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Trial record 1 of 1 for:    NCT00151879
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Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00151879
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : September 22, 2014
Information provided by:
UCB Pharma

Brief Summary:

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 or disease Intervention/treatment Phase
Epilepsies, Partial Drug: SPM 927 Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : February 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00151879

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United States, North Carolina
RTP, North Carolina, United States
Sponsors and Collaborators
UCB Pharma
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Study Director: UCB Clinical Trial Call Center UCB Pharma
Publications of Results:
Layout table for additonal information Identifier: NCT00151879    
Other Study ID Numbers: SP0757
2004-002322-22 ( EudraCT Number )
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: July 2010
Keywords provided by UCB Pharma:
partial seizures with or without secondary generalization
Additional relevant MeSH terms:
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Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations