10.
Raez MB, Hussain MS, Mohd-Yasin F
Techniques of EMG signal analysis: detection, processing, classification and applications. Biol Proced Online. 2006;8:11-35. Epub 2006 Mar 23. Erratum in: Biol Proced Online. 2006;8():163.
Werdelin L, Dalager T, Fuglsang-Frederiksen A, Regeur L, Karlsborg M, Korbo L, Munck O, Winge K
The utility of EMG interference pattern analysis in botulinum toxin treatment of torticollis: a randomised, controlled and blinded study. Clin Neurophysiol. 2011 Nov;122(11):2305-9. doi: 10.1016/j.clinph.2011.04.012. Epub 2011 Jun 1.

Comparison of Clinical and Kinematic Assessment in the Determination of Botox® Injection Parameters in Cervical Dystonia Patients

Details for clinical trial NCT02662530

Clinical trial NCT02662530 - References