Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS

Summary

The purpose of this study is to compare and evaluate the safety of AVP-923 (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.

Timeline

Start

2001-01

Primary completion

2002-04

Completion

2002-04

Outcome

Met primary endpoint

paper AVP-923 patients experienced 3.3-point greater improvements in CNS-LS than DM patients (p = 0.001) PMID 15505150 ↗

Publications

• Background Dark FL, McGrath JJ, Ron MA. Pathological laughing and crying. Aust N Z J Psychiatry. 1996 Aug;30(4):472-9. doi: 10.3109/00048679609065020.
• Background Smith RA, Moore SR, Gresham LS, Manley PE, Licht JM: The treatment of affective lability with dextromethorphan. Neurology 54: 604P, 1995
• Background Gallagher JP. Pathologic laughter and crying in ALS: a search for their origin. Acta Neurol Scand. 1989 Aug;80(2):114-7. doi: 10.1111/j.1600-0404.1989.tb03851.x.
• Background Wolf JK, Santana HB, Thorpy M. Treatment of "emotional incontinence" with levodopa. Neurology. 1979 Oct;29(10):1435-6. doi: 10.1212/wnl.29.10.1435-b. No abstract available.
• Background Muller 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. doi: 10.1080/026990599121197.
• Background 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. doi: 10.1136/jnnp.63.1.89.
• Background 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. doi: 10.1097/00004714-199508000-00005.
• Background 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.
• Results 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. doi: 10.1212/01.wnl.0000142042.50528.2f.

Drugs

Indications