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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 27, 2007 | ||||
| Last Updated Date | November 11, 2009 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety of long-term exposure to lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, and clinical laboratory data. [ Time Frame: At periodic clinic visits throughout the trial ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Safety of long-term exposure to lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, and clinical laboratory data. [ Time Frame: At periodic clinic visits throughout the trial ] | ||||
| Change History | Complete list of historical versions of study NCT00522275 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Efficacy and maintenance of efficacy with long-term exposure to lacosamide is evaluated based on reduction in seizure frequency, 50 percent reduction in seizures, number and percentage of seizure-free days, and achievement of seizure-free status. [ Time Frame: At periodic clinic visits throughout the trial ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Efficacy and maintenance of efficacy with long-term exposure to lacosamide is evaluated based on reduction in seizure frequency, 50 percent reduction in seizures, number and percentage of seizure-free days, and achievement of seizure-free status. [ Time Frame: At periodic clinic visits throughout the trial ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures | ||||
| Official Title ICMJE | An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures | ||||
| Brief Summary | The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Partial Epilepsies | ||||
| Intervention ICMJE | Drug: lacosamide
50mg or 100 mg tablets, up to 800 mg/day given as BID dosing throughout the trial |
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| Study Arms / Comparison Groups | Lacosamide: Experimental
Up to 800mg/day lacosamide (flexible dosing)
Intervention: Drug: lacosamide |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 308 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00522275 | ||||
| Responsible Party | Study Director, UCB | ||||
| Study ID Numbers ICMJE | SP756 | ||||
| Study Sponsor ICMJE | UCB, Inc. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | UCB, Inc. | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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