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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

WEUSKOP6166: Lamotrigine and Aseptic Meningitis

Completed
Conditions
Epilepsy
Interventions
First Posted Date
2012-08-06
Last Posted Date
2012-08-06
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
1
Registration Number
NCT01657864

Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fed Condition

Phase 1
Completed
Conditions
Fed
Interventions
First Posted Date
2012-06-13
Last Posted Date
2012-06-13
Lead Sponsor
IPCA Laboratories Ltd.
Target Recruit Count
28
Registration Number
NCT01618825
Locations
🇮🇳

Cliantha Research Limited, Ahmedabad, Gujarat, India

Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fasting Condition

Phase 1
Completed
Conditions
Fasting State
Interventions
First Posted Date
2012-06-13
Last Posted Date
2012-06-13
Lead Sponsor
IPCA Laboratories Ltd.
Target Recruit Count
28
Registration Number
NCT01618799
Locations
🇮🇳

Cliantha Research Limited, Ahmedabad, Gujarat, India

WEUKBRE5557: IMI PROTECT(Work Package 2): Antiepileptics & Suicide

Completed
Conditions
Epilepsy
Interventions
First Posted Date
2012-05-30
Last Posted Date
2015-03-27
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
1
Registration Number
NCT01607333

Lamotrigine Phase III Study in Bipolar I Disorder

Phase 3
Completed
Conditions
Bipolar Disorder
Interventions
Drug: Placebo
First Posted Date
2012-05-21
Last Posted Date
2017-01-23
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
265
Registration Number
NCT01602510
Locations
🇨🇳

GSK Investigational Site, Shanghai, China

Sequential Multiple Assignment Treatment for Bipolar Disorder

Phase 4
Completed
Conditions
Bipolar I Disorder
Bipolar II Disorder
Interventions
First Posted Date
2012-05-01
Last Posted Date
2020-08-19
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
112
Registration Number
NCT01588457
Locations
🇺🇸

Case Western Reserve University, Cleveland, Ohio, United States

🇺🇸

University of Texas Health Science Center, San Antonio, Texas, United States

Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fasting Condition

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2012-01-20
Last Posted Date
2012-01-20
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
20
Registration Number
NCT01513720
Locations
🇺🇸

AAI Clinic, Quadrangle drive, North Carolina, United States

Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2012-01-20
Last Posted Date
2012-01-20
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
20
Registration Number
NCT01513681
Locations
🇺🇸

AAI Clinic, Quadrangle drive, North Carolina, United States

Decision-Making in Bipolar Disorder

Not Applicable
Completed
Conditions
Bipolar Disorder
Interventions
First Posted Date
2011-11-01
Last Posted Date
2017-05-31
Lead Sponsor
Emory University
Target Recruit Count
37
Registration Number
NCT01463111
Locations
🇺🇸

Emory University Mood and Anxiety Disorders Program, Atlanta, Georgia, United States

Clinical Study of Lamotrigine to Treat Newly Diagnosed Typical Absence Seizure in Children and Adolescents

Phase 3
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2011-09-12
Last Posted Date
2017-03-08
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
20
Registration Number
NCT01431976
Locations
🇰🇷

GSK Investigational Site, Seoul, Korea, Republic of

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