Last updated: 11/04/2018 08:39:15
Pediatric Epilepsy Study in Subjects 1-24 Months
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation
Timeframe: Up to 50 weeks
Change from baseline in vital signs -heart rate (HR)
Timeframe: Baseline and up to 24 months
Change from baseline in vital signs - body weight
Timeframe: Baseline and up to 24 months
Change from baseline in vital signs - height
Timeframe: Baseline and up to 24 months
Change from baseline in vital signs – head circumference
Timeframe: Baseline and up to 24 months
Change from baseline in clinical chemistry parameters including Albumin and Total protein
Timeframe: Baseline and up to 24 months
Change from baseline in clinical chemistry parameters including alkaline phosphatase (ALP), alanine transaminase (ALT), and aspartate aminotransferase (AST)
Timeframe: Baseline and up to 24 months
Change from baseline in clinical chemistry parameters including total bilirubin and creatinine
Timeframe: Baseline and up to 24 months
Change from baseline in clinical chemistry parameters including glucose, potassium, sodium and urea
Timeframe: Baseline and up to 24 months
Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)
Timeframe: Baseline and up to 24 months
Change from baseline in Hemoglobin
Timeframe: Baseline and up to 24 months
Change from baseline in Mean corpuscular hemoglobin (MCH)
Timeframe: Baseline and up to 24 months
Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)
Timeframe: Baseline and up to 24 months
Change from baseline in mean corpuscular volume (MCV)
Timeframe: Baseline and up to 24 months
Change from baseline in red blood cells (RBC)
Timeframe: Baseline and up to 24 months
Number of participants with treatment emergent neurological abnormalities
Timeframe: Baseline and up to 24 months
Number of participants with treatment emergent clinically significant electrocardiogram (ECG) abnormalities
Timeframe: Baseline and up to 24 months
Number of participants with potential clinically significant hematology abnormalities
Timeframe: Baseline and up to 24 months
Number of participants with potential clinically significant clinical chemistry abnormalities
Timeframe: Baseline and up to 24 months
Number of participants with potential clinically significant vital signs abnormalities
Timeframe: Baseline and up to 24 months
Secondary outcomes:
Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase
Timeframe: Up to 48 Weeks
Investigator’s overall assessment of the participants' clinical status at the last visit while on study drug
Timeframe: Termination visit (last visit while on study drug)
Mean Maximal plasma concentration (Cmax) of LTG in serum of Lamicital -naïve participants
Timeframe: pre-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose.
Mean Cmax of LTG in saliva of Lamicital -naïve participants
Timeframe: Pre-dose and at 1, 2, 3, 4, 6 and 8 hours after dose.
Median time to maximal serum or plasma concentration (tmax) of LTG in serum of LTG-naïve participants
Timeframe: Pe-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose.
Median tmax of LTG in saliva of LTG-naïve participants
Timeframe: Pre-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose
Mean area under the concentration-time curve over the dosing interval 0 to 8 hours (AUC0-8) of lamotrigine in serum
Timeframe: Pre-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose
Mean AUC0-8 of LTG in saliva of LTG-naïve participants
Timeframe: Pre-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose
Mean steady state apparent clearance (CLss/F) of lamotrigine in serum
Timeframe: Pre-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose
Mean steady state apparent clearance per weight (CLss/F/BW) of lamotrigine in serum
Timeframe: Pre-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose
Interventions:
Enrollment:
204
Primary completion date:
2006-27-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
September 2000 to June 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
1 - 24 months
Accepts healthy volunteers
No
- Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows:
- A confident diagnosis of epilepsy.
- Has seizures not related to epilepsy.
- Has a surgically implanted and functioning vagal nerve stimulator.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64108
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213-2583
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, California, United States, 90095
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Augusta, Georgia, United States, 30912
Status
Study Complete
Location
GSK Investigational Site
Houston, Texas, United States, 77030
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20010
Status
Study Complete
Location
GSK Investigational Site
Akron, Ohio, United States, 44308-1062
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Morristown, Tennessee, United States, 37813
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Buffalo, New York, United States, 14222
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84113
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mineola, New York, United States, 11501
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0284
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
Parkville, Melbourne, Victoria, Australia, 3050
Status
Terminated/Withdrawn
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
St. Paul, Minnesota, United States, 55102-2383
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orlando, Florida, United States, 32835
Status
Study Complete
Location
GSK Investigational Site
Stanford, California, United States, 94305-5235
Status
Study Complete
Location
GSK Investigational Site
Columbia, Missouri, United States, 65211
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32207
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97201-2984
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37212
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90027
Status
Study Complete
Location
GSK Investigational Site
Cherry Hill, New Jersey, United States, 8034
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Denver, Colorado, United States, 80218
Status
Study Complete
Location
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, 1181
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72202
Status
Study Complete
Location
GSK Investigational Site
SanJuan, Puerto Rico, Puerto Rico, 00936
Status
Study Complete
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
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
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2006-27-06
Actual study completion date
2006-27-06
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
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