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

A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2016-07-01
Last Posted Date
2020-05-01
Lead Sponsor
Food and Drug Administration (FDA)
Target Recruit Count
30
Registration Number
NCT02821338
Locations
🇺🇸

Vince and Associates Clinical Research, Inc, Overland Park, Kansas, United States

The Sustained Effects of Ketamine

Phase 1
Terminated
Conditions
Mental Disorders
Interventions
First Posted Date
2016-03-15
Last Posted Date
2020-07-02
Lead Sponsor
Yale University
Target Recruit Count
3
Registration Number
NCT02708849
Locations
🇺🇸

Yale Center for Clinical Investigation, Yale University, New Haven, Connecticut, United States

Characterization of Epilepsy Patients BEEP 2b

First Posted Date
2016-03-14
Last Posted Date
2020-03-27
Lead Sponsor
Food and Drug Administration (FDA)
Target Recruit Count
21
Registration Number
NCT02707965
Locations
🇺🇸

University of Maryland, Baltimore, Baltimore, Maryland, United States

Lamotrigine for Ketamine Dependence Trial

Phase 2
Completed
Conditions
Addiction
Interventions
Drug: Placebo
First Posted Date
2015-09-22
Last Posted Date
2018-02-01
Lead Sponsor
Taipei City Hospital
Target Recruit Count
30
Registration Number
NCT02556060
Locations
🇨🇳

Taipei City Hospital and Psychiatric Center, Taipei, Taiwan

Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects

Phase 1
Completed
Conditions
Bipolar Disorder
Interventions
First Posted Date
2015-07-31
Last Posted Date
2017-05-08
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
16
Registration Number
NCT02513654
Locations
🇨🇳

GSK Investigational Site, Shanghai, China

BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients

Phase 4
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2015-03-31
Last Posted Date
2019-08-19
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
4
Registration Number
NCT02404168
Locations
🇺🇸

University of Maryland, Baltimore, Maryland, United States

16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression

Phase 4
Terminated
Conditions
Bipolar Disorder
Interventions
First Posted Date
2015-03-17
Last Posted Date
2019-06-19
Lead Sponsor
Mayo Clinic
Target Recruit Count
2
Registration Number
NCT02389712
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Pharmacovigilance in Gerontopsychiatric Patients

Phase 3
Terminated
Conditions
Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders
Interventions
First Posted Date
2015-03-02
Last Posted Date
2018-02-28
Lead Sponsor
Hannover Medical School
Target Recruit Count
407
Registration Number
NCT02374567
Locations
🇩🇪

Bezirkskrankenhaus Augsburg, Augsburg, Germany

🇩🇪

Krankenhaus Hedwigshöhe, Berlin, Germany

🇩🇪

Hannover Medical School, Hannover, Germany

and more 2 locations

Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

Phase 4
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-11-27
Last Posted Date
2015-04-22
Lead Sponsor
Per Damkier
Target Recruit Count
12
Registration Number
NCT02303106
Locations
🇩🇰

University of Southern Denmark, Odense, Denmark

Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Lamotrigine.

Phase 1
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2014-11-05
Last Posted Date
2014-11-05
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
32
Registration Number
NCT02283801
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