CLINICAL TRIALS PROFILE FOR LAMOTRIGINE

505(b)(2) Clinical Trials for lamotrigine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00214877 ↗	Methylene Blue for Cognitive Dysfunction in Bipolar Disorder	Completed	Stanley Medical Research Institute	Phase 3	2003-11-01	While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine. Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.
OTC	NCT00214877 ↗	Methylene Blue for Cognitive Dysfunction in Bipolar Disorder	Completed	Nova Scotia Health Authority	Phase 3	2003-11-01	While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine. Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.

All Clinical Trials for lamotrigine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006773 ↗	Bortezomib in Treating Patients With Recurrent Glioma	Terminated	National Cancer Institute (NCI)	Phase 1	2001-05-01	Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
NCT00007670 ↗	Does Gabapentin and Lamotriginel Have Significantly Fewer Side-Effects While Providing Equal or Better Seizure Control Than the Current Drug Choice, Carbamazepine, for the Treatment of Seizures in the Elderly.	Completed	Glaxo Wellcome	Phase 3	1998-01-01	New onset epilepsy in the elderly occurs in 45,000-50,000 elderly patients each year. These patients are especially vulnerable to side effects from medications because of changes caused by the aging process and the fact that these patients often have many common diseases for which they are already receiving medications for so that the likelihood of drug interactions is increased. Two new drugs, gabapentin and lamotrigine, have recently been approved by the FDA as antiepileptic drugs. These drugs have demonstrated efficacy in the treatment of partial onset seizures, the most common seizures in the elderly. These new compounds also have favorable side effect profiles and infrequent drug-drug interactions and, therefore, would be expected to be well-tolerated in the elderly.
NCT00001482 ↗	New Drugs in the Treatment of Mood Disorders	Completed	National Institute of Mental Health (NIMH)	Phase 2	1995-05-01	This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal) Monotherapy and Gabapentin (Neurontin) in patients with treatment resistant affective disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that of gabapentin (28%) or placebo (21%). In this study the placebo phase has been dropped so that we examine possible clinical and biological factors predictors of response. The drugs will be given in a randomized order for six weeks each and you will not know when you are on a given one. There will be a 2-4 week "washout" period between treatments. If you respond well to one of these treatments, a longer open continuation period will be offered at the end of this study. This would involve one or both drugs in combination. A variety of rating scales and brain imaging procedures will also be offered before and during each drug evaluation. Both lamotrigine and gabapentin are generally well tolerated. A serious potentially life threatening rash occurs in about 1/500 patients treated with lamotrigine, however. Common side effects are rash, dizziness, unsteadiness, double vision, blurred vision, nausea, vomiting, insomnia, sedation, and headache. These side effects are usually mild, and resolve with continued time on the drug or a decrease in dosage.
NCT00000192 ↗	Neurobiology of Opioid Dependence: 1 - 1	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1993-01-01	The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.
NCT00000192 ↗	Neurobiology of Opioid Dependence: 1 - 1	Withdrawn	Yale University	Phase 2	1993-01-01	The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.

Clinical Trial Conditions for lamotrigine

Condition Name

Condition Name for lamotrigine
Intervention	Trials
Bipolar Disorder	53
Epilepsy	44
Healthy	20
Bipolar Depression	11

Condition MeSH

Condition MeSH for lamotrigine
Intervention	Trials
Bipolar Disorder	64
Epilepsy	55
Disease	41
Depression	36

Clinical Trial Locations for lamotrigine

Trials by Country

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−

Trials by Country for lamotrigine
Location	Trials
United States	599
Germany	41
Canada	29
Italy	21
China	20

Trials by US State

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−

Trials by US State for lamotrigine
Location	Trials
Texas	37
Ohio	33
New York	32
California	25
Pennsylvania	24

Clinical Trial Progress for lamotrigine

Clinical Trial Phase

Clinical Trial Phase for lamotrigine
Clinical Trial Phase	Trials
Phase 4	59
Phase 3	47
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for lamotrigine
Clinical Trial Phase	Trials
Completed	157
Terminated	19
Recruiting	12

Clinical Trial Sponsors for lamotrigine

Sponsor Name

Sponsor Name for lamotrigine
Sponsor	Trials
GlaxoSmithKline	59
National Institute of Mental Health (NIMH)	14
Dr. Reddy's Laboratories Limited	8

Sponsor Type

Sponsor Type for lamotrigine
Sponsor	Trials
Other	190
Industry	118
NIH	23

Lamotrigine: Clinical Trials, Market Analysis, and Projections

Introduction to Lamotrigine

Lamotrigine, commonly known by the brand name Lamictal, is an antiepileptic medication that has been widely used for the treatment of epilepsy and bipolar disorder. Its efficacy and safety have been well-documented, and it is now being explored for other neurological conditions.

Ongoing Clinical Trials: Lamotrigine in Dementia with Lewy Bodies (DLB)

A significant ongoing clinical trial is investigating the efficacy and safety of lamotrigine in patients with dementia with Lewy bodies (DLB). This Phase 2a trial, expected to be completed in early 2025, aims to determine whether lamotrigine can protect DLB patients from functional decline, cognitive fluctuation, and hyperexcitability.

Study Design and Objectives

• The trial will enroll 60 patients aged 60 and older from Severance Hospital in Seoul, Korea.
• Participants will be randomized 1:1 to receive either standard of care (rivastigmine) plus oral lamotrigine or a matching placebo for 20 weeks.
• The primary efficacy endpoint is the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at Week 20.
• Secondary endpoints include Mini Mental State Examination, CDR, Caregiver Administered-Neuropsychiatric Inventory, Mayo Fluctuation Scale, Timed Up and Go test, Unified Parkinson’s Rating Scale, quantitative EEG, and various biomarker assessments[1][4].

