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Last Updated: January 11, 2025

CLINICAL TRIALS PROFILE FOR LAMICTAL ODT


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All Clinical Trials for lamictal odt

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00067938 ↗ Bipolar Study in Adults at Least 18 Years of Age Completed GlaxoSmithKline Phase 4 2003-08-01 Bipolar study of tolerability, clinical response and patient satisfaction
NCT00056277 ↗ Bipolar Disorder Study for Men and Women Completed GlaxoSmithKline Phase 3 2003-02-27 A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder
NCT00063362 ↗ Combination Therapy for the Treatment of Bipolar Disorders Terminated National Institute of Mental Health (NIMH) Phase 3 2002-02-01 This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.
NCT00063362 ↗ Combination Therapy for the Treatment of Bipolar Disorders Terminated University Hospitals Cleveland Medical Center Phase 3 2002-02-01 This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.
NCT00044278 ↗ Pediatric Epilepsy Study in Subjects 1-24 Months Completed GlaxoSmithKline Phase 2 2000-09-01 This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.
NCT00043875 ↗ Pediatric Epilepsy Trial in Subjects 1-24 Months Completed GlaxoSmithKline Phase 2 2000-05-01 This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for lamictal odt

Condition Name

242117600510152025Bipolar DisorderEpilepsyHealthyBipolar Depression[disabled in preview]
Condition Name for lamictal odt
Intervention Trials
Bipolar Disorder 24
Epilepsy 21
Healthy 17
Bipolar Depression 6
[disabled in preview] 0
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Condition MeSH

2724171700510152025Bipolar DisorderEpilepsyDiseaseDepression[disabled in preview]
Condition MeSH for lamictal odt
Intervention Trials
Bipolar Disorder 27
Epilepsy 24
Disease 17
Depression 17
[disabled in preview] 0
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Clinical Trial Locations for lamictal odt

Trials by Country

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Trials by Country for lamictal odt
Location Trials
United States 336
Germany 27
India 14
Italy 12
Korea, Republic of 8
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Trials by US State

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Trials by US State for lamictal odt
Location Trials
New York 20
Texas 17
Ohio 16
North Carolina 14
California 14
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Clinical Trial Progress for lamictal odt

Clinical Trial Phase

21.6%22.7%53.4%005101520253035404550Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for lamictal odt
Clinical Trial Phase Trials
Phase 4 19
Phase 3 20
Phase 2/Phase 3 2
[disabled in preview] 47
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Clinical Trial Status

84.0%7.4%001020304050607080CompletedTerminatedUnknown status[disabled in preview]
Clinical Trial Status for lamictal odt
Clinical Trial Phase Trials
Completed 79
Terminated 7
Unknown status 4
[disabled in preview] 4
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Clinical Trial Sponsors for lamictal odt

Sponsor Name

trials05101520253035GlaxoSmithKlineDr. Reddy's Laboratories LimitedNational Institute of Mental Health (NIMH)[disabled in preview]
Sponsor Name for lamictal odt
Sponsor Trials
GlaxoSmithKline 34
Dr. Reddy's Laboratories Limited 8
National Institute of Mental Health (NIMH) 7
[disabled in preview] 12
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Sponsor Type

51.0%40.3%6.7%001020304050607080OtherIndustryNIH[disabled in preview]
Sponsor Type for lamictal odt
Sponsor Trials
Other 76
Industry 60
NIH 10
[disabled in preview] 3
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Lamictal odt Market Analysis and Financial Projection

Lamictal ODT: Clinical Trials, Market Analysis, and Projections

Introduction

Lamictal ODT (lamotrigine orally disintegrating tablets) is a significant advancement in the treatment of epilepsy and bipolar disorder, offering a convenient and patient-friendly dosage form. Here, we will delve into the clinical trials, market analysis, and future projections for Lamictal ODT.

Clinical Trials and Efficacy

Approval and Clinical Evidence

Lamictal ODT has been approved by the FDA for various indications, including the long-term treatment of Bipolar I Disorder and the treatment of certain types of seizures. The approval was supported by extensive clinical trials, including those that utilized historic control methodologies to assess its efficacy as monotherapy for partial-onset seizures[1][4].

Monotherapy in Epilepsy

In the pivotal study LAM30055, Lamictal XR (the extended-release formulation of lamotrigine) demonstrated efficacy as monotherapy for patients aged 13 years and older who were receiving treatment with a single antiepileptic drug (AED). The study showed that doses of 250mg and 300mg per day were effective, with the 250mg dose being superior to the pseudoplacebo arm[1].

Bipolar Disorder

Lamictal ODT is indicated for the maintenance treatment of Bipolar I Disorder to delay the occurrence of mood episodes. Clinical trials have shown its effectiveness in this area, although it is not recommended for the treatment of acute manic or mixed episodes[4][5].

