Seizure, AbsencePhase 1NCT00144872
LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures
A Phase 1 study testing Lamotrigine in people with Seizure, Absence, run by GlaxoSmithKline at 23 sites in United States.
Trial summary
This is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the treatment of newly-diagnosed typical absence seizures. Subjects will be children and adolescents < 13 years of age. It will be conducted at multiple sites in the US. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Seizure, Absence
- What is being tested?
- Lamotrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 23 sitesUnited States
- Study dates
- 1 Nov 2004to 22 Apr 2006
- Phase
- Phase 1
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newly-diagnosed with absence epilepsy and never been treated with Anti-epileptic drugs (AEDs).
- Diagnosis demonstrated on one of two 5-minute hyperventilation tests.
- Investigator must judge that the subject and parent/guardian are likely to comply with all study procedures.
- Parent/guardian must given written informed consent. Subjects who are intellectually able to understand the concepts and procedures of the protocol must give assent by also signing the consent or by signing a separate assent form.
- Results of all screen assessments are judged to be clinically acceptable to the investigator and do not indicate any reasons why entry into the study would be contraindicated.
Who cannot join
- Seizures are the result of a currently active, known, and identifiable intracerebral lesion.
- Has partial or generalized tonic-clonic seizures.
- Has a progressive neurological disorder defined as being unstable for at least 12 weeks prior to the Screen Phase.
- Has a psychiatric disorder requiring medication, or has had a past psychiatric condition that was both judged to be severe and required hospitalization.
- Has any clinically significant chronic cardiac, renal, or hepatic medical condition.
- Has a condition that affects the absorption, distribution, metabolism, or excretion of drugs.
Show all 11Show fewer
- Is currently taking any psychoactive drugs to treat hyperactivity disorder or attention deficit disorder.
- Has taken any investigational drug within 12 weeks prior to the Screen Phase.
- Is sexually active.
- Is either pregnant (i.e., confirmed by pregnancy test at Screen) or breastfeeding.
- Has a clinically significant chronic medical disorder which the investigator and/or GSK medical monitor determine warrants exclusion.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Buffalo, New York, 14222
GSK Investigational Site
Chapel Hill, North Carolina, 27599-7600
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Germantown, Tennessee, 38138
GSK Investigational Site
Greenville, North Carolina, 27834
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Loxahatchee Groves, Florida, 33470
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Melbourne, Florida, 32901
GSK Investigational Site
Milwaukee, Wisconsin, 53215
GSK Investigational Site
Milwaukee, Wisconsin, 53226
GSK Investigational Site
Nashville, Tennessee, 37212
GSK Investigational Site
Newark, New Jersey, 07103
GSK Investigational Site
Panama City, Florida, 32405
GSK Investigational Site
Portland, Oregon, 97239
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Rochester, New York, 14642
GSK Investigational Site
San Jose, California, 95128
GSK Investigational Site
Seattle, Washington, 98105
GSK Investigational Site
Springfield, Missouri, 65804
GSK Investigational Site
Tallahassee, Florida, 32308
GSK Investigational Site
Tampa, Florida, 33607-6350
About this study
Official title: Evaluation of Lamotrigine in Subjects With Absence Seizures
This is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the treatment of newly-diagnosed typical absence seizures. Subjects will be children and adolescents < 13 years of age. It will be conducted at multiple sites in the US. The study will consist of 4 phases: Screen Phase (up to 1 week), Baseline Phase (24 hours), Escalation Phase (up to 20 weeks) and Maintenance Phase (12 weeks). Subjects will receive increasing doses of LTG according to the dosing schedule until attaining seizure freedom as confirmed by hyperventilation (HV) for clinical signs and a 1-hr EEG at 2 consecutive weekly visits. At that point, subjects will move into the 12-week Maintenance Phase. Subjects who do not achieve seizure freedom upon reaching the maximum dose (10.2mg/kg/day) with the specified dose escalation will be discontinued from the study. During the Maintenance Phase, the investigators will use their best effort to maintain the subjects at the efficacious dose reached. If the subjects have unacceptable side effects or inadequate seizure control, the doses of study drug can be increased or decreased as specified in the dosing schedule. Safety will be assessed by monitoring adverse events, laboratory assessments, and serum lamotrigine levels. Health outcomes assessments will also be conducted.
- Conditions
- Seizure, Absence
- Being tested
- Lamotrigine
- Keywords
- Absence Seizures, EEG, LTG, Typical Absence Epilepsy, Epilepsy, LAMICTAL
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamotrigineDrug
Lamotrigine will be given as chewable dispersible tablets with dosing strengths of 2, 5, 25, and 100 milligrams.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving lamotrigine | Experimental | Eligible subjects will receive chewable dispersible tablets of lamotrigine with a starting dose of 0.3 milligrams per kilogram administered orally. Receives: Drug: Lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with no typical absence seizures for two consecutive weeks as confirmed by hyperventilation (HV) for clinical signs and 1-hour electroencephalogram (EEG)
Measured: Up to 8 months
Secondary outcomes (1)
Freq of seizures pre/post-treatment with lamotrigine, proportion of subjects with >=25, 50 and 75% decrease in seizure frequency, proportion of subjects with >=25, 50 and 75% decrease in clinical signs.
