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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00151879
First received: September 7, 2005
Last updated: September 9, 2013
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Epilepsies, Partial
Drug: SPM 927
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Seizure counts, trough and measured maximum concentration for lacosamide as well as the O-desmethyl-metabolite.

Enrollment: 160
Study Start Date: February 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151879

Locations
United States, North Carolina
Schwarz
RTP, North Carolina, United States
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00151879     History of Changes
Other Study ID Numbers: SP757
Study First Received: September 7, 2005
Last Updated: September 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
partial seizures with or without secondary generalization

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014