Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lamictal · 5 trials · 3 indications
Participants were considered to be seizure free if they did not report any seizures during the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic-clonic seizures are a type of generalized seizure that affects the entire brain.
EEG is a diagnostic test for epilepsy. The EEG machine records the brain's electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes using a pin-wheel provided to them.
TOBE was defined by the first prescription of any additional pharmacotherapy to treat bipolar symptoms, increasing the dose(s) of the participants conventional bipolar medication(s), treatment with electroconvulsive therapy, or moving the participant to a more restricted environment for observation, safety, or treatment; or participant withdrawal from the study due to a bipolar-related adverse event (AE) or serious adverse event (SAE); or participants withdrawal from the study due to lack of efficacy as defined by rating scale threshold scores. TOBE was calculated using a log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).
Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing "rash"; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the "Skin and Subcutaneous Tissue Disorders" system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection.
| Arm | Type | Description |
|---|---|---|
| Lamotrigine | EXPERIMENTAL | No comparison. |
| placebo | PLACEBO_COMPARATOR | Placebo Controlled |
| lamictal | EXPERIMENTAL | Flexible Dosing |
| Name | Type | Description |
|---|---|---|
| Lamictal | DRUG | No comparison. |
| LAMICTAL extended-release | DRUG | - |
Inclusion Criteria: 1. Target disease: Subjects with newly diagnosed epilepsy or recurrent epilepsy which is untreated, having the following seizure types as classified by the International Classification of Seizures. * Partial seizures (with or without secondarily generalisation) * Generali...
Lamictal is used for epilepsy and bipolar disorder. It is a small molecule developed by GSK plc (GSK) for neurological conditions. In epilepsy, it is studied for newly diagnosed epilepsy and typical absence seizures. In bipolar disorder, it is studied as an add-on treatment for bipolar I disorder in pediatric patients.
Lamictal targets sodium channels in the brain. By inhibiting voltage-sensitive sodium channels, it stabilizes neuronal membranes and modulates the release of excitatory neurotransmitters. This action helps control abnormal electrical activity associated with seizures and mood episodes in epilepsy and bipolar disorder.
Lamictal is developed by GSK plc, a global pharmaceutical company traded under the ticker GSK. GSK is responsible for the clinical development and commercialization of Lamictal for epilepsy and bipolar disorder.
Lamictal is in Phase 3 clinical development. It has completed three Phase 3 trials, with no active trials currently ongoing. These trials have been completed across epilepsy and bipolar disorder indications, with a total enrollment of 301 participants.
Lamictal has completed three Phase 3 trials. NCT00395694 evaluated BW430C in epilepsy in Japan. NCT00723450 studied Lamictal as add-on treatment for bipolar I disorder in pediatric patients in the United States. NCT01431963 and NCT01431976 studied lamotrigine for newly diagnosed epilepsy and typical absence seizures in Japan and South Korea.
Lamictal is the brand name for lamotrigine. Clinical trials listed under NCT01431963 and NCT01431976 use the generic name lamotrigine, while other trials use the brand name Lamictal. Both refer to the same active pharmaceutical ingredient.