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.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01969851|
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : September 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Lacosamide||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||February 13, 2014|
|Actual Primary Completion Date :||April 10, 2018|
|Actual Study Completion Date :||April 10, 2018|
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
- 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 ]
- 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) ]
- 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 ]
- 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) ]
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969851
|United States, California|
|Los Angeles, California, United States|
|United States, Florida|
|Orlando, Florida, 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|
|Lyon Cedex, France|
|Study Director:||UCB Cares||+1 844 599 2273|