Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures

Completed · Phase 2/Phase 3

Conditions studied: Epilepsies, Partial

In brief

Subjects enrolled in the SP615, SP756, or SP774 open-label extension (OLE) trials receiving oral SPM 927 for at least 8 weeks and a stable dose of up to 3 antiepileptic medications may participate in a research trial at approximately 30 locations. Trial objectives include investigating whether iv SPM 927 is safe and well tolerated when given twice daily for a short period of time and identifying the appropriate infusion rate(s). Subjects will receive SPM 927 as a 30-, 15- or 10- minute infusions twice daily for 2 - 5 days based on notification by the research doctor and subject choice. Subjects will remain on the same stable dose as received in the OLE trial. 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.

Key facts

Study ID

NCT00151879

Run by

UCB Pharma

People needed

160

Starts

2005-02-01

Expected to finish

2006-05-01

Last updated by the study team

2014-09-22

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Partial seizures with or without secondary generalization.

You may not qualify if…

• Subject has previously received iv lacosamide.
• Subject meets the withdrawal criteria for the open-label extension trial.

Where it is running

• Schwarz — RTP, North Carolina, United States

Full record on ClinicalTrials.gov

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