Back to resultsSafety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures
Primary Purpose
Epilepsies, Partial
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SPM 927
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsies, Partial focused on measuring partial seizures with or without secondary generalization
Eligibility 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.
Sites / Locations
- Schwarz
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00151879
Brief Title
Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures
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 Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsies, Partial
Keywords
partial seizures with or without secondary generalization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SPM 927
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Seizure counts, trough and measured maximum concentration for lacosamide as well as the O-desmethyl-metabolite.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Schwarz
City
RTP
State/Province
North Carolina
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20041945
Citation
Krauss G, Ben-Menachem E, Mameniskiene R, Vaiciene-Magistris N, Brock M, Whitesides JG, Johnson ME; SP757 Study Group. Intravenous lacosamide as short-term replacement for oral lacosamide in partial-onset seizures. Epilepsia. 2010 Jun;51(6):951-7. doi: 10.1111/j.1528-1167.2009.02463.x. Epub 2009 Dec 22.
Results Reference
result
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Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures
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