Market Analysis

Global Orally Disintegrating Tablet Market

The global orally disintegrating tablet (ODT) market, which includes Lamictal ODT, is projected to grow significantly. In 2023, the market size was estimated at USD 13.42 billion and is expected to reach around USD 31.80 billion by 2034, growing at a CAGR of 8.1% from 2024 to 2034[2].

Segmental Growth

The ODT market is driven by its convenience, improved drug absorption, and enhanced bioavailability. The segment for central nervous system (CNS) diseases, which includes epilepsy and bipolar disorder, is a major contributor to this growth. The U.S. market, in particular, is expected to grow from USD 3.48 billion in 2023 to around USD 8.42 billion by 2033, at a CAGR of 8.37%[2].

Regional Outlook

North America dominates the global ODT market, but the Asia Pacific region is also expected to grow significantly due to the increasing prevalence of chronic ailments and the growing emphasis on patient-centric healthcare solutions[2].

Market Projections

Increasing Demand for Patient-Friendly Dosage Forms

The demand for ODTs is rising due to their convenience, especially for older and pediatric patients who may have difficulty swallowing traditional tablets. This trend is expected to continue, driven by advancements in formulation technologies such as novel excipients and taste-masking strategies[2].

Therapeutic Applications

Lamictal ODT, being part of the broader ODT market, benefits from its diverse therapeutic applications. It is used not only for epilepsy and bipolar disorder but also for other CNS diseases, making it a versatile treatment option[2].

Technological Advancements

The ongoing research and development in ODT formulations aim to enhance their taste, stability, and bioavailability. These advancements are expected to further fuel the growth of the ODT market, including Lamictal ODT[2].

Regulatory and Clinical Trial Landscape

FDA Approval and Guidelines

The FDA has been supportive of the integration of omics data in clinical trial research, which can improve drug efficacy and safety. This regulatory environment is conducive to the development and approval of drugs like Lamictal ODT, which have undergone rigorous clinical trials[3].

Omics-Based Clinical Trials

The growing use of omics-based clinical trials, which provide valuable insights into patient-specific responses at a molecular level, is expected to enhance the development process of drugs like Lamictal ODT. This approach can streamline trial processes, improve efficacy, and reduce adverse effects[3].

Key Takeaways

  • Clinical Efficacy: Lamictal ODT has demonstrated efficacy in clinical trials for the treatment of epilepsy and bipolar disorder.
  • Market Growth: The global ODT market, including Lamictal ODT, is projected to grow significantly, driven by its convenience and improved drug absorption.
  • Regional Expansion: North America and the Asia Pacific region are key markets, with the latter expected to grow significantly due to increasing healthcare demands.
  • Technological Advancements: Ongoing research in ODT formulations is expected to enhance their therapeutic outcomes.
  • Regulatory Support: The FDA's supportive stance on omics-based clinical trials is beneficial for the development and approval of drugs like Lamictal ODT.

FAQs

What is Lamictal ODT used for?

Lamictal ODT is used for the long-term treatment of Bipolar I Disorder and for treating certain types of seizures, including partial-onset seizures and primary generalized tonic-clonic seizures[4][5].

What are the benefits of Lamictal ODT over traditional tablets?

Lamictal ODT offers improved convenience, especially for patients who have difficulty swallowing traditional tablets. It also enhances drug absorption and bioavailability[2].

What is the projected market size for the ODT market by 2034?

The global ODT market is projected to reach around USD 31.80 billion by 2034, growing at a CAGR of 8.1% from 2024 to 2034[2].

Which regions are expected to drive the growth of the ODT market?

North America currently dominates the market, but the Asia Pacific region is expected to grow significantly due to increasing healthcare demands and patient-centric solutions[2].

How do omics-based clinical trials impact the development of drugs like Lamictal ODT?

Omics-based clinical trials provide valuable insights into patient-specific responses, improving drug efficacy and safety. This approach can streamline trial processes and reduce adverse effects, supporting the development and approval of drugs like Lamictal ODT[3].

Sources

  1. FDA: "Lamotrigine Clinical PREA - FDA"[1]
  2. Precedence Research: "Orally Disintegrating Tablet Market Size to Hit USD 31.80 Bn by 2034"[2]
  3. BioSpace: "Omics-based Clinical Trials Market Size to Hit USD 70.92 Billion by 2034"[3]
  4. FDA: "LAMICTAL Tablets for Oral Suspension, LAMICTAL ODT Orally Disintegrating Tablets"[4]
  5. Pharmaceutical Technology: "Eurand Announces FDA Approval of EUR-1048 (Lamictal ODT)"[5]

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