NCT00800215

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

A Multicenter, Double-blind, Double-dummy, Randomized Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures With or Without Secondary Generalization

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	iv SPM 927 and oral placebo tablet	60-minute infusion iv SPM 927 and oral placebo tablet
DRUG	oral SPM 927 tablet and iv placebo	60-minute infusion placebo and oral SPM 927 tablet
DRUG	iv SPM 927 and oral placebo tablet	30-minute infusion iv SPM 927 and oral placebo tablet
DRUG	oral SPM 927 tablet and iv placebo	30-minute infusion placebo and oral SPM 927 tablet

Timeline

• Start date: 2004-03-04
• Primary completion: 2004-08-17
• Completion: 2004-11-30
• First posted: 2008-12-02
• Last updated: 2024-04-19