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study start1 Nov 2004
- Primary completion22 Apr 2006
- Study completion22 Apr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seizure, AbsenceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 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
- NCT00144872
- Sponsor's protocol ID
- LAM100118
- Status last verified
- Sep 2017
- First submitted
- 1 Sep 2005
- Last updated
- 29 Sep 2017
- Results posted
- 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.
Publications
Holmes GL, Frank LM, Sheth RD, Philbrook B, Wooten JD, Vuong A, Kerls S, Hammer AE, Messenheimer J. Lamotrigine monotherapy for newly diagnosed typical absence seizures in children. Epilepsy Res. 2008 Dec;82(2-3):124-32. doi: 10.1016/j.eplepsyres.2008.07.016. Epub 2008 Sep 7.
PubMed 18778916
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lamotrigine in Subjects With Absence Seizures
- ClinicalTrials.gov ID
- NCT00144872
- Acronym / sponsor ID
- LAM100118
- Conditions
- Seizure, Absence
- Keywords
- Absence Seizures, EEG, LTG, Typical Absence Epilepsy, Epilepsy, LAMICTAL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2004 (actual)
- Primary completion
- 22 Apr 2006 (actual)
- Study completion
- 22 Apr 2006 (actual)
- First posted
- 5 Sep 2005 (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 is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the treatment of newly-diagnosed typical absence seizures. Subjects will be children and adolescents < 13 years of age. It will be conducted at multiple sites in the US. The study will consist of 4 phases: Screen Phase (up to 1 week), Baseline Phase (24 hours), Escalation Phase (up to 20 weeks) and Maintenance Phase (12 weeks). Subjects will receive increasing doses of LTG according to the dosing schedule until attaining seizure freedom as confirmed by hyperventilation (HV) for clinical signs and a 1-hr EEG at 2 consecutive weekly visits. At that point, subjects will move into the 12-week Maintenance Phase. Subjects who do not achieve seizure freedom upon reaching the maximum dose (10.2mg/kg/day) with the specified dose escalation will be discontinued from the study. During the Maintenance Phase, the investigators will use their best effort to maintain the subjects at the efficacious dose reached. If the subjects have unacceptable side effects or inadequate seizure control, the doses of study drug can be increased or decreased as specified in the dosing schedule. Safety will be assessed by monitoring adverse events, laboratory assessments, and serum lamotrigine levels. Health outcomes assessments will also be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving lamotrigine | Experimental | Drug: LamotrigineEligible subjects will receive chewable dispersible tablets of lamotrigine with a starting dose of 0.3 milligrams per kilogram administered orally. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Newly-diagnosed with absence epilepsy and never been treated with Anti-epileptic drugs (AEDs).
- Diagnosis demonstrated on one of two 5-minute hyperventilation tests.
- Investigator must judge that the subject and parent/guardian are likely to comply with all study procedures.
- Parent/guardian must given written informed consent. Subjects who are intellectually able to understand the concepts and procedures of the protocol must give assent by also signing the consent or by signing a separate assent form.
- Results of all screen assessments are judged to be clinically acceptable to the investigator and do not indicate any reasons why entry into the study would be contraindicated.
Key exclusion criteria (11 listed)
- Seizures are the result of a currently active, known, and identifiable intracerebral lesion.
- Has partial or generalized tonic-clonic seizures.
- Has a progressive neurological disorder defined as being unstable for at least 12 weeks prior to the Screen Phase.
- Has a psychiatric disorder requiring medication, or has had a past psychiatric condition that was both judged to be severe and required hospitalization.
- Has any clinically significant chronic cardiac, renal, or hepatic medical condition.
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 |
|---|---|---|
| LamotrigineLamotrigine will be given as chewable dispersible tablets with dosing strengths of 2, 5, 25, and 100 milligrams. | Drug | Subjects receiving lamotrigine |
Primary outcome
The proportion of subjects with no typical absence seizures for two consecutive weeks as confirmed by hyperventilation (HV) for clinical signs and 1-hour electroencephalogram (EEG)
Time frame: Up to 8 months
1 secondary outcome
Freq of seizures pre/post-treatment with lamotrigine, proportion of subjects with >=25, 50 and 75% decrease in seizure frequency, proportion of subjects with >=25, 50 and 75% decrease in clinical signs.
Time frame: Up to 8 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 29 Sep 2017.
- Derived from this study: PubMed 18778916Holmes GL, Frank LM, Sheth RD, Philbrook B, Wooten JD, Vuong A, Kerls S, Hammer AE, Messenheimer J. Lamotrigine monotherapy for newly diagnosed typical absence seizures in children. Epilepsy Res. 2008 Dec;82(2-3):124-32. doi: 10.1016/j.eplepsyres.2008.07.016. Epub 2008 Sep 7.
- Results for study LAM100118 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- 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.
Related trials for Seizure, Absence
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RecruitingPhase 2
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Absence Epilepsy, Jeavons Syndrome
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
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lamotrigine in people with Seizure, Absence, run by GlaxoSmithKline at 23 sites in United States.
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 5 inclusion and 11 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 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 proportion of subjects with no typical absence seizures for two consecutive weeks as confirmed by hyperventilation (HV) for clinical signs and 1-hour electroencephalogram (EEG) (time frame: Up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144872, which also lists 1 linked publication.
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 29 Sep 2017.