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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

Treatment of Alcohol Dependence and Comorbid Bipolar Disorder

Phase 4
Completed
Conditions
Depression
Mania
Psychosis
Bipolar Disorder
Alcohol Dependence
Interventions
Drug: Placebo
First Posted Date
2009-11-18
Last Posted Date
2019-01-09
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
43
Registration Number
NCT01015586
Locations
🇺🇸

Clinical Neuroscience Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, United States

Lamictal TM, Haloperidol Decanoate in Schizophrenia

Phase 4
Terminated
Conditions
Schizophrenia
Interventions
First Posted Date
2009-07-28
Last Posted Date
2009-07-28
Lead Sponsor
Central Mental Clinic for Outpatients of Baku City
Target Recruit Count
335
Registration Number
NCT00947375
Locations
🇦🇿

Central Mental Clinic for Outpatients of Baku City, Baku, Azerbaijan

Study of Lamotrigine 2×25 mg IR Tablets of Torrent Pharmaceuticals Limited, India and Lamictal® (Lamotrigine) 2×25 mg Tablets of GlaxoSmithKline, USA, in Healthy Human Adult Subjects, Under Fasting Conditions.

Phase 1
Completed
Conditions
Healthy
First Posted Date
2009-07-15
Last Posted Date
2017-10-25
Lead Sponsor
Torrent Pharmaceuticals Limited
Registration Number
NCT00939614
Locations
🇮🇳

Lotus Labs Pvt. Ltd., Bangalore, Karnataka, India

Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects, Under Fed Conditions

Phase 1
Completed
Conditions
Healthy
First Posted Date
2009-07-15
Last Posted Date
2017-10-25
Lead Sponsor
Torrent Pharmaceuticals Limited
Registration Number
NCT00939458
Locations
🇮🇳

Lotus Labs Pvt. Ltd., Bangalore, Karnataka, India

The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis

Phase 2
Conditions
Relapsing-Remitting Multiple Sclerosis
Interventions
First Posted Date
2009-06-10
Last Posted Date
2009-06-10
Lead Sponsor
Cantonal Hospital of St. Gallen
Target Recruit Count
88
Registration Number
NCT00917839
Locations
🇨🇭

Cantonal Hospital St. Gallen, St. Gallen, Switzerland

Cognitive Effects of Treatment of Interictal Discharges

Not Applicable
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2009-06-09
Last Posted Date
2018-10-03
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
31
Registration Number
NCT00916149
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia

Phase 2
Completed
Conditions
Trigeminal Neuralgia
Interventions
First Posted Date
2009-06-03
Last Posted Date
2010-06-29
Lead Sponsor
University of Malaya
Target Recruit Count
21
Registration Number
NCT00913107
Locations
🇲🇾

Dept. of OMOP, Faculty of Dentistry, University Malaya., Kuala Lumpur, Malaysia

🇲🇾

Dept. of Oral Medicine and Oral Pathology, Faculty of Dentistry, University Malaya., Kuala Lumpur, Malaysia

A Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects

Phase 1
Terminated
Conditions
Bipolar Disorder
Interventions
First Posted Date
2009-05-25
Last Posted Date
2017-07-21
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
12
Registration Number
NCT00907985
Locations
🇩🇪

GSK Investigational Site, Goettingen, Niedersachsen, Germany

Lamotrigine Augmentation in Resistant Depression

Not Applicable
Completed
Conditions
Unipolar Depression
Interventions
First Posted Date
2009-05-13
Last Posted Date
2009-05-13
Lead Sponsor
Louisiana State University Health Sciences Center in New Orleans
Target Recruit Count
138
Registration Number
NCT00901407
Locations
🇺🇸

LSUHSC- New Orleans, New Orleans, Louisiana, United States

Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

Phase 4
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2009-05-12
Last Posted Date
2009-05-12
Lead Sponsor
Korean Epilepsy Society
Target Recruit Count
121
Registration Number
NCT00896987
Locations
🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

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