Pediatric Epilepsy Study in Subjects 1-24 Months
NCT00044278 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 197
Last updated 2017-01-18
Summary
This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.
Conditions
Interventions
- DRUG
-
lamotrigine
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Month
- Max Age
- 24 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-09-30
- Primary Completion
- 2006-06-30
- Completion
- 2006-06-30
Countries
- United States
- Argentina
- Australia
- Estonia
- France
- Hungary
- Italy
- Latvia
- Lebanon
- Lithuania
- Netherlands
- Portugal
- Puerto Rico
- Slovakia
- Turkey (Türkiye)
Study Locations
More Related Trials
-
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.
NCT01969851 ·Status: COMPLETED ·Phase: PHASE2
-
A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
NCT00938431 ·Status: COMPLETED ·Phase: PHASE2
-
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures
NCT00104416 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
NCT00113165 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of the Efficacy and Safety of Lacosamide in Pediatric Patients With Epilepsy
NCT04144218 ·Status: UNKNOWN ·Phase: PHASE4
-
Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
NCT01921205 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
NCT02408549 ·Status: COMPLETED ·Phase: PHASE3
-
Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy
NCT00505934 ·Status: COMPLETED ·Phase: PHASE2
-
Pediatric Epilepsy Study
NCT00050947 ·Status: COMPLETED ·Phase: PHASE3
-
Drug Use Investigation for LAMICTAL
NCT01376180 ·Status: COMPLETED
-
A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
NCT02408523 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors
NCT02276053 ·Status: COMPLETED
-
Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
NCT00448916 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment
NCT04627285 ·Status: COMPLETED ·Phase: PHASE3
-
Pediatric Epilepsy Study
NCT00050934 ·Status: COMPLETED ·Phase: PHASE3
-
An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy
NCT00938912 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Study of Lamotrigine to Treat Newly Diagnosed Typical Absence Seizure in Children and Adolescents
NCT01431976 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
NCT04519645 ·Status: TERMINATED ·Phase: PHASE2
-
The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children
NCT05697614 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
NCT04015141 ·Status: RECRUITING ·Phase: PHASE2
-
Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures
NCT00113815 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
NCT01527006 ·Status: COMPLETED ·Phase: PHASE2
-
Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy
NCT00535392 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures
NCT00437281 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
NCT00522275 ·Status: COMPLETED ·Phase: PHASE3