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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

Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

Phase 4
Completed
Conditions
Borderline Personality Disorder
Interventions
Drug: Placebo
First Posted Date
2008-03-12
Last Posted Date
2008-03-12
Lead Sponsor
Mclean Hospital
Target Recruit Count
28
Registration Number
NCT00634062
Locations
🇺🇸

McLean Hospital, Belmont, Massachusetts, United States

AED/Statin Interaction Study

Phase 1
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2008-03-03
Last Posted Date
2017-08-04
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
119
Registration Number
NCT00627575
Locations
🇺🇸

GSK Investigational Site, Buffalo, New York, United States

Lamotrigine for Symptoms of Geriatric Bipolar Depression

Phase 3
Completed
Conditions
Bipolar Disorder
Depression, Bipolar
Interventions
First Posted Date
2008-02-22
Last Posted Date
2014-12-30
Lead Sponsor
University Hospitals Cleveland Medical Center
Target Recruit Count
57
Registration Number
NCT00621842
Locations
🇺🇸

University Hospitals Case Medical Center/ Case Western Reserve University, Cleveland, Ohio, United States

🇺🇸

Baylor College of Medicine/Michael E. DeBakey VAMC, Houston, Texas, United States

🇺🇸

Weill Medical College of Cornell University, White Plains, New York, United States

and more 2 locations

Pharmacokinetic Study on Raltegravir and Lamotrigine

Phase 1
Completed
Conditions
HIV Infection
Interventions
First Posted Date
2008-02-19
Last Posted Date
2020-10-19
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
24
Registration Number
NCT00618241
Locations
🇳🇱

Radboud University Medical Center, Nijmegen, Gelderland, Netherlands

Premenstrual Dysphoric Disorder and Antiepileptic Drugs

Completed
Conditions
Epilepsy
Interventions
First Posted Date
2008-02-11
Last Posted Date
2018-10-26
Lead Sponsor
Beth Israel Deaconess Medical Center
Target Recruit Count
80
Registration Number
NCT00612235
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Newton-Wellesley Hospital, Newton, Massachusetts, United States

Bioequivalence and Food Effect of 250mg of Lamotrigine XR

Phase 1
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2008-01-31
Last Posted Date
2017-09-11
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
209
Registration Number
NCT00605371
Locations
🇺🇸

GSK Investigational Site, Tacoma, Washington, United States

An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder

Phase 3
Completed
Conditions
Mood Disorders
Interventions
First Posted Date
2007-12-24
Last Posted Date
2016-12-16
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
97
Registration Number
NCT00579982
Locations
🇺🇸

GSK Investigational Site, Charleston, West Virginia, United States

The Use of Anticonvulsants for Treatment of Patients With Alcohol Dependence and Post Traumatic Stress Disorder

Phase 3
Withdrawn
Conditions
Alcohol Dependence
Post Traumatic Stress Disorder
Interventions
First Posted Date
2007-12-11
Last Posted Date
2020-11-16
Lead Sponsor
Yale University
Registration Number
NCT00571246
Locations
🇺🇸

VA Connecticut Healthcare System, West Haven, Connecticut, United States

An Evaluation Of BW430C (Lamotrigine) Versus Placebo In The Prevention Of Mood Episodes In Bipolar I Disorder Patients

Phase 3
Completed
Conditions
Bipolar Disorder
Interventions
Drug: Placebo
First Posted Date
2007-10-29
Last Posted Date
2016-11-23
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
215
Registration Number
NCT00550407
Locations
🇯🇵

GSK Investigational Site, Yamagata, Japan

Lamotrigine Extended-Release In Elderly Patients With Epilepsy

Phase 3
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2007-08-15
Last Posted Date
2017-01-18
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
122
Registration Number
NCT00516139
Locations
🇺🇸

GSK Investigational Site, Milwaukee, Wisconsin, United States

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