NCT00723762 - 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)

Attilakos A, Voudris KA, Katsarou E, Prassouli A, Mastroyianni S, Garoufi A
Transient decrease in serum albumin concentrations in epileptic children treated with sodium valproate monotherapy. Clin Neuropharmacol. 2007 May-Jun;30(3):145-9.
Castro-Gago M, Rodrigo-Saez E, Novo-Rodriguez I, Camiña MF, Rodriguez-Segade S
Hyperaminoacidemia in epileptic children treated with valproic acid. Childs Nerv Syst. 1990 Dec;6(8):434-6.
Hauser E, Seidl R, Freilinger M, Male C, Herkner K
Hematologic manifestations and impaired liver synthetic function during valproate monotherapy. Brain Dev. 1996 Mar-Apr;18(2):105-9.
Karikas GA, Schulpis KH, Bartzeliotou A, Karakonstantakis T, Georgala S, Kanavaki I, Demetriou E, Papassotiriou I
Lipids, lipoproteins, apolipoproteins, selected trace elements and minerals in the serum of children on valproic acid monotherapy. Basic Clin Pharmacol Toxicol. 2006 Jun;98(6):599-603.
Oratz M, Rothschild MA, Schreiber SS, Burks A, Mongelli J, Matarese B
The role of the urea cycle and polyamines in albumin synthesis. Hepatology. 1983 Jul-Aug;3(4):567-71.
Rugino TA, Janvier YM, Baunach JM, Bilat CA
Hypoalbuminemia with valproic acid administration. Pediatr Neurol. 2003 Nov;29(5):440-4.

Valproic Acid-associated Hypoalbuminemia in Medically Fragile Pediatric and Young Adult Patients in a Long Term Care Facility Part 1: Potential Mechanism for Decreased Albumin Synthesis

Details for clinical trial NCT00723762

Clinical trial NCT00723762 - References