Last updated: 11/04/2018 08:38:37
Pediatric Epilepsy Trial in Subjects 1-24 Months
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 months)
Trial description: This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase.
Timeframe: 36 Months
Secondary outcomes:
Time to escape patterns in Double-Blind phase. Reduction in partial seizure frequency at end of Open-Label Phase. Investigators' global evaluation of subjects' status at end of Open-Label and Double-Blind Phases; Standard pharmacokinetics; Adverse Events
Timeframe: 36 Months
Interventions:
Drug: lamotrigine
Enrollment:
177
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
May 2000 to November 2003
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
1 - 24 months
Accepts healthy volunteers
No
- Have a confident diagnosis of epilepsy
- Must be experiencing 4 or more reliably detectable partial seizures per month while receiving at least 1 anti-epileptic drug (AED)
- Have a diagnosis of severe, progressive myoclonus.
- Have seizures not related to epilepsy.
Inclusion and exclusion criteria
Inclusion criteria:
- Have a confident diagnosis of epilepsy
- Must be experiencing 4 or more reliably detectable partial seizures per month while receiving at least 1 anti-epileptic drug (AED)
- Must weigh at least 7 lbs if currently receiving enzyme inducing antiepileptic drugs (EIADs) OR weigh at least 15 lbs if currently receiving non-enzyme inducing antiepileptic drugs (non-EIADs)
- Have no underlying chronic metabolism problems
- Have normal lab results
- Have a normal electrocardiogram (ECG)
Exclusion criteria:
- Have a diagnosis of severe, progressive myoclonus.
- Have seizures not related to epilepsy.
- Have previously demonstrated sensitivity or allergic reaction to the study drug or its related compounds.
- Have progressive or unstable condition of the nervous system.
- Used experimental medication within 30 of enrollment into the study.
- Have any significant, chronic heart, kidney, liver or stomach/intestinal (GI) condition.
- Current use of the medication felbamate.
- Current use of adrenocorticotrophic hormone (ACTH).
- Following a ketogenic diet.
- Receiving vagal nerve stimulation (VNS).
Trial location(s)
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23510
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stanford, California, United States, 94305-5235
Status
Study Complete
Location
GSK Investigational Site
St. Paul, Minnesota, United States, 55102-2383
Status
Study Complete
Location
GSK Investigational Site
Parkville, Melbourne, Victoria, Australia, 3050
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0284
Status
Study Complete
Location
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213-2583
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, California, United States, 90027
Status
Study Complete
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44106
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West Heidleberg, Melbourne, Victoria, Australia
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cherry Hill, New Jersey, United States, 8034
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Banska Bystrica, Slovakia, 975 17
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Augusta, Georgia, United States, 30912
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32207
Status
Study Complete
Location
GSK Investigational Site
Las Palmas De Gran Canaria, Spain, 35016
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90095
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72202
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32835
Status
Study Complete
Location
GSK Investigational Site
Tampa, Florida, United States, 33607-6350
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Houston, Texas, United States, 77030
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Akron, Ohio, United States, 44308-1062
Status
Study Complete
Location
GSK Investigational Site
Miami, Florida, United States, 33155-3009
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23298
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Denver, Colorado, United States, 80218
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64108
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37212
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20010
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2003-25-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website