MedPath

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

MExiletine Versus Lamotrigine in Non-Dystrophic Myotonias

Phase 3
Recruiting
Conditions
Non-Dystrophic Myotonia
Interventions
First Posted Date
2021-08-23
Last Posted Date
2022-11-02
Lead Sponsor
University College, London
Target Recruit Count
60
Registration Number
NCT05017155
Locations
🇬🇧

University College London Hospital, London, United Kingdom

Modification of Epilepsy Screen Questionnaire and Treatment Feasibility Evaluation

Not Applicable
Not yet recruiting
Conditions
Epilepsy
Interventions
First Posted Date
2021-06-25
Last Posted Date
2021-06-25
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
40
Registration Number
NCT04939675

Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions

Phase 1
Completed
Conditions
Bioequivalence
Interventions
First Posted Date
2021-06-24
Last Posted Date
2022-09-08
Lead Sponsor
University of Karachi
Target Recruit Count
26
Registration Number
NCT04938856
Locations
🇵🇰

Center for Bioequivalence Studies and clinical research, Karachi, Sindh, Pakistan

Enhancing the Effects of Alcohol Treatment With Lamotrigine

Phase 2
Completed
Conditions
Alcohol Use Disorder
Interventions
Drug: Placebo
First Posted Date
2021-02-25
Last Posted Date
2024-12-05
Lead Sponsor
Brown University
Target Recruit Count
44
Registration Number
NCT04770493
Locations
🇺🇸

Brown University Center for Alcohol and Addiction Studies, Providence, Rhode Island, United States

A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2020-10-26
Last Posted Date
2024-03-12
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
40
Registration Number
NCT04602221
Locations
🇺🇸

Hassman Research Institute, Marlton, New Jersey, United States

🇺🇸

Collaborative Neuroscience Research, LLC, Long Beach, California, United States

The Effect of a Single Dose of Lamotrigine on Brain Function in Healthy Volunteers

Not Applicable
Completed
Conditions
Healthy
Interventions
Drug: Placebos
First Posted Date
2020-05-21
Last Posted Date
2020-05-21
Lead Sponsor
University of Oxford
Target Recruit Count
36
Registration Number
NCT04396938
Locations
🇬🇧

University of Oxford, Oxford, Oxfordshire, United Kingdom

Ketamine-Induced Brain Changes and Their Modulation by Lamotrigine

Not Applicable
Completed
Conditions
Emotions
Interventions
Drug: Placebo Pretreatment
Drug: Placebo Infusion
First Posted Date
2019-11-07
Last Posted Date
2021-03-29
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
75
Registration Number
NCT04156035
Locations
🇩🇪

Medical School Berlin, Berlin, Germany

A Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adults

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2019-07-11
Last Posted Date
2019-10-14
Lead Sponsor
Agios Pharmaceuticals, Inc.
Target Recruit Count
22
Registration Number
NCT04015687
Locations
🇺🇸

Celerion, Inc, Tempe, Arizona, United States

A Bioequivalence Study of Two Formulations Lamotrigine 100 mg Tablets and Lamictal 100 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy Adults
Interventions
First Posted Date
2019-04-01
Last Posted Date
2019-06-06
Lead Sponsor
Pharmtechnology LLC
Target Recruit Count
28
Registration Number
NCT03898011
Locations
🇷🇺

State Autonomous Healthcare Facility of the Yaroslavl Region "Clinical Hospital No. 2", Yaroslavl, Yaroslavl Region, Russian Federation

Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine

Phase 3
Completed
Conditions
Reducing Psychological Side Effects of Ketamine
Interventions
First Posted Date
2019-02-06
Last Posted Date
2021-06-09
Lead Sponsor
The Cleveland Clinic
Target Recruit Count
46
Registration Number
NCT03831854
Locations
🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

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