Clinical Trials

Numerous clinical trials across phases 1 through 4 have evaluated lamotrigine in healthy volunteers and patient populations with neurological or psychiatric conditions, including focal epilepsy, bipolar disorder, Meniere disease, secondary progressive multiple sclerosis, and corticosteroid-induced memory impairment. Sponsored by pharmaceutical companies, academic institutions, and government entities, these studies encompass recruitment statuses ranging from active and completed to terminated or withdrawn. Specific protocol objectives across these investigations include assessing monotherapy efficacy in partial seizures and evaluating neurocognitive outcomes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06929273 RECRUITING
Bipolar Disorder Type I With Mania
Bristol-Myers Squibb
 2025-07-18 PHASE3
NCT06184581 RECRUITING
Bipolar II Disorder
University Hospital Bispebjerg and Frederiksberg
 2024-05-08 PHASE4
NCT07140913 RECRUITING
Mania; Bipolar Disorder
Bristol-Myers Squibb
 2025-10-08 PHASE3
NCT06729970 COMPLETED
Healthy Volunteers
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
 2024-12-26 PHASE1
NCT05881928 UNKNOWN
Epilepsy; Lamotrigine; Sodium Valproate Adverse Reaction
Assiut University
 2024-07-29 PHASE4
NCT05420350 UNKNOWN
Meniere Disease; Ménière's Vertigo; Vertigo, Intermittent; Vertigo, Aural
Dent Neuroscience Research Center
 2020-12-16 PHASE2
NCT03689114 COMPLETED
Epilepsies, Partial
Mario Negri Institute for Pharmacological Research
 2021-05-10 PHASE4
NCT05639257 UNKNOWN
Non-Dystrophic Myotonia
Grete Andersen, MD
 2022-12-05
NCT04770493 COMPLETED
Alcohol Use Disorder
Brown University
 2022-01-24 PHASE2
NCT06049095 Recruiting
Healthy
Latigo Biotherapeutics
 2023-10-17 Phase 1
NCT05748236 UNKNOWN
Focal Epilepsy
Dhaka Medical College
 2022-11-01 PHASE4
NCT05017155 UNKNOWN
Non-Dystrophic Myotonia
University College, London
 2021-08-12 PHASE3
NCT04939675 UNKNOWN
Epilepsy
National Taiwan University Hospital
 2021-07-01
NCT05697614 UNKNOWN
Drug Resistant Epilepsy
Dr Cipto Mangunkusumo General Hospital
 2023-03-01 PHASE4
NCT06199791 COMPLETED
Fasting
Desitin Arzneimittel GmbH
 2023-04-03 PHASE1
NCT03504501 TERMINATED
Impaired Synaptic Plasticity; Impaired Cognition
Technical University of Munich
 2019-03-22 PHASE2
NCT04602221 COMPLETED
Healthy
Boehringer Ingelheim
 2020-12-01 PHASE1
NCT03831854 COMPLETED
Reducing Psychological Side Effects of Ketamine
The Cleveland Clinic
 2019-01-24 PHASE3
NCT04156035 COMPLETED
Emotions
Charite University, Berlin, Germany
 2020-03-10
NCT05420350 Recruiting
Meniere Disease|Ménière''s Vertigo|Vertigo Intermittent|Vertigo Aural
Dent Neuroscience Research Center|Cures Within Reach|Dent Family Foundation
 2020-12-16 Phase 2
NCT04938856 COMPLETED
Bioequivalence
University of Karachi
 2020-09-04 PHASE1
NCT04523935 COMPLETED
Cerebral Palsy; Excessive Crying; Pain
Sathbhavana Brain Clinic
 2005-12-07 PHASE4
NCT02256124 TERMINATED
Neurofibromatosis Type 1
Erasmus Medical Center
 2014-10 PHASE2; PHASE3
NCT02708849 TERMINATED
Mental Disorders
Yale University
 2015-06 PHASE1
NCT04015687 COMPLETED
Healthy Participants
Agios Pharmaceuticals, Inc.
 2019-07-15 PHASE1
NCT03116828 COMPLETED
Epilepsy With Partial On-set Seizures
Sumitomo Pharma America, Inc.
 2017-07-07 PHASE4
NCT03695094 COMPLETED
Epilepsy
UCB Biopharma S.P.R.L.
