NCT00086281 - 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)

A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy
Sleep. 2003 Feb 1;26(1):31-5.
A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy
Sleep. 2002 Feb 1;25(1):42-9.
The abrupt cessation of therapeutically administered sodium oxybate (GHB) does not cause withdrawal symptoms
J Toxicol Clin Toxicol. 2003;41(2):131-5.
U
S. Xyrem Multicenter Study Group. Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. Sleep Med. 2004 Mar;5(2):119-23.

Randomized, Placebo-Controlled Multicenter Trial of the Effects of Orally Administered Xyrem (Sodium Oxybate) and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients

Details for clinical trial NCT00086281

Clinical trial NCT00086281 - References