NCT02494102 - 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)

Arnulf I, Homeyer P, Garma L, Whitelaw WA, Derenne JP
Modafinil in obstructive sleep apnea-hypopnea syndrome: a pilot study in 6 patients. Respiration. 1997;64(2):159-61.
Galvin E, Boesjes H, Hol J, Ubben JF, Klein J, Verbrugge SJ
Modafinil reduces patient-reported tiredness after sedation/analgesia but does not improve patient psychomotor skills. Acta Anaesthesiol Scand. 2010 Feb;54(2):154-61. doi: 10.1111/j.1399-6576.2009.02093.x. Epub 2009 Aug 31.
Jasinski DR, Kovacevic-Ristanovic R
Evaluation of the abuse liability of modafinil and other drugs for excessive daytime sleepiness associated with narcolepsy. Clin Neuropharmacol. 2000 May-Jun;23(3):149-56. Review.
Jasinski DR
An evaluation of the abuse potential of modafinil using methylphenidate as a reference. J Psychopharmacol. 2000 Mar;14(1):53-60.
Larijani GE, Goldberg ME, Hojat M, Khaleghi B, Dunn JB, Marr AT
Modafinil improves recovery after general anesthesia. Anesth Analg. 2004 Apr;98(4):976-81, table of contents.
Minzenberg MJ, Carter CS
Modafinil: a review of neurochemical actions and effects on cognition. Neuropsychopharmacology. 2008 Jun;33(7):1477-502. Epub 2007 Aug 22. Review.
Moldofsky H, Broughton RJ, Hill JD
A randomized trial of the long-term, continued efficacy and safety of modafinil in narcolepsy. Sleep Med. 2000 Apr 1;1(2):109-116.
Pack AI, Black JE, Schwartz JR, Matheson JK
Modafinil as adjunct therapy for daytime sleepiness in obstructive sleep apnea. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1675-81.
Wisor JP, Nishino S, Sora I, Uhl GH, Mignot E, Edgar DM
Dopaminergic role in stimulant-induced wakefulness. J Neurosci. 2001 Mar 1;21(5):1787-94.

A Randomized, Double Blind, Placebo Controlled Evaluation of Modafinil vs Placebo for the Treatment of General Anesthesia Related Delayed Emergence in Patients With the Diagnosis of Obstructive Sleep Apnea

Details for clinical trial NCT02494102

Clinical trial NCT02494102 - References