CLINICAL TRIALS PROFILE FOR LAMICTAL CD

All Clinical Trials for LAMICTAL CD

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for LAMICTAL CD

Condition Name

Condition Name for LAMICTAL CD
Intervention	Trials
Bipolar Disorder	24
Epilepsy	21
Healthy	17
Bipolar Depression	6

Condition MeSH

Condition MeSH for LAMICTAL CD
Intervention	Trials
Bipolar Disorder	27
Epilepsy	24
Disease	17
Depression	17

Clinical Trial Locations for LAMICTAL CD

Trials by Country

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Trials by Country for LAMICTAL CD
Location	Trials
United States	336
Germany	27
India	14
Italy	12
Korea, Republic of	8

Trials by US State

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−

Trials by US State for LAMICTAL CD
Location	Trials
New York	20
Texas	17
Ohio	16
California	14
North Carolina	14

Clinical Trial Progress for LAMICTAL CD

Clinical Trial Phase

Clinical Trial Phase for LAMICTAL CD
Clinical Trial Phase	Trials
Phase 4	19
Phase 3	20
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for LAMICTAL CD
Clinical Trial Phase	Trials
Completed	79
Terminated	7
Unknown status	4

Clinical Trial Sponsors for LAMICTAL CD

Sponsor Name

Sponsor Name for LAMICTAL CD
Sponsor	Trials
GlaxoSmithKline	34
Dr. Reddy's Laboratories Limited	8
National Institute of Mental Health (NIMH)	7

Sponsor Type

Sponsor Type for LAMICTAL CD
Sponsor	Trials
Other	76
Industry	60
NIH	10

Lamictal (Lamotrigine): Clinical Trials Update, Market Analysis, and Projections

Introduction

Lamictal, or lamotrigine, is a medication widely used for the treatment of epilepsy and bipolar disorder. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Epilepsy

Clinical trials have established the efficacy of Lamictal as monotherapy in adults with partial-onset seizures. Studies have shown that Lamictal is effective in converting patients from other antiepileptic drugs (AEDs) to monotherapy, particularly when the patient is receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate[1][4][5].

Bipolar Disorder

Lamictal is also indicated for the maintenance treatment of bipolar I disorder to delay the occurrence of mood episodes. Clinical trials have demonstrated its effectiveness in maintaining mood stability in patients treated for acute mood episodes with standard therapy[4].

Pediatric Patients

In pediatric patients, Lamictal has been evaluated for its safety and efficacy. Studies have shown that it can be effective in children aged 10 months to 11 years, although the pharmacokinetics and dosing may vary compared to adults[1][3].

Safety and Adverse Reactions

Rash and Dermatological Reactions

One of the significant concerns with Lamictal is the risk of severe dermatological reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These reactions are more common in pediatric patients and often occur within the first 2 to 8 weeks of treatment. However, cases have also been reported after prolonged treatment[1][4].

Other Adverse Reactions

Common adverse reactions in clinical trials include influenza, oropharyngeal pain, vomiting, contact dermatitis, upper abdominal pain, and suicidal ideation. The risk of these reactions highlights the need for careful monitoring and dose adjustment[3][4].

Pharmacokinetics

Absorption and Elimination

Lamictal exhibits linear pharmacokinetics, with plasma concentrations increasing in direct proportion to the dose administered. The drug has a half-life of approximately 25-30 hours in healthy volunteers, which can be affected by concomitant medications such as valproate and renal or hepatic impairment[1].

Self-Induction

Lamictal can induce its own metabolism, leading to a decrease in half-life and an increase in clearance over time. However, this self-induction may not occur when Lamictal is given as adjunctive therapy with certain other AEDs[1].

Market Analysis

Current Market

The market for antiepileptic and mood stabilizing drugs is significant, with Lamictal being one of the key players. However, the market analysis for Lamictal specifically is not as detailed as for other therapeutic areas like NSCLC, where market forecasts are more readily available.

Competitive Landscape

The antiepileptic drug market is competitive, with several other AEDs available. The market share of Lamictal can be influenced by factors such as the introduction of new drugs, generic competition, and changes in prescribing practices.

Future Projections

Generic Competition

As with many pharmaceuticals, the expiration of patents can lead to the introduction of generic versions, which can significantly impact the market share of the branded drug. For Lamictal, the potential for generic competition could reduce its market share over time[2].

Extended Release Formulations

The approval of extended-release formulations like Lamictal XR can provide additional benefits to patients, such as greater ease of compliance. This could help maintain or even increase market share despite generic competition[5].

Emerging Markets

While the NSCLC market analysis highlights significant growth in regions like China, the antiepileptic and bipolar disorder markets may also see growth in emerging economies. However, specific projections for Lamictal in these markets are not readily available.

Key Takeaways

• Efficacy: Lamictal is effective in treating epilepsy and bipolar disorder, with established clinical trial data.
• Safety: The drug carries a risk of severe dermatological reactions and other adverse effects, necessitating careful monitoring.
• Pharmacokinetics: Lamictal exhibits linear pharmacokinetics but can be affected by concomitant medications and organ impairment.
• Market: The competitive landscape and potential for generic competition will influence Lamictal's market share.
• Future Projections: Extended-release formulations and growth in emerging markets could support the drug's market position.

FAQs

Q: What are the primary indications for Lamictal?

A: Lamictal is indicated for the treatment of epilepsy and bipolar I disorder.

Q: What is the risk of severe dermatological reactions with Lamictal?

A: Severe dermatological reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, can occur, particularly in pediatric patients and within the first 2 to 8 weeks of treatment.

Q: How does Lamictal interact with other medications?

A: Lamictal can interact with other AEDs, such as valproate, which can affect its pharmacokinetics.

Q: What is the impact of generic competition on Lamictal's market share?

A: Generic competition can significantly reduce the market share of Lamictal as generic versions become available.

Q: Are there any benefits to using the extended-release formulation of Lamictal?

A: Yes, the extended-release formulation (Lamictal XR) can offer greater ease of compliance and may be beneficial for patients transitioning to monotherapy.

Sources

1. Lamictal Label - FDA.
2. NSCLC Market - Global Drug Forecast & Market Analysis to 2025 - GlobalData.
3. Pediatric Postmarketing Pharmacovigilance - FDA.
4. Lamictal Label (2021) - FDA.
5. Lamictal XR Clinical PREA - FDA.