Product Description
Lamotrigine (Lamictal), a phenyltriazine derivative, is a well established anticonvulsant agent that has shown efficacy in the prevention of mood episodes in adult patients with bipolar I disorder. The mechanism of action of the drug in patients with bipolar disorder may be related to the inhibition of sodium and calcium channels in presynaptic neurons and subsequent stabilisation of the neuronal membrane. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/12962521/)
Mechanisms of Action: HCN Agonist,Calcium Channel Blocker,Sodium Channel Blocker
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Epilepsy | Epilepsy, Generalized | Lennox Gastaut Syndrome | Seizures | Bipolar Disorder | Conversion Disorder | Seizures
Known Adverse Events: Epilepsy | Bipolar Disorder | Abdominal Pain | Ataxia | Back Pain | Diplopia | Dizziness | Headache | Pain Unspecified | Tremor | Insomnia | Xerostomia | Pharyngitis | Rhinitis | Diarrhea
Company: GlaxoSmithKline
Company Location: BRENTFORD MIDDLESEX X0 TW8 9GS
Company CEO: Emma Walmsley
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, United States
Active Clinical Trial Count: 7
Highest Development Phases
Phase 3: Bipolar Disorder|Epilepsy|Seizures
Phase 2: Dizziness|Meniere Disease|Vertigo
Phase 1: Healthy Volunteers|Tobacco Use Disorder
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| DBTC-003 | P2 |
Recruiting |
Meniere Disease|Vertigo|Dizziness |
2024-07-01 |
|
| LTG-008/K | P1 |
Completed |
Tobacco Use Disorder |
2023-05-09 |
43% |
| LTG-008/K | P1 |
Completed |
Tobacco Use Disorder |
2023-05-09 |
43% |
| 2016-004954-13 | P3 |
Active, not recruiting |
Epilepsy |
2022-10-05 |
|
| Open study of Lamictal monotherapy for children with absence seizures | P3 |
Active, not recruiting |
Seizures |
2022-09-18 |