CLINICAL TRIALS PROFILE FOR LEVETIRACETAM

All Clinical Trials for Levetiracetam

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00015769 ↗	Pilot Study of Levetiracetam (Keppra® (Registered Trademark)) for Bipolar Illness	Completed	National Institute of Mental Health (NIMH)	Phase 2	2001-04-01	This study will explore the possible effectiveness of levetiracetam in patients with bipolar illness who have not responded adequately to standard treatments. Levetiracetam was recently approved to treat seizures. Other drugs in the same class as levetiracetam, including carbamazepine and valproate, are widely recognized as substitute medications for lithium or are used as an adjunct to it, and other anticonvulsants have also shown promise in improving bipolar symptoms. Patients with bipolar illness whose manic, depressed or unstable moods are not adequately controlled by their current treatment and who have not responded previously to two standard treatments (i.e., lithium, valproate, carbamazepine or neuroleptics) may be eligible for this study. Participants will take levetiracetam starting at 500 mg daily. If this dose is well tolerated, it will be increased to 500 mg twice a day. Every 3 days, doses may be increased until the target dose of 3000 mg/day is reached. Higher doses, not to exceed 4000 mg/day, may be tried in patients who do not respond fully to the lower doses. Patients and observers will use standard ratings to evaluate the patients' response to therapy during the 8-week study. If, after 8 weeks, the results appear promising, patients may continue treatment for an additional 6 months to evaluate longer-term effects.
NCT00068770 ↗	Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT	Terminated	National Cancer Institute (NCI)	Phase 2	2003-10-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00068770 ↗	Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT	Terminated	Sidney Kimmel Comprehensive Cancer Center	Phase 2	2003-10-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.

Clinical Trial Conditions for Levetiracetam

Condition Name

Condition Name for Levetiracetam
Intervention	Trials
Epilepsy	50
Seizures	17
Epilepsy, Partial	13

Condition MeSH

Condition MeSH for Levetiracetam
Intervention	Trials
Epilepsy	82
Seizures	74
Epilepsies, Partial	20

Clinical Trial Locations for Levetiracetam

Trials by Country

Trials by Country for Levetiracetam
Location	Trials
United States	328
Japan	49
Germany	30
France	24
Italy	23

Trials by US State

Trials by US State for Levetiracetam
Location	Trials
Ohio	21
Maryland	20
California	19
Massachusetts	18
Texas	17

Clinical Trial Progress for Levetiracetam

Clinical Trial Phase

Clinical Trial Phase for Levetiracetam
Clinical Trial Phase	Trials
Phase 4	47
Phase 3	54
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Levetiracetam
Clinical Trial Phase	Trials
Completed	138
Recruiting	23
Terminated	21

Clinical Trial Sponsors for Levetiracetam

Sponsor Name

Sponsor Name for Levetiracetam
Sponsor	Trials
UCB Pharma	69
UCB Japan Co. Ltd.	11
National Institute of Neurological Disorders and Stroke (NINDS)	7

Sponsor Type

Sponsor Type for Levetiracetam
Sponsor	Trials
Other	246
Industry	130
NIH	19

Levetiracetam: Clinical Trials, Market Analysis, and Projections

Introduction

Levetiracetam, commonly known by the brand name Keppra, is a widely used antiepileptic medication. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials: Levetiracetam in Alzheimer's Disease

One of the recent clinical trials involving levetiracetam is the Levetiracetam for Alzheimer’s Disease–Associated Network Hyperexcitability (LEV-AD) study. This phase 2a randomized double-blinded placebo-controlled crossover clinical trial was conducted to assess the effect of levetiracetam on cognitive function in patients with Alzheimer's disease (AD)[1].

• Study Design: The trial involved 34 adults with AD, divided into two groups. Group A received a placebo for 4 weeks, followed by a 4-week washout period, and then levetiracetam (125 mg twice daily) for 4 weeks. Group B received the treatments in reverse order.
• Findings: The study found that treatment with levetiracetam did not significantly modify cognitive function in patients with AD. This suggests that, at the dosage used, levetiracetam may not be effective in improving cognitive outcomes in Alzheimer's patients.

Clinical Trials: Levetiracetam in Epilepsy

In the context of epilepsy, the SANAD II study is significant. This study compared the effectiveness and cost-effectiveness of levetiracetam, zonisamide, and lamotrigine in patients with newly diagnosed focal epilepsy[4].

