A Phase 4 interventional study of lamotrigine in Epilepsy, Tonic-Clonic, sponsored by GlaxoSmithKline. Completed at 87 sites in 4 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2017-04-04.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
Among 11 studies in Epilepsy, Tonic-Clonic with a site in United States — 1 open to participants now, 2 under way, 2 of them phase 3. Epilepsy, Tonic-Clonic · United States.
Among the 11 studies in Epilepsy, Tonic-Clonic with a site in United States, this one is the 5th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2000, is one of 2 in phase 4, and was the 2nd registered.
23 studies on the registry are indexed under Epilepsy, Tonic-Clonic; 3 are open to participants now.
This study's enrollment of 141 is above the median of 94 across 20 interventional studies indexed under Epilepsy, Tonic-Clonic.
Browse Epilepsy, Tonic-Clonic studies →1 of the 11 studies in Epilepsy, Tonic-Clonic with a site in United States is open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 2 Epilepsy, Tonic-Clonic studies recruiting now, 1 (50%) set no upper age limit and 1 (50%) stop at 75 or younger; 1 take children under 18; 1 take healthy volunteers.
This study: 2 Years and older · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2000.
Median enrollment 134 across the 10 interventional studies, 1,278 across the 1 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
8 of 11 have an industry lead sponsor. The 10 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
GlaxoSmithKline has 3 studies filed under Epilepsy, Tonic-Clonic — fewer than ten, so there is no comparison to draw.
1 of the studies in Epilepsy, Tonic-Clonic with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05064878Phase 3Zogenix, Inc.A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder. | 2027-11-08 |
Among the 11 studies in Epilepsy, Tonic-Clonic with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
% change from Baseline in average monthly PGTC seizure frequency
Proportion of subjects with >/= 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency.
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
The record gives a start of Dec 2000, a primary completion of Nov 2003 and a completion of Mar 2005. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Lamotrigine