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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Lacosamide

Criteria

Inclusion Criteria:

• Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor.

Exclusion Criteria:

• Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected (QTc) interval >=500 milliseconds (ms), and/or a QTc interval increase of >=60ms from the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP768.

• Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >=3 times the upper limit of the normal range (ULN) with total bilirubin >=2 times ULN or transaminases (AST and/or ALT) >=5 times ULN.

• Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial.