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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iv SPM 927 and oral placebo tablet

Drug

60-minute infusion iv SPM 927 and oral placebo tablet

Other names: Lacosamide, Vimpat

oral SPM 927 tablet and iv placebo

Drug

60-minute infusion placebo and oral SPM 927 tablet

Other names: Lacosamide, Vimpat

Primary outcomes

Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination

Time frame: 2 Days

Secondary outcomes

Seizure counts

Time frame: 2 days

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2004
First posted: Dec 2, 2008
Registry last updated: Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed