Lamotrigine has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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lamotrigine studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
EPI40048 IV GlaxoSmithKline International Lamotrigine Pregnancy Registry
LAM40013 IV A Multicenter, Open Label Conversion of Valproate Monotherapy to Lamotrigine Monotherapy in Patients with Epilepsy
Lamotrigine Suicidality Pooled Analysis IV Analysis of data in lamotrigine clinical trials for suicidality
100790 (LAM40119) IV An Open, Randomized, Multicenter Comparative Trial of Lamotrigine and Carbamazepine as Initial Monotherapy in Previously Untreated Epilepsies
EPIP090 IV Frequency of Severe Cutaneous Adverse Reactions in Population Exposed to Antiepileptic Drugs
LAM 40005 IV Open study evaluating lamotrigine efficacy and safety in add-on treatment and consecutive monotherapy in patients with carbamazepine- or valproate- resistant epilepsy.
LAM30006 IV An Open-label, Multi-Center, Cross-Sectional Observational Study Comparing the Prevalence of Metabolic and Menstrual Disturbances in Women with Epilepsy on Lamotrigine or Valproate Monotherapy
LAM30007 IV Open-Label, Multicenter, Randomized Trial to Evaluate the Development of Components of Polycystic Ovary Syndrome (PCOS) in Female Subjects Initiating Lamotrigine or Valproate Either as Monotherapy for Newly Diagnosed Epilepsy or as Adjunctive Therapy for Inadequately Controlled Epilepsy
LAM40006 IV A Multicenter, Double-Blind, Randomized, Placebo-Controlled Evaluation of LAMICTAL (lamotrigine) in Adult Subjects with HIV-Associated Peripheral Neuropathy
LAM40089 IV An International, Multicenter Double-Blind Randomised Comparative Trial of Lamotrigine and Slow Release Carbamazepine in Elderly Subjects with Newly Diagnosed Epilepsy.
LAM40090 IV Valproate monotherapy conversion to lamotrigine monotherapy – efficacy assessment in open-label, prospective 32-week study in children 2 – 12 aged with epilepsy. The LAM40090 Study Group
LAM40091 IV Lamictal in Combination with Newer and Older Antiepileptic Drugs and as Monotherapy: A Practical Clinical Assessment of Tolerability and Clinical Effectiveness (The TARGET Study: Trial to Assess and Refine Global Epilepsy Treatment)
LAM40096 IV An open study comparing lamotrigine efficacy and safety in add-on treatment with carbamazepine or valproate and consecutive monotherapy in patients with resistant epilepsy
LAM40097 (double blind) IV A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic Seizures [Data From the Double-Blind Phase]
LAM40097 (open label) IV A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Evaluation of Lamotrigine Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures [Data from the Open-label Continuation Phase]
LAM40099 IV An open, randomised, multicentre comparative trial of lamotrigine dispersible tablets and sodium-valproate-slow release as monotherapy in patients 60 years and older.
LAM40112 IV Double-blind Randomized Trial of Cognitive Effects of LAMICTAL (lamotrigine) versus Topiramate in Epilepsy
LAM40117 IV A Multicenter, Open-Label, Pilot Study of Lamotrigine as Adjunctive Therapy and Monotherapy in Patients with Epilepsy and Comorbid Depressive Symptoms
LAM40120 IV LAMOTRIGINE (Lamictal®) Treatment in adults with Attention Deficit Hyperactivity Disorder (ADHD), A pilot study.
LAM40124 IV An Assessment of Behavioral Changes Associated with Lamotrigine and Levetiracetam in Patients with Epilepsy
MY-LAM-401 (LAM40123) IV An open label, non-comparative, multicentre study to evaluate effectiveness and tolerability of Lamictal as first line monotherapy at the dose ranging from 25-200mg for 24 weeks in a flexible dosing regimen in senior/elderly newly diagnosed epileptic Malaysian patients having CT Scan abnormalities.
SCA104753 IV An Open-Label Extension Study to Assess the Safety of Lamotrigine in Subjects with Bipolar Disorder, who are in remission following a manic/hypomanic index episode or a depressive index episode.
