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

Effect of Lamotrigine on Cognition in NF1

Phase 2
Terminated
Conditions
Neurofibromatosis Type 1
Interventions
Drug: Placebo
First Posted Date
2014-10-03
Last Posted Date
2020-04-14
Lead Sponsor
Erasmus Medical Center
Target Recruit Count
41
Registration Number
NCT02256124
Locations
🇧🇪

University Hospital Leuven, Leuven, Belgium

🇳🇱

Erasmus Medical Center, Rotterdam, South Holland, Netherlands

🇪🇸

Hospital Sant Joan de Deu, Barcelona, Spain

Study of Lamotrigine to Treat Ménière's Disease

Phase 2
Completed
Conditions
Meniere's Disease
Ménière's Vertigo
Vertigo, Intermittent
Vertigo, Aural
Interventions
Drug: Placebo
First Posted Date
2014-06-09
Last Posted Date
2022-06-22
Lead Sponsor
Dent Neuroscience Research Center
Target Recruit Count
15
Registration Number
NCT02158585
Locations
🇺🇸

Dent Neurologic Institute, Amherst, New York, United States

Valproate Dose Reduction and Its Clinical Evaluation by Introducing Lamotrigine in Japanese Women With Epilepsy - Single Arm, Multicenter, and Open-label Study

Phase 4
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2014-04-01
Last Posted Date
2017-11-17
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
33
Registration Number
NCT02100644
Locations
🇯🇵

GSK Investigational Site, Tokyo, Japan

Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?

Phase 1
Completed
Conditions
Bipolar Disorder
Manic Depression
Interventions
First Posted Date
2014-03-07
Last Posted Date
2018-08-01
Lead Sponsor
San Diego Veterans Healthcare System
Target Recruit Count
8
Registration Number
NCT02081287
Locations
🇺🇸

VA San Diego Healthcare System, San Diego, California, United States

The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 100mg Compared With Compressed Tablet 100 mg

First Posted Date
2014-02-17
Last Posted Date
2017-05-10
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
138
Registration Number
NCT02064465
Locations
🇨🇳

GSK Investigational Site, Shanghai, China

Pregnant Women Taking Lamictal for Bipolar Disorder

Completed
Conditions
Bipolar Disorder
Interventions
First Posted Date
2013-11-27
Last Posted Date
2022-09-28
Lead Sponsor
Northwestern University
Target Recruit Count
30
Registration Number
NCT01996293
Locations
🇺🇸

Northwestern Memorial Hospital, Chicago, Illinois, United States

Lamotrigine Bioequivalence

Phase 4
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2013-11-27
Last Posted Date
2020-12-01
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
35
Registration Number
NCT01995825
Locations
🇺🇸

University of Maryland, Baltimore, Maryland, United States

Lamotrigine as Treatment of Myotonia

Phase 3
Completed
Conditions
Potassium-Aggravated Myotonia
Myotonia Congenita
Dystrophia Myotonica Type 1
Paramyotonia Congenita
Hyperkalemic Periodic Paralysis
Interventions
Drug: Placebo
First Posted Date
2013-09-11
Last Posted Date
2016-04-25
Lead Sponsor
Grete Andersen, MD
Target Recruit Count
27
Registration Number
NCT01939561
Locations
🇩🇰

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

Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)

Phase 3
Terminated
Conditions
Epilepsy, Partial
Epilepsy, Localization Related
Interventions
First Posted Date
2013-07-03
Last Posted Date
2017-09-19
Lead Sponsor
Emory University
Target Recruit Count
72
Registration Number
NCT01891890
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

🇺🇸

Cincinnati Children's Hospital, Cincinnati, Ohio, United States

and more 11 locations

Bioequivalence Study of Lamotrigine Extended-Release Tablets 50 mg Under Fasting Condition

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2013-06-28
Last Posted Date
2013-06-28
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
62
Registration Number
NCT01888731
Locations
🇮🇳

Bioserve Clinical Research Private Limited, Balanagar, Hyderabad, India

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