 2018-09-18 PHASE1
NCT03898011 COMPLETED
Healthy Adults
Pharmtechnology LLC
 2019-03-23 PHASE1
NCT03161509 TERMINATED
Bariatric Surgery Candidate
Rambam Health Care Campus
 2017-07-01 PHASE4
NCT04396938 COMPLETED
Healthy
University of Oxford
 2017-05-10
NCT02707965 COMPLETED
Epilepsy
Food and Drug Administration (FDA)
 2017-06-08 PHASE1
NCT03220256 UNKNOWN
Lamotrigine Allergy
Seoul National University Hospital
 2016-08-02 PHASE2
NCT02081287 COMPLETED
Bipolar Disorder; Manic Depression
San Diego Veterans Healthcare System
 2014-05 PHASE1
NCT02389712 TERMINATED
Bipolar Disorder
Mayo Clinic
 2015-03 PHASE4
NCT05145608 COMPLETED
Bioequivalence
Alembic Pharmaceuticals Ltd.
 2018-01-10 PHASE1
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT01880957 COMPLETED
Bipolar Disorder; Bipolar Depression; Unipolar Depression
Stony Brook University
 2011-11-08
NCT02556060 COMPLETED
Addiction
Taipei City Hospital
 2015-09 PHASE2; PHASE3
NCT02158585 COMPLETED
Meniere's Disease; Ménière's Vertigo; Vertigo, Intermittent; Vertigo, Aural
Dent Neuroscience Research Center
 2014-06 PHASE2
NCT01588457 COMPLETED
Bipolar I Disorder; Bipolar II Disorder
The University of Texas Health Science Center at San Antonio
 2011-06 PHASE4
NCT01733394 COMPLETED
Epilepsy
University of Cincinnati
 2012-12-12 PHASE4
NCT02821338 COMPLETED
Healthy
Food and Drug Administration (FDA)
 2016-06 PHASE1
NCT00571246 WITHDRAWN
Alcohol Dependence; Post Traumatic Stress Disorder
Yale University
 2012-06 PHASE3
NCT01463111 COMPLETED
Bipolar Disorder
Emory University
 2011-05
NCT02404168 COMPLETED
Epilepsy
University of Maryland, Baltimore
 2015-07-07 PHASE4
NCT01602510 COMPLETED
Bipolar Disorder
GlaxoSmithKline
 2012-08 PHASE3
NCT02513654 COMPLETED
Bipolar Disorder
GlaxoSmithKline
 2015-09-06 PHASE1
NCT01939561 COMPLETED
Dystrophia Myotonica Type 1; Myotonia Congenita; Paramyotonia Congenita; Hyperkalemic Periodic Paralysis; Potassium-Aggravated Myotonia
Grete Andersen, MD
 2013-11 PHASE3
NCT01891890 TERMINATED
Epilepsy, Partial; Epilepsy, Localization Related
Emory University
 2013-08 PHASE3
NCT01713777 COMPLETED
Epilepsy
University of Cincinnati
 2013-04 PHASE4
NCT01142310 COMPLETED
Memory Impairment
University of Texas Southwestern Medical Center
 2010-06 PHASE4
NCT00475137 COMPLETED
Bipolar II Disorder, Most Recent Episode Major Depressive
University of British Columbia
 2007-12 PHASE2
NCT02100644 COMPLETED
Epilepsy
GlaxoSmithKline
 2014-04-12 PHASE4
NCT00926835 TERMINATED
Major Depressive Disorder
Ministry of Health & Welfare, Korea
 2009-05 PHASE4
NCT02303106 COMPLETED
Healthy
Per Damkier
 2014-11 PHASE4
NCT01042496 COMPLETED
Bipolar Depression
Mayo Clinic
 2009-12 PHASE3
NCT02064465 COMPLETED
Epilepsy
GlaxoSmithKline
 2014-03-15 PHASE1
NCT01674010 TERMINATED
Bipolar 1 Disorder
OPKO Health, Inc.
