A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927
A Multicenter, Double-blind, Double-dummy, Randomized Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures With or Without Secondary Generalization
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given as iv infusions compared with oral administration of the same dose strengths in subjects who were receiving oral SPM 927 for partial seizures with or without secondary generalization. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2004
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2004
CompletedFirst Submitted
Initial submission to the registry
December 1, 2008
CompletedFirst Posted
Study publicly available on registry
December 2, 2008
CompletedApril 19, 2024
April 1, 2024
6 months
December 1, 2008
April 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination
2 Days
Secondary Outcomes (1)
Seizure counts
2 days
Study Arms (4)
1
EXPERIMENTAL2
PLACEBO COMPARATOR3
EXPERIMENTAL4
PLACEBO COMPARATORInterventions
60-minute infusion iv SPM 927 and oral placebo tablet
60-minute infusion placebo and oral SPM 927 tablet
Eligibility Criteria
You may qualify if:
- Subject with partial seizures with or without secondary generalization
You may not qualify if:
- Subject had previously received iv SPM 927
- Subject met the withdrawal criteria for the open-label extension trial with SPM 927 or was experiencing an ongoing serious adverse event.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Related Publications (1)
Biton V, Rosenfeld WE, Whitesides J, Fountain NB, Vaiciene N, Rudd GD. Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures. Epilepsia. 2008 Mar;49(3):418-24. doi: 10.1111/j.1528-1167.2007.01317.x. Epub 2007 Sep 19.
PMID: 17888078RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2008
First Posted
December 2, 2008
Study Start
March 4, 2004
Primary Completion
August 17, 2004
Study Completion
November 30, 2004
Last Updated
April 19, 2024
Record last verified: 2024-04