A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given as iv infusions compared with oral administration of the same dose strengths in subjects who were receiving oral SPM 927 for partial seizures with or without secondary generalization.

Trial procedures will include medical history update, physical/ neurological exams, ECGs, blood /urine sample collections and seizure diary completion.

Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM 927.

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

Details

• Lead Sponsor: UCB Pharma
• Treatments: Lacosamide

Criteria

Inclusion Criteria:

• Subject with partial seizures with or without secondary generalization

Exclusion Criteria:

• Subject had previously received iv SPM 927

• Subject met the withdrawal criteria for the open-label extension trial with SPM 927 or was experiencing an ongoing serious adverse event.