A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures.
SP0966 is an exploratory study to investigate safety and efficacy of Lacosamide (LCM) in children with epilepsy syndromes associated with generalized seizures. LCM will be added to current antiepileptic treatment.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A MULTI-CENTER, OPEN-LABEL, EXPLORATORY STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS ≥1 MONTH TO <18 YEARS WITH EPILEPSY SYNDROMES ASSOCIATED WITH GENERALIZED SEIZURES.|
- Changes in count of generalized spike-wave discharges on 24-hour ambulatory electroencephalogram (EEG) from Visit 2 to Visit 6 [ Time Frame: Visit 2; Visit 6 ] [ Designated as safety issue: No ]
- Change in days with any generalized seizures (absence, myoclonic, clonic, tonic, tonic-clonic, atonic, partial evolving to secondarily generalized) per 28 days from the Baseline Period to the Maintenance Period (approximately 24 weeks) [ Time Frame: Baseline Period to the Maintenance Period (approximately 24 weeks) ] [ Designated as safety issue: No ]
- Changes in count of 3Hz spike-wave discharges (during waking hours) on 24-hour ambulatory EEG from Visit 2 to Visit 6 [ Time Frame: Visit 2; Visit 6 ] [ Designated as safety issue: No ]
- Number of subject withdrawals due to Adverse Events from baseline to end of study (approximately 32 weeks) [ Time Frame: From Baseline to End of Study (approximately 32 weeks) ] [ Designated as safety issue: No ]
- Number of subjects experiencing at least 1 Treatment-emergent Adverse event from baseline to end of study (approximately 32 weeks) [ Time Frame: From Baseline to End of Study (approximately 32 weeks) ] [ Designated as safety issue: No ]
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Oral intake twice daily of tablet (100 mg or 50 mg) or syrup formulation (10 mg/ml).
Total daily dose will be titrated over a period of 6 weeks with starting dose of 100 mg/day or 2 mg/kg/day up to doses not exceeding 600 mg/day or 12 mg/kg/day tablet or syrup, respectively. Followed by a 12 week maintenance period with stable dosing of at least 200 mg/day or 4 mg/kg/day tablet or syrup, respectively.
Other Name: Vimpat
SP0966 is a Phase 2, multicenter, open-label exploratory study designed to assess the safety and preliminary efficacy of oral lacosamide as adjunctive therapy for epilepsy syndromes associated with generalized seizures in pediatric subjects ≥1 month to <18 years of age.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01969851
|Contact: UCB Clinical Trial Call Center||1 877 822 9493|
|United States, California|
|Los Angeles, California, United States|
|United States, Florida|
|Orlando, Florida, United States|
|Wellington, Florida, United States|
|United States, Georgia|
|Augusta, Georgia, United States|
|United States, Kentucky|
|Louisville, Kentucky, United States|
|United States, Nevada|
|Henderson, Nevada, United States|
|United States, New Jersey|
|Hackensack, New Jersey, United States|
|New Brunswick, New Jersey, United States|
|United States, Ohio|
|Akron, Ohio, United States|
|Study Director:||UCB Clinical Trial Call Center||1 877 822 9493|