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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

Clinical Study of Lamotrigine to Treat Newly Diagnosed Epilepsy

Phase 3
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2011-09-12
Last Posted Date
2016-10-20
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
70
Registration Number
NCT01431963
Locations
🇰🇷

GSK Investigational Site, Seoul, Korea, Republic of

Special Drug Use Investigation for LAMICTAL Bipolar

Completed
Conditions
Bipolar Disorder
Interventions
First Posted Date
2011-09-05
Last Posted Date
2016-04-25
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
1036
Registration Number
NCT01428518

Drug Use Investigation for LAMICTAL

Completed
Conditions
Epilepsy
Interventions
First Posted Date
2011-06-20
Last Posted Date
2016-11-09
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
3000
Registration Number
NCT01376180

Lamotrigine Bioequivalence Study to Compare Dispersible Tables With Compressed Tablets in China

Phase 1
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2011-05-23
Last Posted Date
2017-09-20
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
24
Registration Number
NCT01357902
Locations
🇭🇰

GSK Investigational Site, Shatin, New Territories, Hong Kong

Reversing Corticosteroid Induced Memory Impairment

Phase 4
Completed
Conditions
Memory Impairment
Interventions
Drug: Placebo
First Posted Date
2010-06-11
Last Posted Date
2018-08-27
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
54
Registration Number
NCT01142310
Locations
🇺🇸

Parkland Health and Hospital System (Asthma, Allergy, & Arthritis Clinics), Dallas, Texas, United States

Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fasting Condition

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-05-27
Last Posted Date
2010-06-14
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
26
Registration Number
NCT01131949
Locations
🇺🇸

AAI Clinic, Chapel Hill, North Carolina, United States

Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-05-27
Last Posted Date
2010-06-14
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
26
Registration Number
NCT01131975
Locations
🇺🇸

AAI Clinic, Chapel Hill, North Carolina, United States

Lamotrigine Pregnancy Registry (LAM05)

First Posted Date
2010-02-08
Last Posted Date
2013-02-25
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
3416
Registration Number
NCT01064297

Birth Defects Associated With Exposure to Lamotrigine in Pregnancy (EUROCAT)

First Posted Date
2010-01-25
Last Posted Date
2014-10-01
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
1
Registration Number
NCT01055327

Bipolar Depression Before and After Lamotrigine Treatment

Phase 3
Completed
Conditions
Bipolar Depression
Interventions
Procedure: 1H-MR
First Posted Date
2010-01-05
Last Posted Date
2016-02-08
Lead Sponsor
Mayo Clinic
Target Recruit Count
72
Registration Number
NCT01042496
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

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