Infantile Spasms — Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms
Citation(s)
Arya R, Shinnar S, Glauser TA Corticosteroids for the treatment of infantile spasms: a systematic review. J Child Neurol. 2012 Oct;27(10):1284-8. Epub 2012 Aug 1. Review.
Ben-Menachem E Mechanism of action of vigabatrin: correcting misperceptions. Acta Neurol Scand Suppl. 2011;(192):5-15. doi: 10.1111/j.1600-0404.2011.01596.x. Review.
Hattori H Spontaneous remission of spasms in West syndrome--implications of viral infection. Brain Dev. 2001 Nov;23(7):705-7.
Hrachovy RA, Glaze DG, Frost JD Jr A retrospective study of spontaneous remission and long-term outcome in patients with infantile spasms. Epilepsia. 1991 Mar-Apr;32(2):212-4.
Jones K, Snead OC 3rd, Boyd J, Go C Adrenocorticotropic hormone versus prednisolone in the treatment of infantile spasms post vigabatrin failure. J Child Neurol. 2015 Apr;30(5):595-600. doi: 10.1177/0883073814533148. Epub 2014 Jun 25.
Kossoff EH, Hartman AL, Rubenstein JE, Vining EP High-dose oral prednisolone for infantile spasms: an effective and less expensive alternative to ACTH. Epilepsy Behav. 2009 Apr;14(4):674-6. doi: 10.1016/j.yebeh.2009.01.023. Epub 2009 Feb 4.
Rho JM Basic science behind the catastrophic epilepsies. Epilepsia. 2004;45 Suppl 5:5-11. Review.
Riikonen R Epidemiological data of West syndrome in Finland. Brain Dev. 2001 Nov;23(7):539-41. Review.
Simao GN, Zarei Mahmoodabadi S, Snead OC, Go C, Widjaja E Abnormal axial diffusivity in the deep gray nuclei and dorsal brain stem in infantile spasm treated with vigabatrin. AJNR Am J Neuroradiol. 2011 Jan;32(1):199-203. doi: 10.3174/ajnr.A2224. Epub 2010 Aug 26.
Zhang B, McDaniel SS, Rensing NR, Wong M Vigabatrin inhibits seizures and mTOR pathway activation in a mouse model of tuberous sclerosis complex. PLoS One. 2013;8(2):e57445. doi: 10.1371/journal.pone.0057445. Epub 2013 Feb 20.
Prednisolone vs. Vigabatrin in the First-line Treatment of Infantile Spasms
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
