A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927
April 18, 2024 updated by: UCB Pharma
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
60-minute infusion iv SPM 927 and oral placebo tablet
Other Names:
30-minute infusion iv SPM 927 and oral placebo tablet
Other Names:
|
|
Placebo Comparator: 2
|
60-minute infusion placebo and oral SPM 927 tablet
Other Names:
30-minute infusion placebo and oral SPM 927 tablet
Other Names:
|
|
Experimental: 3
|
60-minute infusion iv SPM 927 and oral placebo tablet
Other Names:
30-minute infusion iv SPM 927 and oral placebo tablet
Other Names:
|
|
Placebo Comparator: 4
|
60-minute infusion placebo and oral SPM 927 tablet
Other Names:
30-minute infusion placebo and oral SPM 927 tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination
Time Frame: 2 Days
|
2 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Seizure counts
Time Frame: 2 days
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2004
Primary Completion (Actual)
August 17, 2004
Study Completion (Actual)
November 30, 2004
Study Registration Dates
First Submitted
December 1, 2008
First Submitted That Met QC Criteria
December 1, 2008
First Posted (Estimated)
December 2, 2008
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP616
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.