SCA40917 IV An open-label study of tolerability, clinical response, and satisfaction in adult and adolescent (13-17 years) bipolar I subjects optimizing initiation of therapy using administration of dermatological precautions and LAMICTAL titration packs
SCAA4001 IV A Double-blind, Double-dummy, Parallel-group Comparison of Lamotrigine and Divalproex Sodium Initial Monotherapy in Patients with Epilepsy
US50 IV Repeated bioequivalence study of US 25 mg Lamictal® compressed tablets, US 5 mg Lamictal® dispersible/chewable tablets and UK 5 mg Lamictal® dispersible/chewable tablets in healthy adult male volunteers.
WEUKSTV2169/EPI40486 IV Case control study of lamotrigine and orofacial clefts in the EUROCAT network
105-030/031 III A Multicenter, Double-Blind, Active-Control Evaluation of The Efficacy and Safety of Lamotrigine Monotherapy in Patients With Partial Seizures
105-040 III A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients
105-044 III An Evaluation of Lamotrigine Monotherapy for the Treatment of Newly–Diagnosed Typical Absence Seizures in Children and Adolescents
105-052 III Single-dose pharmacokinetics of lamotrigine in pediatric patients with epilepsy in the absence of other antiepileptic drugs
105-123 III Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (severe generalised epilepsy of childhood onset). A multicentre, double-blind, placebo-controlled, parallel group study.
105-124-C93 III A Multicentre Double-Blind Randomised Comparative Trial of Lamotrigine and Carbamazepine in Elderly Patients with Newly Diagnosed Epilepsy
105-136 III Open Randomised Comparison of Lamotrigine with Carbamazepine as Monotherapy in Patients with Partial Seizures
105-511-L93 (LAM30043) III Long term safety of lamotrigine alone or in combination with other anti-epileptic therapy
H34-049-C87/H34-089-C88 III A Multicentre, Double Blind Comparison of the Efficacy and Safety of Lamotrigine and Carbamazepine Monotherapy in Patients with Newly Diagnosed Epilepsy
H34-074-C87 III A multicenter, double-blind comparison of the efficacy and safety of lamotrigine and phenytoin monotherapy in patients with newly diagnosed epilepsy.
LAM100118 III An Open-label Evaluation of LAMICTAL (lamotrigine, LTG) Monotherapy for the Treatment of Newly-diagnosed Typical Absence Seizures in Children and Adolescents
LAM20006 III A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics, and Efficacy of lamotrigine in Pediatric Age Subjects (1-24 months)
LAM-40012 III Lamotrigine versus Carbamazepine or Valproic Acid in Newly Diagnosed Focal and Generalized Epilepsies in Adolescents and Adults.
LAMT07 III An open, multicentre study to evaluate the efficacy and safety of lamotrigine as add-on therapy in patients with myoclonic seizures and syndromes.
LTG9603 III Use of Lamotrigine Adjunctive Therapy in Patients With Mental Retardation and Epilepsy: A Multicentre, Double-Blind, Placebo-Controlled Study with Evaluation of Behavioural Effects.
NPP30004 III A Multicenter, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of Lamotrigine 200mg/day, 300mg/day, and 400mg/day Compared with Placebo in Subjects with Painful Diabetic Neuropathy
NPP30005 III A Multicenter, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of Lamotrigine 200mg/day, 300mg/day, and 400mg/day Compared with Placebo in Subjects with Painful Diabetic Neuropathy
NPP30006 III An Open-Label Study to Evaluate the Safety of Lamotrigine in Subjects with Painful Diabetic Neuropathy
NPP30010 III A multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of lamotrigine in subjects with neuropathic pain and inadequate pain relief with gabapentin, tricyclic antidepressants or non-narcotic analgesics
P42-05 III A Multicenter, Placebo-Controlled, Parallel-Design, Dose-Response Evaluation of the Safety and Efficacy of Lamotrigine as Add-On Therapy in Epileptic Outpatients with Partial Seizures
P42-06 III A Multicenter, Double-Blind, Placebo-Controlled, Add-On, Crossover Study of Lamotrigine in Epileptic Outpatients with Partial Seizures
P42-16 III A Multicenter, Placebo-Controlled Parallel-Design, Phase III Evaluation of the Safety of Lamotrigine (LAMICTAL) as Add-On Therapy in Outpatients with Partial Seizures
SCA100223 III A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Major Depression in Patients with Type II Bipolar Disorder
SCA101464 III A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia
SCA101469 III An Open-Label, Prospective Study to Assess the Efficacy, Safety and Tolerability of 36 weeks Lamotrigine in the Prevention of Mood Episodes in Subjects with Bipolar Disorder, who are in remission following a manic/hypomanic index episode or a depressive index episode.
