EpilepsyPhase 2NCT00044278
Pediatric Epilepsy Study in Subjects 1-24 Months
A Phase 2 study testing lamotrigine in people with Epilepsy, run by GlaxoSmithKline at 70 sites in 15 countries.
Trial 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). 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
- 197 participants
- Where
- 70 sitesin 15 countries
- Study dates
- Sep 2000to Jun 2006
- 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
- 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.
Who cannot join
- 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 locations and contacts
70 sites in 15 countries.
70 sites in 15 countries
United States41 sites
GSK Investigational Site
Akron, Ohio, 44308-1062
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Buffalo, New York, 14222
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
Columbia, Missouri, 65211
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
Jonesboro, Arkansas, 72401
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
Mineola, New York, 11501
GSK Investigational Site
Mobile, Alabama, 36693
GSK Investigational Site
Morristown, Tennessee, 37813
GSK Investigational Site
Nashville, Tennessee, 37212
GSK Investigational Site
Norfolk, Virginia, 23507
GSK Investigational Site
Orlando, Florida, 32835
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213-2583
GSK Investigational Site
Portland, Oregon, 97201-2884
GSK Investigational Site
Portland, Oregon, 97201-2984
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Richmond, Virginia, 23298
GSK Investigational Site
Saint Paul, Minnesota, 55102-2383
GSK Investigational Site
Salt Lake City, Utah, 84113
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, 33609
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
Hungary5 sites
GSK Investigational Site
Budapest, 1094
GSK Investigational Site
Debrecen, 4012
GSK Investigational Site
Miskolc, 3526
GSK Investigational Site
Pécs, 7623
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
Argentina2 sites
GSK Investigational Site
Buenos Aires, 1425
GSK Investigational Site
Capital Federal, Buenos Aires, 1181
Slovakia2 sites
GSK Investigational Site
Bratislava, 833 40
GSK Investigational Site
Prešov, 080 01
Australia1 site
GSK Investigational Site
Parkville, Melbourne, Victoria, 3050
About this study
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)
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
- Epilepsy
- Being tested
- lamotrigine
- Keywords
- epilepsy, pediatric, partial seizures
- 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.
Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation
Measured: 43 Months
Change from baseline in vital signs -heart rate (HR)
Measured: Up to 43 Months
Change from baseline in vital signs - weight (WT)
Measured: Up to 43 months
Change from baseline in vital signs - height (HT)
Measured: Up to 43 months
Change from baseline in vital signs - head circumference (HC)
Measured: Up to 43 months
Change from baseline in clinical chemistry parameters including Albumin and Total protein
Measured: Up to month 43
Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST)
Measured: Up to 43 moths
Change from baseline in clinical chemistry parameters including total bilirubin and creatinine
Measured: Up to 43 months
Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea
Measured: Up to 43 months
Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)
Measured: Up to 43 moths
Change from baseline in Hemoglobin (Hb)
Measured: Up to 43 months
Change from baseline in Mean corpuscular hemoglobin (MCH)
Measured: Up to 43 months
Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)
Measured: Up to 43 months
Change from baseline in mean corpuscular volume (MCv)
Measured: Up to 43 months
Change from baseline in red blood cells (RBC)
Measured: Up to 43 months
Number of participants with treatment emergent neurological abnormalities
Measured: Up to 43 months
Number of participants with treatment emergent clinically significant ECG abnormalities
Measured: Up to 43 months
Number of participants with potentially clinically significant change in hematology parameters
Measured: Up to 43 months
Number of participants with potentially clinically significant change in clinical chemistry parameters
Measured: Up to 43 months
Number of participants with potentially clinically significant change in vital signs
Measured: Up to 43 months
Secondary outcomes (3)
Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase
Measured: Up to 48 Weeks
Investigator's assessment of the participant's overall clinical status
Measured: Up to 43 months
Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2002 (estimated)
- Study startSep 2000
- Primary completionJun 2006
- Study completionJun 2006
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 197 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
- NCT00044278
- Sponsor's protocol ID
- LAM20007
- Status last verified
- Jan 2017
- First submitted
- 23 Aug 2002
- Last updated
- 18 Jan 2017
- 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 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00044278
- Acronym / sponsor ID
- LAM20007
- Conditions
- Epilepsy
- Keywords
- epilepsy, pediatric, partial seizures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 26 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation
Time frame: 43 Months
Change from baseline in vital signs -heart rate (HR)
Time frame: Up to 43 Months
Change from baseline in vital signs - weight (WT)
Time frame: Up to 43 months
Change from baseline in vital signs - height (HT)
Time frame: Up to 43 months
Change from baseline in vital signs - head circumference (HC)
Time frame: Up to 43 months
Change from baseline in clinical chemistry parameters including Albumin and Total protein
Time frame: Up to month 43
Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST)
Time frame: Up to 43 moths
Change from baseline in clinical chemistry parameters including total bilirubin and creatinine
Time frame: Up to 43 months
Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea
Time frame: Up to 43 months
Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)
Time frame: Up to 43 moths
Change from baseline in Hemoglobin (Hb)
Time frame: Up to 43 months
Change from baseline in Mean corpuscular hemoglobin (MCH)
Time frame: Up to 43 months
Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)
Time frame: Up to 43 months
Change from baseline in mean corpuscular volume (MCv)
Time frame: Up to 43 months
Change from baseline in red blood cells (RBC)
Time frame: Up to 43 months
Number of participants with treatment emergent neurological abnormalities
Time frame: Up to 43 months
Number of participants with treatment emergent clinically significant ECG abnormalities
Time frame: Up to 43 months
Number of participants with potentially clinically significant change in hematology parameters
Time frame: Up to 43 months
Number of participants with potentially clinically significant change in clinical chemistry parameters
Time frame: Up to 43 months
Number of participants with potentially clinically significant change in vital signs
Time frame: Up to 43 months
3 secondary outcomes
Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase
Time frame: Up to 48 Weeks
Investigator's assessment of the participant's overall clinical status
Time frame: Up to 43 months
Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants
Time frame: Week 6
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 18 Jan 2017.
- 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
70 sites in 15 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 70 sites in 15 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 4 inclusion and 5 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, Italy, Hungary, Netherlands, Portugal and 10 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?
Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation (time frame: 43 Months). The study lists 20 primary outcomes in all. 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 18 Jan 2017.