EpilepsyPhase 2NCT00043875
Pediatric Epilepsy Trial in Subjects 1-24 Months
A Phase 2 study testing lamotrigine in people with Epilepsy, run by GlaxoSmithKline at 65 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Epilepsy
- What is being tested?
- lamotrigine
- How many people
- 177 participants
- Where
- 65 sitesin 14 countries
- Study dates
- May 2000to Nov 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 10Show fewer
- Current use of the medication felbamate.
- Current use of adrenocorticotrophic hormone (ACTH).
- Following a ketogenic diet.
- Receiving vagal nerve stimulation (VNS).
Trial locations and contacts
65 sites in 14 countries.
65 sites in 14 countries
United States34 sites
GSK Investigational Site
Akron, Ohio, 44308-1062
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Chapel Hill, North Carolina, 27599
GSK Investigational Site
Charlottesville, Virginia, 22908
GSK Investigational Site
Cherry Hill, New Jersey, 8034
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Columbus, Ohio, 43205
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Denver, Colorado, 80218
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Jacksonville, Florida, 32207
GSK Investigational Site
Kansas City, Missouri, 64108
GSK Investigational Site
Lexington, Kentucky, 40536-0284
GSK Investigational Site
Little Rock, Arkansas, 72202
GSK Investigational Site
Los Angeles, California, 90027
GSK Investigational Site
Los Angeles, California, 90095
GSK Investigational Site
Miami, Florida, 33155-3009
GSK Investigational Site
Nashville, Tennessee, 37212
GSK Investigational Site
Norfolk, Virginia, 23510
GSK Investigational Site
Orlando, Florida, 32835
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213-2583
GSK Investigational Site
Portland, Oregon, 97227
GSK Investigational Site
Portland, Oregon, 97239
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Richmond, Virginia, 23298
GSK Investigational Site
Saint Paul, Minnesota, 55102-2383
GSK Investigational Site
Stanford, California, 94305-5235
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
Tallahassee, Florida, 32308
GSK Investigational Site
Tampa, Florida, 33607-6350
GSK Investigational Site
Tucson, Arizona, 85712
GSK Investigational Site
Washington D.C., District of Columbia, 20010
Italy6 sites
GSK Investigational Site
Bologna, Emilia-Romagna, 40138
GSK Investigational Site
Mantua, Lombardy, 46100
GSK Investigational Site
Messina, Sicily, 98125
GSK Investigational Site
Milan, Lombardy, 20133
GSK Investigational Site
Naples, Campania, 80131
GSK Investigational Site
Padova, Veneto, 35128
Australia4 sites
GSK Investigational Site
Parkville, Melbourne, Victoria, 3050
GSK Investigational Site
Perth, Western Australia
GSK Investigational Site
South Brisbane, Queensland, 4101
GSK Investigational Site
West Heidleberg, Melbourne, Victoria
Hungary4 sites
GSK Investigational Site
Budapest, 1094
GSK Investigational Site
Debrecen, 4012
GSK Investigational Site
Miskolc, 3526
GSK Investigational Site
Szeged, 6720
Netherlands3 sites
GSK Investigational Site
Groningen, 9713 GZ
GSK Investigational Site
Rotterdam, 3015 GD
GSK Investigational Site
Utrecht, 3584 EA
Portugal3 sites
GSK Investigational Site
Coimbra, 3000-075
GSK Investigational Site
Lisbon, 1150
GSK Investigational Site
Porto, 4099-001
Slovakia3 sites
GSK Investigational Site
Banská Bystrica, 975 17
GSK Investigational Site
Bratislava, 833 40
GSK Investigational Site
Prešov, 080 01
Estonia2 sites
GSK Investigational Site
Tallinn, 13419
GSK Investigational Site
Tartu, 51014
About this study
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)
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.
- Conditions
- Epilepsy
- Being tested
- lamotrigine
- Keywords
- partial seizures, pediatric, epilepsy
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lamotrigineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase.
Measured: 36 Months
Secondary outcomes (1)
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
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2002 (estimated)
- Study startMay 2000
- Primary completionNov 2003
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043875
- Sponsor's protocol ID
- LAM20006
- Status last verified
- Sep 2016
- First submitted
- 14 Aug 2002
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00043875
- Acronym / sponsor ID
- LAM20006
- Conditions
- Epilepsy
- Keywords
- partial seizures, pediatric, epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2003 (actual)
- First posted
- 15 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lamotrigine | Drug | – |
Primary outcome
The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase.
Time frame: 36 Months
1 secondary outcome
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
Time frame: 36 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
65 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lamotrigine in people with Epilepsy, run by GlaxoSmithKline at 65 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Italy, Australia, Hungary, Netherlands and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase. (time frame: 36 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016; AzTrials last refreshed its copy on 6 Nov 2026.