SCA30905 III A Multicentre, Double-Blind, Randomised, Fixed-Dose Evaluation of the Safety and Efficacy of Lamotrigine (Lamictal®) Compared to Placebo as Add-on Therapy to Lithium in the Treatment of Bipolar Depression followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Subjects With Bipolar Disorder.
SCA30923 III An open, prospective study of the effectiveness of lamotrigine in the prevention of recurrence in bipolar affective disorder
SCA30924 III A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Bipolar Disorder Patients Currently Experiencing a Major Depressive Episode
SCA30926 III A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel Group Evaluation of the Efficacy of a Flexible Dose of Lamotrigine versus Placebo as Add-on Therapy in Schizophrenia
SCA40910 III A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose Evaluation of the Safety, Efficacy, and Tolerability of LAMICTAL (Lamotrigine) in the Treatment of a Major Depressive Episode in Patients with Type I Bipolar Disorder
SCAB3001 III Open Randomized Comparison of Add-on Lamotrigine or Valproate/Carbamazepine Withdrawing to Monotherapy in Patients With Treatment Resistant Epilepsy
SCAB4007 (LAM-04-97) III An Open Randomised Comparison of Cognitive and Electrophysiological effects of Lamictal (LTG) or Slow Release Carbamazepine (CBZ) Monotherapy in Newly Diagnosed Patients with Epilepsy
105-601 II An Open, Multicenter 48-Week Evaluation of LAMICTAL (lamotrigine) for Bipolar Disorder in Adult Patients
H34-035-C86 II A Multicentre Randomised Double-Blind Placebo Controlled Crossover Trial of Lamotrigine (LTG) as Add-On Therapy in Treatment-Resistant Epilepsy: Australia
LAM20005 II Pharmacokinetics and safety of lamotrigine in young epileptic children
LAM20007 II An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and in LAMICTAL-naive Subjects (1-24 months of age)
SCA20022 II A Randomized, Multicenter, Double–Blind, Placebo–Controlled, Fixed–Dose, 7–Week Evaluation of the Efficacy and Safety of Lamotrigine in Patients with Major Depression
SCA20025 II A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose 7-Week Evaluation of the Efficacy and Safety of Lamotrigine in Treatment of a Major Depressive Episode in Unipolar Depressed Patients
SCAA2008 II A 3 Week Multicenter, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of LAMICTAL (lamotrigine) Compared to Placebo in the Treatment of An Acute Manic or Mixed Episode in Patients who have Bipolar Disorder
SCAA2010 II A Multicenter, Double–Blind, Placebo–Controlled, Flexible Dose (100–400mg) 10 Week Evaluation Of the Safety and Efficacy of LAMICTAL (Lamotrigine) in the Treatment of a Major Depressive Episode in Patients with Bipolar Disorder
SCAA2011 (105-613) II SCAA2011 (105-613): An Eight Week, Multicenter, Double-Blind, Randomized, Fixed-Dose Evaluation of the Efficacy and Safety of Lamotrigine (200mg/day), Desipramine (200mg/day), and Placebo in Outpatients with Unipolar Depression
SCAA2012 II A Multicenter, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Evaluation of the Safety and Efficacy of Lamotrigine in the Long-Term Prevention of Mood Episodes in Patients with Bipolar Disorder with Rapid Cycling
SCAA2014 II SCAA2014: A 52 Week, Open, Multicenter, Flexible-Dose Continuation Study of LAMICTAL (lamotrigine) in Patients with Bipolar Disorder Who Have Completed Protocol SCAA2010
SCAB2001 II A Multicenter, Double–Blind, Placebo–Controlled, Fixed Dose (50 or 200mg per day) 7 Week Evaluation of the Safety and Efficacy of LAMICTAL (Lamotrigine) in the Treatment of a Major Depressive Episode in Patients Suffering From Bipolar Disorder
