A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy

Phase 2/3 Completed 451 enrolled UCB Pharma

NaSingle-groupOpen-labelTreatment

Summary

Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.

Timeline

Start: 2004-09
Primary completion: 2008-07
Completion: 2008-07

Publications

Shaibani A, Biton V, Rauck R, Koch B, Simpson J. Long-term oral lacosamide in painful diabetic neuropathy: a two-year open-label extension trial. Eur J Pain. 2009 May;13(5):458-63. doi: 10.1016/j.ejpain.2008.05.016. Epub 2008 Jul 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lacosamide	Other / unclassified	100 mg	Oral
Subject	Lacosamide	Other / unclassified	200 mg	Oral
Subject	Lacosamide	Other / unclassified	300 mg	Oral
Subject	Lacosamide	Other / unclassified	400 mg	Oral
Subject	Lacosamide	Other / unclassified	500 mg	Oral
Subject	Lacosamide	Other / unclassified	600 mg	Oral

A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy

Summary

Timeline

Publications

Drugs

Indications