 2012-08 PHASE2
NCT01015586 COMPLETED
Alcohol Dependence; Bipolar Disorder; Depression; Mania; Psychosis
Medical University of South Carolina
 2010-02 PHASE4
NCT01431976 COMPLETED
Epilepsy
GlaxoSmithKline
 2011-09 PHASE3
NCT01995825 COMPLETED
Epilepsy
University of Maryland, Baltimore
 2012-05 PHASE4
NCT01879423 COMPLETED
Epilepsy
GlaxoSmithKline
 2013-04-28 PHASE1
NCT00531518 COMPLETED
Schizophrenia; Bipolar Disorder; Depression; Psychotic Disorders
MaineHealth
 2007-10
NCT01431963 COMPLETED
Epilepsy
GlaxoSmithKline
 2011-09 PHASE3
NCT00088452 COMPLETED
Childhood Absence Epilepsy; Petit Mal Epilepsy; Epilepsy; Seizures
Children's Hospital Medical Center, Cincinnati
 2004-07 PHASE3
NCT00916149 COMPLETED
Epilepsy
Massachusetts General Hospital
 2007-01
NCT01618825 COMPLETED
Fed
IPCA Laboratories Ltd.
 2012-03 PHASE1
NCT01618799 COMPLETED
Fasting State
IPCA Laboratories Ltd.
 2012-03 PHASE1
NCT00807989 COMPLETED
Epilepsy
Yonsei University
 2008-03 PHASE4
NCT00720473 COMPLETED
Bipolar Depression
Mclean Hospital
 2006-04
NCT01357902 COMPLETED
Epilepsy
GlaxoSmithKline
 2011-04-18 PHASE1
NCT00789113 COMPLETED
Epilepsy; Seizures; Bipolar Disorder; Bipolar Depression
University of Minnesota
 2008-11 PHASE1; PHASE2
NCT00917839 UNKNOWN
Relapsing-Remitting Multiple Sclerosis
Cantonal Hospital of St. Gallen
 2009-06 PHASE2
NCT00305578 COMPLETED
Bipolar Depression
Indiana University
 2005-08 PHASE4
NCT00566020 COMPLETED
Bipolar Disorder
GlaxoSmithKline
 2008-05 PHASE3
NCT01888757 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2010-09 PHASE1
NCT01888250 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2010-08 PHASE1
NCT01888731 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2010-08 PHASE1
NCT01888263 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2010-08 PHASE1
NCT00516139 COMPLETED
Epilepsy
GlaxoSmithKline
 2007-08 PHASE3
NCT00438451 COMPLETED
Focal Epilepsy
Johannes Gutenberg University Mainz
 2007-01 PHASE4
NCT00907985 TERMINATED
Bipolar Disorder
GlaxoSmithKline
 2009-05-15 PHASE1
NCT00621842 COMPLETED
Bipolar Disorder; Depression, Bipolar
University Hospitals Cleveland Medical Center
 2008-01 PHASE3
NCT00280293 COMPLETED
Bipolar Disorder; Cocaine Dependence
University of Texas Southwestern Medical Center
 2006-03 PHASE4
NCT00280059 COMPLETED
Epilepsy, Partial
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2006-08 PHASE3
NCT00550407 COMPLETED
Bipolar Disorder
GlaxoSmithKline
 2007-11 PHASE3
NCT00292461 COMPLETED
Epilepsy
Eisai Inc.