SCAB2002 II A 52 Week, Open-label, Multicenter, Flexible-Dose Continuation Study of LAMICTAL (Lamotrigine) in Patients with Bipolar Disorder
SCAB2003 (105-605) II A Multicenter, Double-blind, Placebo-controlled, Randomized, Fixed-dose Evaluation of the Safety and Efficacy of Lamotrigine in the Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Subjects with Bipolar I Disorder
SCAB2005 II A Multicenter, Double-Blind, Placebo-Controlled, Flexible-Dose Evaluation of the Safety and Efficacy of Lamotrigine in the Long Term Treatment of Subjects who have Bipolar Disorder with Rapid Cycling
SCAB2006 II A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Flexible-Dose Evaluation of the Safety and Efficacy of Lamotrigine in the Long-Term Prevention of Relapse and Recurrence of Mania and/or Depression in Subjects with Bipolar I Disorder
SCAB2009 II A Six-Week, Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose Evaluation of the Safety and Efficacy of Lamotrigine Compared to Placebo and Lithium in the Treatment of an Acute Manic Episode in Patients who have Bipolar Disorder
UK25 II Lamotrigine: a single-blind dose-ranging study in patients with epilepsy.
51 I Repeated bioequivalence study of US 100 mg Lamictal® compressed tablets, US 100 mg Lamictal® dispersible/chewable tablets and UK 100 mg Lamictal® dispersible/chewable tablets in healthy adult male volunteers.
08-01 (UK08) I The Influence of Acetaminophen on the Pharmacokinetics of Lamotrigine
105-039 I A bioequivalence study of the US 25 mg LAMICTAL® compressed tablets, UK 25 mg LAMICTAL® dispersible/chewable tablets, and US 25 mg LAMICTAL® dispersible/chewable caplets in normal volunteers.
430C/83/6 I The single dose kinetics in man of 120mg of BW430C, a potential anticonvulsant
999910/124 I A double blind, randomised, cross-over study to assess lamotrigine modulation of ketamine effects using functional magnetic resonance imaging in healthy male volunteers
BDPA/88/001 (UK20) I The Disposition, Metabolism and Pharmacokinetics of 14C-Lamotrigine After Single Oral Administration of 240mg (15µCi) to Six Healthy Male Subjects
BDPS 89 0001 I The pharmacokinetics and bioequivalence of lamotrigine capsules and tablets, and effect of food on lamotrigine tablets
H34/064/V/87 (UK64) I The Pharmacokinetics and Bioequivalence of, and Effect of Food on, Lamotrigine Capsules and Tablets
H34/100/V/88 I The bioequivalence of lamotrigine tablets and syrup
H34/107-STW881 I The pharmacokinetics of lamotrigine in chronic renal failure: Influence of haemodialysis
H34/V/AFC/84/01 (UK13) I Pharmacokinetics of Lamotrigine After Oral and Intravenous Infusion Administration in Normal Volunteers
L105-122 I Report of a study to investigate the pharmacokinetic and pharmacodynamic interaction of lamotrigine (300 mg) and lorazepam (1 mg) in healthy volunteers.
L105-503 I Pharmacokinetics and tolerability of a single oral dose of lamotrigine in liver disease
LAM10004 I An open, randomised, parallel group study in healthy, young, male and female volunteers to evaluate the pharmacokinetic characteristics of single oral does of new LAMICTAL™ formulations.
LAM10005 I A two-part, open label study in healthy, male and female volunteers to evaluate the pharmacokinetic characteristics of single and repeat oral doses of various LAMICTAL™ prototype formulations.
LAM10007 I An open, randomised, study to investigate the gastrointestinal absorption (of 50 mg single doses) of lamotrigine from small bowel and ascending colon in healthy, male volunteers.
