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Completed

NCT Number: NCT00151879

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

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.

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Key information

Conditions

Epilepsies, Partial Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Schwarz

RTP, North Carolina, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Partial seizures with or without secondary generalization.

Exclusion criteria

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

Treatment and study plan

SPM 927

Drug

Primary outcomes

  1. Evaluate the safety and tolerability of lacosamide when given as iv infusions in subjects who are receiving oral lacosamide in addition to up to 3 concomitant AEDs for partial seizures. The primary variables are adverse events

Secondary outcomes

  1. Seizure counts, trough and measured maximum concentration for lacosamide as well as the O-desmethyl-metabolite.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Multicenter, Open-label Trial to Investigate the Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures With or Without Secondary Generalization.

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 9, 2005
Registry last updated
Sep 22, 2014

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.

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