 2006-03 PHASE3
NCT00513019 COMPLETED
Neurotic Excoriation; Pathologic Skin Picking; Psychogenic Excoriation; Dermatillomania
University of Chicago
 2007-08 PHASE2
NCT00277212 COMPLETED
Bipolar Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2005-12-01 PHASE4
NCT01864551 COMPLETED
Bipolar Disorder
Tri-Service General Hospital (TSGH)
 2008-08 PHASE4
NCT00855738 COMPLETED
Focal Epilepsy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2007-05 PHASE4
NCT00183469 COMPLETED
Bipolar Disorder; Depression
The University of Texas Health Science Center at San Antonio
 2004-12 PHASE4
NCT00277641 COMPLETED
Binge Eating Disorder; Obesity
Lindner Center of HOPE
 2006-03 PHASE3
NCT00257855 COMPLETED
Secondary Progressive Multiple Sclerosis
University College London Hospitals
 2005-11 PHASE2
NCT00483548 COMPLETED
Bipolar Disorder; Depression, Bipolar
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2007-10 PHASE3
NCT00896987 COMPLETED
Epilepsy
Korean Epilepsy Society
 2006-05 PHASE4
NCT00355082 COMPLETED
Epilepsy, Partial
GlaxoSmithKline
 2006-05 PHASE3
NCT00618241 COMPLETED
HIV Infection
Radboud University Medical Center
 2008-02 PHASE1
NCT00627575 COMPLETED
Epilepsy
GlaxoSmithKline
 2008-02-04 PHASE1
NCT01607086 COMPLETED
Mental Disorders
GlaxoSmithKline
 2008-07-11 PHASE1
NCT00419003 COMPLETED
Major Depression
Baylor College of Medicine
 2006-12 PHASE4
NCT00104416 COMPLETED
Epilepsy, Tonic-Clonic
GlaxoSmithKline
 2004-12 PHASE3
NCT00243152 COMPLETED
Facial Neuropathy
Pain and Analgesia Imaging and Neuroscience Group
 2005-10
NCT00242606 COMPLETED
Epilepsy
Philipps University Marburg
 2005-03 PHASE3
NCT00488566 COMPLETED
Bipolar Disorder
Biogen
 2007-05-31 PHASE1
NCT00605371 COMPLETED
Epilepsy
GlaxoSmithKline
 2008-01-15 PHASE1
NCT00913107 COMPLETED
Trigeminal Neuralgia
University of Malaya
 2007-09 PHASE2; PHASE3
NCT00181844 COMPLETED
Bipolar Disorder; Mania
Massachusetts General Hospital
 2005-01 PHASE4
NCT00579982 COMPLETED
Mood Disorders
GlaxoSmithKline
 2008-01 PHASE3
NCT00176228 COMPLETED
Bipolar Disorder
University of Illinois at Chicago
 2004-02 PHASE2
NCT00223509 COMPLETED
Bipolar Disorder
The University of Texas Health Science Center at San Antonio
 2005-08 PHASE4
NCT00074776 COMPLETED
Bipolar Disorder
Stanford University
 2003-05 PHASE3
NCT00634062 COMPLETED
Borderline Personality Disorder
Mclean Hospital
 2004-12 PHASE4
NCT00206778 COMPLETED
Mixed Mania Bipolar Disorder
Beth Israel Medical Center
 2003-07 PHASE2
NCT00063362 TERMINATED
Bipolar Disorder
University Hospitals Cleveland Medical Center
 2002-02 PHASE3
NCT00449774 COMPLETED
Mental Disorders
GlaxoSmithKline
 2007-05-07 PHASE1
NCT00221975 COMPLETED
Bipolar Disorder
University Hospitals Cleveland Medical Center
 2002-07 PHASE3
NCT00412191 COMPLETED
Epilepsy
GlaxoSmithKline
 2007-02-06 PHASE1
NCT00321516 COMPLETED
Bipolar Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2006-07 PHASE1
NCT00360126 COMPLETED
Bipolar Disorder
GlaxoSmithKline
 2005-10 PHASE4
NCT00284791 TERMINATED
Adolescent Depression
MaineHealth
 2006-01
NCT00410371 COMPLETED
Mental Disorders
GlaxoSmithKline
 2006-12-28 PHASE1
NCT02283801 COMPLETED
Epilepsy
Bial - Portela C S.A.
