Epilepsy, Tonic-ClonicPhase 4NCT00043901
Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug
A Phase 4 study testing lamotrigine in people with Epilepsy, Tonic-Clonic, run by GlaxoSmithKline at 87 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC) seizures. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Epilepsy, Tonic-Clonic
- What is being tested?
- lamotrigine
- How many people
- 141 participants
- Where
- 87 sitesin 4 countries
- Study dates
- 1 Dec 2000to 1 Mar 2005
- Phase
- Phase 4
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Weigh at least 13kg.
- Have a confident diagnosis of epilepsy with primary generalized tonic-clonic (PGTC) seizures with or without other generalized seizure types.
- Currently being treated with an antiepileptic drug(s) (AED).
- Benzodiazepines are allowed with some frequency restrictions.
- Vagus nerve stimulation is allowed if in place for at least 6 months prior to starting the study with no changes to the settings having occured during the month immediately prior to starting the study, and if no changes will occur during all phases of the study.
- History of primary generalized tonic-clonic seizures with no focal onset.
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- Have at least 1 primary generalized tonic-clonic (PGTC) seizure during the 8 consecutive weeks prior to the baseline period of the study.
- Have at least 3 PGTC seizures occur anytime during the 8-week baseline phase of the study.
- Females must agree to acceptable form of birth control.
Who cannot join
- A history of partial seizures or interictal expression of partial seizures as evidenced by electroencephalogram.
- Have Lennox-Gastaut syndrome.
- Currently using or has previously used the drug being studied.
- Is abusing alcohol and/or other substance(s).
- Has taken an investigational drug during the 30 days prior to the study or plans to take an investigational drug anytime during the study.
- Is receiving chronic (long-term) treatment with any medication that could influence seizure control.
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- Follows the ketogenic diet.
- Is planning surgery to control seizures during the study.
- Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormality.
- Has any clinically significant heart, kidney, or liver condition, or a condition that affects how drugs are absorbed, distributed, metabolized, or removed from the body.
Trial locations and contacts
87 sites in 4 countries.
87 sites in 4 countries
United States80 sites
GSK Investigational Site
Alabaster, Alabama, 35007
GSK Investigational Site
Albany, New York, 12205
GSK Investigational Site
Arlington, Texas, 76015
GSK Investigational Site
Asheville, North Carolina, 28801
GSK Investigational Site
Atlanta, Georgia, 30309
GSK Investigational Site
Atlanta, Georgia, 30338
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Bakersfield, California, 93309
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Bennington, Vermont, 05201
GSK Investigational Site
Boise, Idaho, 83712
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Charlotte, North Carolina, 28207
GSK Investigational Site
Cherry Hill, New Jersey, 8034
GSK Investigational Site
Chicago, Illinois, 60637-1470
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Cleveland, Ohio, 44195
GSK Investigational Site
Crestview Hills, Kentucky, 41017
GSK Investigational Site
Dallas, Texas, 75235
GSK Investigational Site
Danville, Pennsylvania, 17822-4201
GSK Investigational Site
Danville, Virginia, 24541
GSK Investigational Site
Denver, Colorado, 80218
GSK Investigational Site
Detroit, Michigan, 48202
GSK Investigational Site
Farmington Hills, Michigan, 48334
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Gainsville, Florida, 32611
GSK Investigational Site
Germantown, Tennessee, 38138
GSK Investigational Site
Greenville, North Carolina, 27834
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Idaho Falls, Idaho, 83404
GSK Investigational Site
Indianapolis, Indiana, 46202 - 5111
GSK Investigational Site
Irvine, California, 92618
GSK Investigational Site
Kansas City, Missouri, 64108
GSK Investigational Site
Las Vegas, Nevada, 89102
GSK Investigational Site
Lexington, Kentucky, 40503
GSK Investigational Site
Lexington, Kentucky, 40536-0284
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Madison, Wisconsin, 53715
GSK Investigational Site
Marshfield, Wisconsin, 54449
GSK Investigational Site
Medford, New Jersey, 08055
GSK Investigational Site
Medford, Oregon, 97504-8456
GSK Investigational Site
Memphis, Tennessee, 38119
GSK Investigational Site
Miami, Florida, 33125
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Milwaukee, Wisconsin, 53226
GSK Investigational Site
Minneapolis, Minnesota, 55422
GSK Investigational Site
Mobile, Alabama, 36693
GSK Investigational Site
Mount Vernon, New York, 10550
GSK Investigational Site
Nashville, Tennessee, 37212
GSK Investigational Site
Natrona Heights, Pennsylvania, 15065
GSK Investigational Site
New Brunswick, New Jersey, 8903
GSK Investigational Site
Newark, Delaware, 19713
GSK Investigational Site
Newport News, Virginia, 23601
GSK Investigational Site
Newton, Massachusetts, 02459
GSK Investigational Site
Northport, Alabama, 35476
GSK Investigational Site
Northridge, California, 91325
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
GSK Investigational Site
Orlando, Florida, 32835
GSK Investigational Site
Panama City, Florida, 32405
GSK Investigational Site
Portland, Oregon, 97201-2984
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Sacramento, California, 95871
GSK Investigational Site
Saint Cloud, Minnesota, 56303
GSK Investigational Site
Salt Lake City, Utah, 84102
GSK Investigational Site
Salt Lake City, Utah, 84113
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Sharon, Massachusetts, 02067
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Springfield, Illinois, 62702
GSK Investigational Site
Springfield, Missouri, 65807
GSK Investigational Site
St Louis, Missouri, 63110-1093
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
Tallahassee, Florida, 32308
GSK Investigational Site
Tampa, Florida, 33607-6350
GSK Investigational Site
Toledo, Ohio, 43614-5809
GSK Investigational Site
Washington D.C., District of Columbia, 20037
GSK Investigational Site
West Palm Beach, Florida, 33407
GSK Investigational Site
Wichita, Kansas, 67214
GSK Investigational Site
Winston-Salem, North Carolina, 27157
Argentina4 sites
GSK Investigational Site
Buenos Aires, Buenos Aires, 1181
GSK Investigational Site
Buenos Aires, Buenos Aires, 1221
GSK Investigational Site
Buenos Aires, Buenos Aires, C1428AQK
GSK Investigational Site
Capital Federal
Chile2 sites
GSK Investigational Site
Santiago, Región Metro de Santiago
GSK Investigational Site
Valparaíso, Valparaiso, 2341131
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects Wtih Primary Generalized Tonic-Clonic Seizures
The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC) seizures.
