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Label indication LAMICTAL is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: • partial-onset seizures. • primary generalized tonic-clonic (PGTC) seizures. • generalized seizures of Lennox-Gastaut syndrome. FDA label
Lamotrigine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Lamotrigine Tablets 25 mg |
| 2 | ACTIVE_COMPARATOR | Lamictal® Tablets 25 mg |
| Name | Type | Description |
|---|---|---|
| Lamotrigine Tablets 25 mg | DRUG | 2x25mg, single dose fed |
| Lamictal® Tablets 25 mg | DRUG | 2x25mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evenin...
Lamotrigine is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is referenced in clinical development as Lamotrigine Tablets 25 mg. The listed development stage is Phase 1. Its therapeutic area is classified as Other, and the specific indications studied in the available trials are not disclosed.
Lamotrigine targets the sodium channel proteins SCN1A, SCN5A, SCN4A, SCN7A, SCN2A, and SCN9A. It is classified as a blocker of this target class. By acting on these voltage-gated sodium channels, the small molecule modulates sodium channel activity.
Lamotrigine is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the company associated with the Lamotrigine Tablets 25 mg program described in its clinical development record.
Lamotrigine is in Phase 1 development. It is an investigational product and is not described as approved. The program has two completed Phase 1 trials and no active trials, with a total enrolled population of 55 participants across those completed studies.
Two completed Phase 1 trials are registered for Lamotrigine: NCT00650208, a fasting study of Lamotrigine Tablets 25 mg versus Lamictal Tablets 25 mg, and NCT00647751, a food study of the same comparison. Both enrolled healthy volunteers in the United States, with 27 and 28 participants respectively.
Lamotrigine Tablets 25 mg is the name used for this product, and its trials compared it directly against Lamictal Tablets 25 mg. Lamictal is the reference product named in those Phase 1 fasting and food studies, so the two names appear together in the trial titles.