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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

Lamotrigine Extended-Release Tablets 50 mg Under Fed 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
NCT01888757
Locations
🇮🇳

Bioserve Clinical Research Private Limited, Balanagar, Hyderabad, India

Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fasting Condition

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2013-06-27
Last Posted Date
2013-06-27
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
36
Registration Number
NCT01888250
Locations
🇮🇳

Bioserve Clinical Research Private Limited, Balanagar, Hyderabad, India

Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fed Condition

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2013-06-27
Last Posted Date
2013-06-27
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
32
Registration Number
NCT01888263
Locations
🇮🇳

Bioserve Clinical Research Private Limited, Balanagar, Hyderabad, India

PET and MRI Brain Imaging of Bipolar Disorder

Not Applicable
Completed
Conditions
Bipolar Disorder
Bipolar Depression
Unipolar Depression
Interventions
First Posted Date
2013-06-19
Last Posted Date
2022-07-20
Lead Sponsor
Stony Brook University
Target Recruit Count
76
Registration Number
NCT01880957
Locations
🇺🇸

Stony Brook University Hospital, Stony Brook, New York, United States

The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 5mg×5 Compared With Lamotrigine Compressed Tablet 25mg in Chinese Healthy Male Subjects

First Posted Date
2013-06-17
Last Posted Date
2017-06-01
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
24
Registration Number
NCT01879423
Locations
🇨🇳

GSK Investigational Site, Shanghai, China

Olanzapine Compared to Lamotrigine in the Prevention of Depressive Episode in the Patients With Bipolar Disorder

Phase 4
Completed
Conditions
Bipolar Disorder
Interventions
First Posted Date
2013-05-29
Last Posted Date
2013-05-29
Lead Sponsor
Tri-Service General Hospital
Target Recruit Count
60
Registration Number
NCT01864551
Locations
🇨🇳

Tri-Service General Hospital, Taipei, Taiwan

Special Drug Use Investigation for LAMICTAL® (Long Term)

Completed
Conditions
Epilepsy
Interventions
First Posted Date
2013-05-29
Last Posted Date
2016-11-09
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
850
Registration Number
NCT01863602

Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study)

First Posted Date
2012-11-27
Last Posted Date
2017-07-19
Lead Sponsor
University of Cincinnati
Target Recruit Count
54
Registration Number
NCT01733394
Locations
🇺🇸

University of Iowa, Iowa City, Iowa, United States

🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

Drake University, Des Moines, Iowa, United States

and more 5 locations

Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Chronic-Dose 4-Period Replicate Design

Phase 4
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2012-10-25
Last Posted Date
2015-10-01
Lead Sponsor
University of Cincinnati
Target Recruit Count
35
Registration Number
NCT01713777
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

Drake University, Des Moines, Iowa, United States

🇺🇸

Michel J. Berg, MD, Rochester, New York, United States

and more 5 locations

Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder

Phase 2
Terminated
Conditions
Bipolar 1 Disorder
Interventions
First Posted Date
2012-08-28
Last Posted Date
2019-10-21
Lead Sponsor
OPKO Health, Inc.
Target Recruit Count
309
Registration Number
NCT01674010
Locations
🇹🇷

Elan Investigational Site, Istanbul, Turkey

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