MedPath

Lamotrigine

Generic Name
Lamotrigine
Brand Names
Lamictal
Drug Type
Small Molecule
Chemical Formula
C9H7Cl2N5
CAS Number
84057-84-1
Unique Ingredient Identifier
U3H27498KS
Background

Lamotrigine is an antiepileptic drug belonging in the phenyltriazine class. It is used in the treatment of both epilepsy and as a mood stabilizer in bipolar disorder. Lamotrigine is the first medication since lithium granted Food and Drug Administration (FDA) approval for the maintenance treatment of bipolar type I. It is approved for use in more than 30 countries.

Lamotrigine has relatively few side-effects and does not require laboratory monitoring. While it is indicated for epilepsy and bipolar disorders, there is evidence that lamotrigine could have some clinical efficacy in certain neuropathic pain states.

Indication

Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients ≥2 years of age: partial seizures, primary generalized tonic-clonic seizures, and generalized seizures due to Lennox-Gastaut syndrome.

It is also indicated for the process of conversion to drug monotherapy for those at least 16 years of age or older with partial seizures and currently are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).

In addition to the above, lamotrigine is also indicated for the maintenance treatment of bipolar I disorder, delaying the time to mood episodes (which may include mania, hypomania, depression, mixed episodes) in adults at least 18 years or older, who have been treated for acute mood symptoms with standard therapy.

Limitations of use

It is important to note that lamotirigine should not be used in the treatment of acute mood episodes, as efficacy has not been established in this context.

Associated Conditions
Bipolar 1 Disorder, Generalized Tonic-Clonic Seizures, Partial-Onset Seizures, Seizures, Generalized
Associated Therapies
Conversion to monotherapy

Single-dose, Two-way Crossover Bioequivalence of Lamotrigine in Healthy Male Volunteers Under Fasting Conditions

Phase 1
Completed
Conditions
Fasting
Interventions
First Posted Date
2024-01-10
Last Posted Date
2024-01-10
Lead Sponsor
Desitin Arzneimittel GmbH
Target Recruit Count
24
Registration Number
NCT06199791
Locations
🇨🇦

Biopharma Services INC, Toronto, Canada

Lithium Versus Lamotrigine in Bipolar Disorder, Type II

Phase 4
Recruiting
Conditions
Bipolar II Disorder
Interventions
First Posted Date
2023-12-28
Last Posted Date
2024-06-07
Lead Sponsor
Mental Health Services in the Capital Region, Denmark
Target Recruit Count
200
Registration Number
NCT06184581
Locations
🇩🇰

Psychiatric Center Copenhagen, Copenhagen, Denmark

Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy: Clinicolabratory Study

Phase 4
Not yet recruiting
Conditions
Epilepsy
Lamotrigine
Sodium Valproate Adverse Reaction
Interventions
Drug: Sodium Valproate 500 Mg Prolonged-Release Oral Tablet
Device: E.E.G
First Posted Date
2023-05-31
Last Posted Date
2024-07-30
Lead Sponsor
Assiut University
Target Recruit Count
50
Registration Number
NCT05881928

The Efficacy and Safety of Lamotrigine Versus Carbamazepine in Focal Epilepsy

Phase 4
Conditions
Focal Epilepsy
Interventions
Drug: Carbamazepine-Containing Product in Oral Dose Form
First Posted Date
2023-02-28
Last Posted Date
2023-10-10
Lead Sponsor
Dhaka Medical College
Target Recruit Count
70
Registration Number
NCT05748236
Locations
🇧🇩

Dhaka medical college, Dhaka, Bangladesh

The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children

First Posted Date
2023-01-26
Last Posted Date
2023-01-26
Lead Sponsor
Dr Cipto Mangunkusumo General Hospital
Target Recruit Count
100
Registration Number
NCT05697614
Locations
🇮🇩

Cipto Mangunkusumo Hospital, Jakarta Pusat, Jakarta, Indonesia

🇮🇩

Harapan Kita Hospital, Jakarta, Indonesia

🇮🇩

Fatmawati Hospital, Jakarta, Indonesia

Treatment of Myotonia - Lamotrigine Versus Namuscla

Not Applicable
Recruiting
Conditions
Non-Dystrophic Myotonia
Interventions
First Posted Date
2022-12-06
Last Posted Date
2022-12-06
Lead Sponsor
Grete Andersen, MD
Target Recruit Count
32
Registration Number
NCT05639257
Locations
🇩🇰

Copenhagen Neuromuscular Center, department of Neurology, Rigshospitalet, Copenhagen, Denmark

Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding

Recruiting
Conditions
Epilepsy
Pregnancy Related
Interventions
First Posted Date
2022-07-11
Last Posted Date
2025-04-18
Lead Sponsor
University of Pittsburgh
Target Recruit Count
60
Registration Number
NCT05450978
Locations
🇺🇸

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

Precision Medicine in the Treatment of Epilepsy

First Posted Date
2022-07-11
Last Posted Date
2024-04-11
Lead Sponsor
Gitte Moos Knudsen
Target Recruit Count
550
Registration Number
NCT05450822
Locations
🇩🇰

Neurobiology Research Unit, Rigshospitalet, Copenhagen, Denmark

Lamotrigine and Bupropion for Meniere's Disease

Phase 2
Recruiting
Conditions
Meniere Disease
Ménière's Vertigo
Vertigo, Intermittent
Vertigo, Aural
Interventions
First Posted Date
2022-06-15
Last Posted Date
2022-06-21
Lead Sponsor
Dent Neuroscience Research Center
Target Recruit Count
34
Registration Number
NCT05420350
Locations
🇺🇸

Dent Neurologic Institute, Amherst, New York, United States

Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg

Phase 1
Completed
Conditions
Bioequivalence
Interventions
First Posted Date
2021-12-06
Last Posted Date
2021-12-07
Lead Sponsor
Alembic Pharmaceuticals Ltd.
Target Recruit Count
22
Registration Number
NCT05145608
Locations
🇨🇦

Algorithme Pharma, Mount Royal, Quebec, Canada

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