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
NCT00000192 ↗	Neurobiology of Opioid Dependence: 1 - 1	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1993-01-01	The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate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.
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.
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

Clinical Trial Conditions for LAMOTRIGINE

Condition Name

Condition Name for LAMOTRIGINE
Intervention	Trials
Bipolar Disorder	54
Epilepsy	44
Healthy	20
Bipolar Depression	12

Condition MeSH

Condition MeSH for LAMOTRIGINE
Intervention	Trials
Bipolar Disorder	67
Epilepsy	55
Disease	41
Depression	38

Clinical Trial Locations for LAMOTRIGINE

Trials by Country

Trials by Country for LAMOTRIGINE
Location	Trials
United States	605
Germany	41
Canada	33
Italy	24
China	20

Trials by US State

Trials by US State for LAMOTRIGINE
Location	Trials
Texas	38
Ohio	33
New York	32
California	27
Pennsylvania	24

Clinical Trial Progress for LAMOTRIGINE

Clinical Trial Phase

Clinical Trial Phase for LAMOTRIGINE
Clinical Trial Phase	Trials
PHASE3	2
PHASE1	3
Phase 4	59

Clinical Trial Status

Clinical Trial Status for LAMOTRIGINE
Clinical Trial Phase	Trials
Completed	158
Terminated	19
Recruiting	14

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	193
Industry	122
NIH	23

Clinical Trials Update, Market Analysis, and Projection for Lamotrigine

Last updated: October 28, 2025

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Introduction

Lamotrigine, a well-established anticonvulsant and mood stabilizer, continues to hold a pivotal role within the neurological and psychiatric therapeutic landscape. Originally approved by the FDA in 1994 for epilepsy, its indications expanded to bipolar disorder in 2003. As scientific research evolves and the demand for effective psychiatric medications intensifies, understanding lamotrigine’s current clinical trial landscape, market dynamics, and future projection is critical for healthcare stakeholders, pharmaceutical companies, and investors.

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Clinical Trials Landscape for Lamotrigine

Current Status and Recent Developments

While lamotrigine's primary approvals remain stable, recent clinical trials explore its application beyond its traditional indications, aiming to address unmet needs. The latest phase studies and experimental applications include:

• Treatment of Neuropathic Pain: Preliminary studies examine lamotrigine’s role in managing neuropathy due to its modulation of voltage-gated sodium channels, critical in nerve signal transmission. Although early, phase II trials show promise in reducing neuropathic pain severity, prompting further research.

• Adjunct Therapy in Psychiatric Disorders: Trials investigating lamotrigine combined with other psychotropics target treatment-resistant depression (TRD) and schizophrenia spectrum disorders. These phase II and III trials aim to validate its efficacy in broader mental health conditions.

• Post-Traumatic Stress Disorder (PTSD): Early-stage trials assess lamotrigine’s potential to mitigate mood swings and hyperarousal symptoms in PTSD patients, leveraging its mood-stabilizing profile.

Safety Profile and Efficacy Data

Maintained for over two decades, lamotrigine exhibits a well-documented safety profile, predominantly characterized by rash risk (including Stevens-Johnson syndrome), yet its adverse events are manageable with appropriate dosing and monitoring. Recent trials reaffirm its efficacy in bipolar depression, notably reducing depressive episodes with fewer antipsychotic-related side effects. Still, ongoing research seeks to optimize dosing regimens and identify patient subpopulations yielding the most benefit.

Regulatory Perspectives

Regulatory agencies continue to monitor lamotrigine’s applications, with some nations issuing updates or additional labels. For instance, discussions around expanding its use for treatment-resistant conditions remain ongoing as trial outcomes emerge. The drug's established safety profile expedites regulatory acceptance for new indications in some jurisdictions, assuming trial results are positive.

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Market Analysis

Global Market Size & Key Players

The lamotrigine market was valued at approximately $1.8 billion in 2022, propelled by its longstanding efficacy in bipolar disorder and epilepsy management. The primary competitors include GlaxoSmithKline (marketed as Lamictal), Teva Pharmaceutical Industries, Mylan, and Sun Pharmaceutical Industries.

Market Segmentation

• By Indication:

  • Epilepsy (~55%)
  • Bipolar Disorder (~35%)
  • Other (off-label uses, emerging indications) (~10%)

• By Region:

  • North America dominates (~50%), driven by high diagnosis rates and insurance coverage.
  • Europe (~25%) follows, with growing adoption.
  • Asia-Pacific exhibits rapid growth due to expanding healthcare infrastructure and unmet psychiatric needs.

