Back to resultsSPM 927 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SPM 927
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy with partial seizures
Eligibility Criteria
Inclusion Criteria: Epilepsy with partial seizures Exclusion Criteria: Subject received SPM 927 in a previous trial
Sites / Locations
Outcomes
Primary Outcome Measures
Efficacy 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.
Secondary Outcome Measures
Safety of lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, and clinical laboratory data.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00136019
Brief Title
SPM 927 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization
Official Title
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
Brief Summary
Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with partial seizures and are taking up to 3 medications for this medical condition will take part in a research study at approximately 85 different locations in the United States.
The purpose of the study is to evaluate the effectiveness, safety and tolerability of consistent dosages of a study drug (lacosamide [SPM 927]) taken orally twice a day for about five months.
Each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide up to the target dose of 400mg/day or 600mg/day. The target dose or placebo will be maintained for 12 weeks.
The study clinic visits will include a medical history and physical exam, electrocardiogram (ECG), blood and urine sample collection, and completion of a seizure diary.
Patients who complete the study may enroll in an extension trial and receive active study drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy with partial seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SPM 927
Primary Outcome Measure Information:
Title
Efficacy 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.
Secondary Outcome Measure Information:
Title
Safety of lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, and clinical laboratory data.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Epilepsy with partial seizures
Exclusion Criteria:
Subject received SPM 927 in a previous trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20132285
Citation
Chung S, Sperling MR, Biton V, Krauss G, Hebert D, Rudd GD, Doty P; SP754 Study Group. Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia. 2010 Jun;51(6):958-67. doi: 10.1111/j.1528-1167.2009.02496.x. Epub 2010 Jan 27.
Results Reference
result
PubMed Identifier
21090839
Citation
Sake JK, Hebert D, Isojarvi J, Doty P, De Backer M, Davies K, Eggert-Formella A, Zackheim J. A pooled analysis of lacosamide clinical trial data grouped by mechanism of action of concomitant antiepileptic drugs. CNS Drugs. 2010 Dec;24(12):1055-68. doi: 10.2165/11587550-000000000-00000.
Results Reference
result
PubMed Identifier
22341962
Citation
Borghs S, de la Loge C, Cramer JA. Defining minimally important change in QOLIE-31 scores: estimates from three placebo-controlled lacosamide trials in patients with partial-onset seizures. Epilepsy Behav. 2012 Mar;23(3):230-4. doi: 10.1016/j.yebeh.2011.12.023. Epub 2012 Feb 15.
Results Reference
result
PubMed Identifier
26414341
Citation
Biton V, Gil-Nagel A, Isojarvi J, Doty P, Hebert D, Fountain NB. Safety and tolerability of lacosamide as adjunctive therapy for adults with partial-onset seizures: Analysis of data pooled from three randomized, double-blind, placebo-controlled clinical trials. Epilepsy Behav. 2015 Nov;52(Pt A):119-27. doi: 10.1016/j.yebeh.2015.09.006. Epub 2015 Sep 27.
Results Reference
derived
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SPM 927 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization
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