- Conditions
- Epilepsy, Tonic-Clonic
- Being tested
- lamotrigine
- Keywords
- PGTC, Lamotrigine, epilepsy, seizures, primary generalized tonic-clonic
- Medical subject headings
- Epilepsy, Tonic-Clonic, 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.
% change from Baseline in average monthly PGTC seizure frequency
Secondary outcomes (1)
Proportion of subjects with >/= 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2002 (estimated)
- Study start1 Dec 2000
- Primary completion1 Nov 2003
- Study completion1 Mar 2005
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 Epilepsy, Tonic-ClonicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 141 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
- NCT00043901
- Sponsor's protocol ID
- LAM40097
- Status last verified
- Mar 2017
- First submitted
- 14 Aug 2002
- Last updated
- 4 Apr 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
Biton V, Sackellares JC, Vuong A, Hammer AE, Barrett PS, Messenheimer JA. Double-blind, placebo-controlled study of lamotrigine in primary generalized tonic-clonic seizures. Neurology. 2005 Dec 13;65(11):1737-43. doi: 10.1212/01.wnl.0000187118.19221.e4.
PubMed 16344515
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects Wtih Primary Generalized Tonic-Clonic Seizures
- ClinicalTrials.gov ID
- NCT00043901
- Acronym / sponsor ID
- LAM40097
- Conditions
- Epilepsy, Tonic-Clonic
- Keywords
- PGTC, Lamotrigine, epilepsy, seizures, primary generalized tonic-clonic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2000
- Primary completion
- 1 Nov 2003 (actual)
- Study completion
- 1 Mar 2005 (actual)
- First posted
- 16 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.
The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC) seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Weigh at least 13kg.
- Have a confident diagnosis of epilepsy with primary generalized tonic-clonic (PGTC) seizures with or without other generalized seizure types.
- Currently being treated with an antiepileptic drug(s) (AED).
- Benzodiazepines are allowed with some frequency restrictions.
- Vagus nerve stimulation is allowed if in place for at least 6 months prior to starting the study with no changes to the settings having occured during the month immediately prior to starting the study, and if no changes will occur during all phases of the study.
Key exclusion criteria (10 listed)
- A history of partial seizures or interictal expression of partial seizures as evidenced by electroencephalogram.
- Have Lennox-Gastaut syndrome.
- Currently using or has previously used the drug being studied.
- Is abusing alcohol and/or other substance(s).
- Has taken an investigational drug during the 30 days prior to the study or plans to take an investigational drug anytime during 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
% change from Baseline in average monthly PGTC seizure frequency
1 secondary outcome
Proportion of subjects with >/= 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency.
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 4 Apr 2017.
- Results publication: PubMed 16344515Biton V, Sackellares JC, Vuong A, Hammer AE, Barrett PS, Messenheimer JA. Double-blind, placebo-controlled study of lamotrigine in primary generalized tonic-clonic seizures. Neurology. 2005 Dec 13;65(11):1737-43. doi: 10.1212/01.wnl.0000187118.19221.e4.
- 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 Epilepsy, Tonic-Clonic
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RecruitingPhase 3
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
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Enrolling by invitationPhase 3
Clinical Trial of Vormatrigine in Adult Patients With Epilepsy
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Active, not recruitingPhase 3
A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.
CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure
RecruitingPhase 3
LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome
Down Syndrome, Down Syndrome (DS)
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
87 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lamotrigine in people with Epilepsy, Tonic-Clonic, run by GlaxoSmithKline at 87 sites in 4 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 9 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in United States, Argentina, Chile, Peru. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
% change from Baseline in average monthly PGTC seizure frequency. 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 NCT00043901, 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 4 Apr 2017.