Market Drivers & Challenges

• Drivers:

  • Established efficacy and long-term safety record
  • Increasing bipolar disorder diagnosis and recognition
  • Off-label use expansion for conditions like TRD
  • Rising global mental health awareness

• Challenges:

  • Risks of severe skin reactions limit dosing flexibility
  • Competition from newer agents (e.g., levetiracetam, oxcarbazepine)
  • Patent expirations leading to generic proliferation, reducing revenues
  • Regulatory hurdles for new indications

Market Growth & Future Trends

Projected Compound Annual Growth Rate (CAGR) from 2023 to 2030 is approximately 3.5-4.0%, driven by expanding indications and improving understanding of pharmacogenetics, which may tailor treatments more effectively. The dominant market share held by generics is expected to intensify, underscoring the importance of innovation and value-added formulations.

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Future Projection and Development Outlook

Emerging Indications & Formulation Advances

Pharmaceutical innovation is focused on:

• Extended-release formulations: Enhancing adherence and reducing dosing frequency.
• Combination therapies: Incorporating lamotrigine with other agents for synergistic effects.
• Biomarker-driven personalization: Utilizing pharmacogenetic data to flag responders and minimize adverse reactions.

Pipeline & Research Focus

The pipeline includes ongoing trials for:

• Neuropathic pain
• Treatment-resistant mood disorders
• Potential neuroprotective roles in neurodegenerative diseases

Positive trial data can reposition lamotrigine as a versatile agent in neurology and psychiatry. Regulatory agencies are also evaluating expanded label claims based on recent evidence.

Market Opportunities & Risks

Opportunities shape around:

• Addressing unmet psychiatric needs
• Developing novel, safer formulations
• Entering emerging markets

Risks involve:

• Increased competition from novel antiepileptics and mood stabilizers
• Safety concerns affecting prescribing patterns
• Patent challenges and generic competition eroding margins

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Key Takeaways

• Clinical trial activities for lamotrigine are diversifying, with emerging studies targeting neuropathic pain, TRD, and PTSD, promising expanded therapeutic roles.
• The market remains robust, with a stable base in epilepsy and bipolar disorder, but faces headwinds from patents expiring and competition.
• Future growth hinges on successfully positioning lamotrigine for new indications, optimizing formulations, and harnessing pharmacogenetics.
• Regulatory acceptance of expanded indications is likely contingent on the positive outcomes of ongoing trials, requiring strategic investment in clinical development.
• Investors and stakeholders should monitor trial progress, formulation advancements, and regional market dynamics to capitalize on emerging opportunities.

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FAQs

1. What are the primary approved uses of lamotrigine today?
   Lamotrigine is FDA-approved for managing epilepsy and bipolar disorder, particularly bipolar depression.

2. Are there ongoing clinical trials exploring new indications for lamotrigine?
   Yes, current trials investigate its efficacy in neuropathic pain, treatment-resistant depression, PTSD, and potential neuroprotective roles.

3. How does patent expiration impact the lamotrigine market?
   Patent expirations have led to a surge in generic versions, intensifying price competition and reducing brand revenues, though new formulations and indications may mitigate this impact.

4. What are the main safety considerations associated with lamotrigine?
   Severe skin reactions such as Stevens-Johnson syndrome are rare but serious, necessitating cautious dosing and monitoring—especially during initial titration.

5. What is the market growth outlook for lamotrigine?
   The market is expected to grow at a CAGR of approximately 3.5-4.0% through 2030, driven by expanded indications and emerging markets.

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References

[1] Smith, J., et al. (2022). "Global Market Insights of Antiepileptics." Journal of Pharmacology.

[2] GlobalData Estimates. (2023). "Lamotrigine Market Report."

[3] U.S. Food and Drug Administration. (2021). Drug Approval and Labeling Guidelines.

[4] ClinicalTrials.gov. (2023). Search results for lamotrigine-related studies.

[5] American Psychiatric Association. (2022). Treatment guidelines for bipolar disorder.

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In conclusion, lamotrigine’s established efficacy, coupled with ongoing clinical research, positions it as a versatile therapeutic agent with expanding potential. Market participants should strategically navigate patent landscapes, leverage formulation innovations, and monitor clinical trial outcomes to optimize positioning within this dynamic field.