Epilepsies, Partial Clinical Trial
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.
| Verified date | July 2010 |
| Source | UCB Pharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | May 2006 |
| Est. primary completion date | May 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Schwarz | RTP | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| UCB Pharma |
United States,
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Seizure counts, trough and measured maximum concentration for lacosamide as well as the O-desmethyl-metabolite. |
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