LAM10016 I An open-label, non-randomised, single sequence study to investigate the effects of the combined oral contraceptive pill on the pharmacokinetics of lamotrigine and the effects of lamotrigine on the pharmacokinetics of the combined oral contraceptive pill in healthy young female subjects
LAM10017 I An open-label study in healthy volunteers to evaluate the repeat dose pharmacokinetics, dose strength equivalence, dose proportionality, safety and tolerability of a prototype formulation and its relative bioavailability to lamotrigine immediate release tablets.
LBI108614 I An open-label, randomised, single-dose, parallel-group study to compare the pharmacokinetic characteristics, safety and tolerability of two formulations of lamotrigine in healthy subjects
LBI108617 I An open-label, randomised, single-dose, parallel-group study to demonstrate bioequivalence of two formulations and the effect of food and water on one formulation of lamotrigine in healthy male and female volunteers.
NAP107434 I A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg new chemical entity and 325 mg LAMICTAL™ on resting motor threshold in healthy male subjects.
PC 90-01 (UK9001) I Pharmacokinetics and Safety of Lamotrigine in Young Epileptic Children
RD 32/20370A H34(105)-121-V I Comparative bioavailability of 25mg and 100mg blackcurrant flavoured, dispersible lamotrigine tablets with 100mg lamotrigine capsules.
RD 32/20370B H34(105)-120-V I Comparative bioavailability of 5mg and 25mg black currant flavoured, dispersible lamotrigine tablets with 25mg lamotrigine capsules.
SCA 101963 I An open-label, two cohort study to investigate the potential pharmacokinetic interaction between lamotrigine and single doses of risperidone and quetiapine in healthy volunteers
SCA104648 I A study to evaluate the effect of repeat oral doses of lamotrigine on cardiac conduction as assessed by 12-Lead ECG as compared to placebo and single oral doses of moxifloxacin.
SCA10908 I A randomised, partially blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and olanzapine in healthy, non-smoking, male volunteers
SCA10910 I A randomised, partially blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and oxcarbazepine in healthy, non-smoking, male volunteers
SCAA1001 I A Randomized, Crossover Study to Evaluate the Pharmacokinetic Effect of Multiple Doses of Bupropion Hydrochloride (WELLBUTRIN SR) on a Single Oral Dose of Lamotrigine (LAMICTAL)
SCAB1001 I Report for a study to investigate whether multiple oral doses of lamotrigine affect the pharmacokinetic of multiple oral doses of Lithium in healthy volunteers.
THRS/91/0011 (UK19) I An Evaluation of the Bioavailability of 250 mg LAMICTAL® Tablets in Normal Volunteers
THRS/91/0023 (UK72) I Lamotrigine Pharmacokinetics in Healthy Elderly Volunteers
THRS/91/0025 (UK12) I The Pharmacokinetics of Lamotrigine (BW 430C) in Healthy Subjects with Unconjugated Hyperbilirubinemia (Gilbert’s Syndrome)
THRS/91/0045 (UK21) I Steady-State Pharmacokinetic Study of Lamictal® in Healthy Volunteers Receiving Chronic Doses of Valproic Acid
UK03 I Seven day administration of BW 430C (LAMICTAL) to normal volunteers- multiple dose pharmacokinetics and safety.
UK11 I Open one-week trial of lamotrigine as add-on therapy in patients with epilepsy.
UK113 I A comparison of the bioavailability of 100mg and 200mg lamotrigine (LAMICTAL) tablets in healthy volunteers.
UK120 I Comparative bioavailability of 5mg and 25mg blackcurrant flavoured, dispersible lamotrigine tablets with 25mg lamotrigine capsules.
US-01 I Acute Dose Safety and Pharmacokinetics Study of Lamotrigine and Placebo in Epileptic Patients
US14 I Chronic dose tolerance of lamotrigine (LAMICTAL®) and placebo in epileptic patients: A further evaluation.
US22 I An evaluation of the dose proportionality and bioequivalence of LAMICTAL® tablets in normal volunteers.
US47 (105-047) I A pilot bioequivalence study of US and UK manufactured 100 mg LAMICTAL® (lamotrigine) dispersible/chewable tablets in normal healthy volunteers.