Pediatric Epilepsy Study in Subjects 1-24 Months
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: lamotrigine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The long-term safety of LAMICTAL will be assessed by adverse events, ECGs, vital signs,and laboratory tests.
Secondary outcome: Effectiveness will be assessed by percent change from baseline in seizure frequency over the course of treatment. Investigators global evaluation of subjects status; standard pharmacokinetics.
Eligibility
Minimum age: 1 Month.
Maximum age: 24 Months.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for
LAMICTAL naive subjects as follows:
- A confident diagnosis of epilepsy.
- 4 or more partial seizures per month.
- current treatment with 1 or 2 anti-epileptic drugs.
Exclusion criteria:
- Has seizures not related to epilepsy.
- Has a surgically implanted and functioning vagal nerve stimulator.
- Has previously been treated with lamotrigine.
- Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the
ketogenic diet.
- Use of experimental medication within 30 days of enrollment.
Locations and Contacts
GSK Investigational Site, Beirut 11072020, Lebanon
GSK Investigational Site, Rotterdam 3015 GD, Netherlands
GSK Investigational Site, Coimbra 3000-075, Portugal
GSK Investigational Site, Lisboa 1150, Portugal
GSK Investigational Site, Porto 4099-001, Portugal
GSK Investigational Site, Ankara, Turkey
Additional Information
Starting date: September 2000
Last updated: April 14, 2015
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