Back to resultsA Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
iv SPM 927 and oral placebo tablet
oral SPM 927 tablet and iv placebo
iv SPM 927 and oral placebo tablet
oral SPM 927 tablet and iv placebo
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Subject with partial seizures with or without secondary generalization
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination
Secondary Outcome Measures
Seizure counts
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00800215
Brief Title
A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 4, 2004 (Actual)
Primary Completion Date
August 17, 2004 (Actual)
Study Completion Date
November 30, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
iv SPM 927 and oral placebo tablet
Other Intervention Name(s)
Lacosamide, Vimpat
Intervention Description
60-minute infusion iv SPM 927 and oral placebo tablet
Intervention Type
Drug
Intervention Name(s)
oral SPM 927 tablet and iv placebo
Other Intervention Name(s)
Lacosamide, Vimpat
Intervention Description
60-minute infusion placebo and oral SPM 927 tablet
Intervention Type
Drug
Intervention Name(s)
iv SPM 927 and oral placebo tablet
Other Intervention Name(s)
Lacosamide, Vimpat
Intervention Description
30-minute infusion iv SPM 927 and oral placebo tablet
Intervention Type
Drug
Intervention Name(s)
oral SPM 927 tablet and iv placebo
Other Intervention Name(s)
Lacosamide, Vimpat
Intervention Description
30-minute infusion placebo and oral SPM 927 tablet
Primary Outcome Measure Information:
Title
Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination
Time Frame
2 Days
Secondary Outcome Measure Information:
Title
Seizure counts
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject with partial seizures with or without secondary generalization
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17888078
Citation
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.
Results Reference
result
Links:
URL
https://www.ucb.com/website/_up/ucb_com_patients/documents/SP616_CSS_20081118.pdf
Description
Clinical Study Summary on UCB.com
Learn more about this trial
A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927
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