 2006-11 PHASE1
NCT00224510 COMPLETED
Bipolar Disorder; Bipolar Depression
GlaxoSmithKline
 2002-08 PHASE3
NCT00901407 COMPLETED
Unipolar Depression
Louisiana State University Health Sciences Center in New Orleans
 2003-12
NCT00044278 COMPLETED
Epilepsy
GlaxoSmithKline
 2000-09 PHASE2
NCT00264615 COMPLETED
Epilepsy
GlaxoSmithKline
 2005-10 PHASE3
NCT00203229 COMPLETED
Trigeminal Neuralgia
Thomas Jefferson University
 2003-06
NCT00068445 COMPLETED
Neurotoxicity; Pain; Unspecified Adult Solid Tumor, Protocol Specific
Alliance for Clinical Trials in Oncology
 2004-02 PHASE3
NCT00144872 COMPLETED
Seizure, Absence
GlaxoSmithKline
 2004-11-01 PHASE1
NCT00652171 COMPLETED
Depression
Institute of Social Security of the Civil Servants of Minas Gerais
 2004-01 PHASE3
NCT00223262 COMPLETED
Memory Impairment Due to Corticosteroid Use; Hypomania Due to Corticosteroid Use; Hippocampal Atrophy Due to Corticosteroid
University of Texas Southwestern Medical Center
 2002-08 PHASE4
NCT00056277 COMPLETED
Bipolar Disorder
GlaxoSmithKline
 2003-02-27 PHASE3
NCT02989727 COMPLETED
Depression; Bipolar Disorder; Bipolar Depression; Melancholia; Lamotrigine
University of Saskatchewan
 2003-11 PHASE4
NCT00274677 COMPLETED
Bipolar Disorder
GlaxoSmithKline
 2003-11 PHASE3
NCT00086593 COMPLETED
Schizophrenia
GlaxoSmithKline
 2004-05 PHASE3
NCT00067938 COMPLETED
Bipolar Disorder
GlaxoSmithKline
 2003-08 PHASE4
NCT00650208 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2004-07 PHASE1
NCT00647751 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2004-08 PHASE1
NCT00043901 COMPLETED
Epilepsy, Tonic-Clonic
GlaxoSmithKline
 2000-12-01 PHASE4
NCT00043875 COMPLETED
Epilepsy
GlaxoSmithKline
 2000-05 PHASE2
NCT01131949 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2003-01 PHASE1
NCT01131975 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2003-01 PHASE1
NCT00043914 COMPLETED
Epilepsy
GlaxoSmithKline
 2002-01-14 PHASE4
NCT01513720 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2002-12 PHASE1
NCT01513681 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2002-11 PHASE1
NCT00838136 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2002-02 PHASE1
NCT00838279 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2002-02 PHASE1
NCT00834561 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2002-01 PHASE1
NCT00835263 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2002-01 PHASE1
NCT00015106 COMPLETED
Cocaine-Related Disorders
National Institute on Drug Abuse (NIDA)
 1997-11 PHASE2
NCT00000192 WITHDRAWN
Opioid-Related Disorders
Yale University
 1993-01 PHASE2
NCT00137709 UNKNOWN
Epilepsy
Chinese University of Hong Kong
 2004-11 PHASE4
NCT00269594 COMPLETED
Neurotic Disorders; Obsessive-Compulsive Disorder
University of Minnesota
 2006-01 PHASE2
NCT00485771 COMPLETED
Bipolar Disorder
Eli Lilly and Company
 2003-11 PHASE4
NCT00226135 COMPLETED
Bipolar Disorder
University of Aarhus
 2001-03 PHASE3
NCT00208520 UNKNOWN
Adults With Tonic Clonic Seizures and/or Partial Seizures
Dutch Epilepsy Clinics Foundation
 2003-07
NCT00939458 COMPLETED
Healthy
Torrent Pharmaceuticals Limited
 PHASE1
NCT00939614 COMPLETED
Healthy
Torrent Pharmaceuticals Limited
 PHASE1
NCT00188643 COMPLETED
Bipolar Disorder
University Health Network, Toronto
 2002-01 PHASE4
NCT00001482 COMPLETED
Anxiety Disorder; Mood Disorder; Psychotic Disorder
National Institute of Mental Health (NIMH)
 1995-05 PHASE2
NCT00153244 COMPLETED
Bronchial Asthma
Centre of Chinese Medicine, Georgia
 2002-08 PHASE4
NCT00007670 COMPLETED
Seizures
US Department of Veterans Affairs
 1998-01 PHASE3
NCT00266149 TERMINATED
Epilepsy
University of Aarhus
 2003-06 PHASE3
NCT00177567 COMPLETED
Bipolar Disorder
University of Pittsburgh
 2001-07 PHASE4
NCT00071747 COMPLETED
Schizophrenia
GlaxoSmithKline
 2003-08 PHASE3
NCT00012558 COMPLETED
Bipolar Disorder
National Institute of Mental Health (NIMH)
 1998-09

(data from https://clinicaltrials.gov, updated on 2026-08-25)

Check the Lamotrigine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lamotrigine functions as a voltage-gated sodium channel blocker that also inhibits the synaptosomal reuptake of 5-hydroxytryptamine, noradrenaline, and dopamine. By stabilizing presynaptic neuronal membranes and suppressing the excessive release of excitatory neurotransmitters, this compound mitigates aberrant repetitive neuronal firing, demonstrating therapeutic relevance in the management of partial epilepsy and bipolar disorder.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.