Dosage and Safety Evaluation

• The dosage of lamotrigine will start at 25 mg once daily for the first two weeks, increasing to 25 mg twice daily for weeks 2-4, and then to 50 mg twice daily for weeks 4-20, provided the drug is found to be safe.
• Safety and tolerability will be closely monitored throughout the study[1][4].

Market Analysis of Lamotrigine

Global Market Size and Growth

The global lamotrigine market is projected to grow at a compound annual growth rate (CAGR) of 5.00% from 2024 to 2031. As of 2024, the market size is estimated to be USD XX million, with North America holding the largest share of around 40% of the global revenue[2].

Regional Market Breakdown

• North America: This region is expected to grow at a CAGR of 3.2% from 2024 to 2031, driven by robust healthcare infrastructure, high diagnosis rates, and favorable reimbursement policies.
• Europe: Europe holds around 30% of the global revenue and is anticipated to grow at a CAGR of 3.5% from 2024 to 2031, fueled by expanding healthcare expenditure and initiatives promoting mental health awareness.
• Asia Pacific: This region is projected to grow at a CAGR of 7.0% from 2024 to 2031, driven by rising healthcare expenditure, improving access to healthcare services, and growing awareness about neurological and mood disorders.
• Latin America: Latin America is expected to grow at a CAGR of 4.4% from 2024 to 2031, driven by expanding healthcare infrastructure, increasing urbanization, and rising awareness about mental health[2].

Market Drivers

• Healthcare Infrastructure: Robust healthcare infrastructure in regions like North America and Europe supports the growth of the lamotrigine market.
• Mental Health Awareness: Increasing awareness about neurological and mood disorders drives diagnosis rates and treatment-seeking behavior.
• Aging Population: The aging population in various regions contributes to the demand for treatments targeting mood and neurological disorders.
• Pharmaceutical Innovations: The presence of leading pharmaceutical companies fosters innovation and market growth[2].

Safety and Efficacy of Lamotrigine

Clinical Trial Data

Historical clinical trials have shown lamotrigine to be effective and well-tolerated in both add-on and monotherapy treatments for epilepsy and bipolar disorder. Approximately 4000 adults have been treated with lamotrigine in Glaxo Wellcome-sponsored clinical trials, with most adverse events being mild or moderate in severity. The most concerning adverse event has been rash, particularly within the first 8 weeks of treatment, with a low incidence of Stevens-Johnson syndrome (SJS)[3].

Adverse Events and Safety Precautions

• Rash: The risk of rash is higher when exceeding recommended dosage guidelines or co-administering valproic acid. Early warnings and adherence to administration guidelines are crucial to reduce this risk.
• Vital Signs and Laboratory Data: Analysis has shown no undesirable effects of lamotrigine on major body systems[3].

Market Segments and Applications

Epilepsy

Lamotrigine is well-established in the management of epilepsy, particularly in hospital pharmacies. Its efficacy in both adult and pediatric populations makes it a preferred choice among healthcare providers[2].

Bipolar Disorder

Lamotrigine is effective in stabilizing mood swings in bipolar disorder, making it a key medication in this segment. Its use is particularly prominent in regions like Latin America, where bipolar disorder is a growing concern[2].

Emerging Applications

The ongoing trial in DLB highlights the potential of lamotrigine in treating other neurological conditions. Successful outcomes could expand its market beyond traditional applications, further solidifying its position in the pharmaceutical market[1][4].

Key Takeaways

• Clinical Trials: The ongoing Phase 2a trial is crucial for determining lamotrigine's efficacy in DLB, focusing on functional decline, cognitive fluctuation, and hyperexcitability.
• Market Growth: The global lamotrigine market is projected to grow at a CAGR of 5.00% from 2024 to 2031, driven by robust healthcare infrastructure, mental health awareness, and an aging population.
• Safety and Efficacy: Lamotrigine has been shown to be effective and well-tolerated in clinical trials, with a need for careful management of potential adverse events like rash.
• Market Segments: Lamotrigine dominates in the epilepsy segment and is significant in bipolar disorder treatment, with potential expansion into other neurological conditions.

FAQs

What is the primary objective of the ongoing Phase 2a clinical trial for lamotrigine in DLB?

The primary objective is to determine whether lamotrigine can protect patients with dementia with Lewy bodies from functional decline, cognitive fluctuation, and hyperexcitability.

What is the projected growth rate of the global lamotrigine market from 2024 to 2031?

The global lamotrigine market is projected to grow at a compound annual growth rate (CAGR) of 5.00% from 2024 to 2031.

Which region holds the largest share of the global lamotrigine market?

North America holds the largest share of around 40% of the global revenue as of 2024.

What are the common adverse events associated with lamotrigine?

The most concerning adverse event is rash, particularly within the first 8 weeks of treatment, with a low incidence of Stevens-Johnson syndrome (SJS).

In which neurological conditions is lamotrigine traditionally used?

Lamotrigine is traditionally used in the management of epilepsy and bipolar disorder.

Sources

1. A Randomized, Double-blind, Phase 2a Clinical Trial to Study the Efficacy and Safety of Lamotrigine for Treatment of Patients with Dementia with Lewy Bodies. MDS Abstracts.
2. Global Lamotrigine Market Report 2024. Cognitive Market Research.
3. Safety review of adult clinical trial experience with lamotrigine. PubMed.
4. Phase 2a Trial to Test Effects of Antiseizure Medication Lamotrigine in Dementia with Lewy Bodies. Neurology Live.