NCT00021697 - 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)

Brooks BR, Crumpacker D, Fellus J, Kantor D, Kaye RE
PRISM: a novel research tool to assess the prevalence of pseudobulbar affect symptoms across neurological conditions. PLoS One. 2013 Aug 21;8(8):e72232. doi: 10.1371/journal.pone.0072232. eCollection 2013.
Brooks BR, Thisted RA, Appel SH, Bradley WG, Olney RK, Berg JE, Pope LE, Smith RA; AVP-923 ALS Study Group
Treatment of pseudobulbar affect in ALS with dextromethorphan/quinidine: a randomized trial. Neurology. 2004 Oct 26;63(8):1364-70.
Dark FL, McGrath JJ, Ron MA
Pathological laughing and crying. Aust N Z J Psychiatry. 1996 Aug;30(4):472-9. Review.
Gallagher JP
Pathologic laughter and crying in ALS: a search for their origin. Acta Neurol Scand. 1989 Aug;80(2):114-7.
Moore SR, Gresham LS, Bromberg MB, Kasarkis EJ, Smith RA
A self report measure of affective lability. J Neurol Neurosurg Psychiatry. 1997 Jul;63(1):89-93.
Müller U, Murai T, Bauer-Wittmund T, von Cramon DY
Paroxetine versus citalopram treatment of pathological crying after brain injury. Brain Inj. 1999 Oct;13(10):805-11.
Schadel M, Wu D, Otton SV, Kalow W, Sellers EM
Pharmacokinetics of dextromethorphan and metabolites in humans: influence of the CYP2D6 phenotype and quinidine inhibition. J Clin Psychopharmacol. 1995 Aug;15(4):263-9.
Smith RA, Moore SR, Gresham LS, Manley PE, Licht JM: The treatment of affective lability with dextromethorphan
Neurology 54: 604P, 1995
Wolf JK, Santana HB, Thorpy M
Treatment of "emotional incontinence" with levodopa. Neurology. 1979 Oct;29(10):1435-6.

A Double-Blind Controlled, Multicenter Phase II/III Study to Assess the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect in Patients With Amyotrophic Lateral Sclerosis

Details for clinical trial NCT00021697

Clinical trial NCT00021697 - References