• Study Design: The study was a randomized controlled trial that recruited patients from routine UK National Health Service clinics.
• Findings: Levetiracetam did not meet the criteria for non-inferiority in terms of time to 12-month remission compared to lamotrigine. It was also found to be inferior for time to treatment failure. Lamotrigine was superior in cost-utility analysis, indicating that levetiracetam and zonisamide are not cost-effective alternatives as first-line treatments.

Market Analysis

The global levetiracetam market is driven by several key factors:

Market Size and Growth

The global levetiracetam market size was significant in 2023, with a projected compound annual growth rate (CAGR) from 2024 to 2031. The market is segmented by type, application, and distribution channel, providing insights into the most lucrative segments and their expected growth rates[2].

Drivers

• Increasing Prevalence of Epilepsy: The rising prevalence of epilepsy and seizure disorders is a primary driver of the market. As more individuals are diagnosed and seek treatment, the demand for effective antiepileptic medications like levetiracetam grows[5].
• Innovation in Formulations: Extended-release versions and generic alternatives enhance patient convenience and affordability, widening the market reach.
• Pediatric Use: The approval of levetiracetam for use in children has expanded its patient base.
• Off-Label Use: The off-label use of levetiracetam in conditions like neuropathic pain and mood disorders is gaining recognition, further fueling market demand[5].

Regional Analysis

The market is segmented into major regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region provides revenue share, current trends, and future prospects, helping to understand the geographical distribution of the market[2].

Market Projections

Forecast Period

From 2024 to 2031, the levetiracetam market is expected to grow steadily. Here are some key projections:

• Global Market Size: The market size is estimated to increase significantly over the forecast period, driven by the factors mentioned above[2].
• Segment Analysis: The market will be driven by segments such as type (e.g., immediate-release and extended-release formulations) and application (e.g., epilepsy, Alzheimer's disease, and off-label uses)[2].
• Regional Growth: Asia Pacific and North America are expected to be key regions driving the market growth due to increasing awareness and diagnosis of epilepsy and other neurological conditions[2].

Competitive Landscape

The global epilepsy therapeutics market, which includes levetiracetam, is competitive with several key players. The market competition is expected to be influenced by the launch of new pipeline products and the performance of existing drugs like GW Pharmaceuticals’ Epidiolex and Zogenix’s flenfluramine[3].

Key Takeaways

• Clinical Trials: Levetiracetam did not show significant benefits in cognitive function for Alzheimer's patients but remains a viable option for epilepsy management, though with limitations compared to other antiepileptic drugs.
• Market Growth: The global levetiracetam market is expected to grow driven by increasing prevalence of epilepsy, innovative formulations, and expanded use in pediatric and off-label applications.
• Regional Insights: The market is segmented into major regions, with Asia Pacific and North America expected to be significant contributors to market growth.

FAQs

What was the outcome of the LEV-AD study on levetiracetam in Alzheimer's disease?

The LEV-AD study found that treatment with levetiracetam did not significantly modify cognitive function in patients with Alzheimer's disease[1].

How does levetiracetam compare to other antiepileptic drugs in terms of effectiveness?

In the SANAD II study, levetiracetam was found to be inferior to lamotrigine in terms of time to 12-month remission and time to treatment failure. Lamotrigine was also more cost-effective[4].

What are the key drivers of the global levetiracetam market?

The key drivers include the increasing prevalence of epilepsy, innovation in pharmaceutical formulations, approval for pediatric use, and off-label use in conditions like neuropathic pain and mood disorders[5].

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

Asia Pacific and North America are expected to be key regions driving the market growth due to increasing awareness and diagnosis of epilepsy and other neurological conditions[2].

What is the projected compound annual growth rate (CAGR) for the levetiracetam market from 2024 to 2031?

The exact CAGR is not specified in the sources, but the market is expected to grow steadily over the forecast period driven by several key factors[2].

Sources

1. LEV-AD Study: "Effect of Levetiracetam on Cognition in Patients With Alzheimer Disease: A Randomized Clinical Trial" - JAMA Neurology[1].
2. Global Levetiracetam Market Report: "Levetiracetam Market Report 2024 (Global Edition)" - Cognitive Market Research[2].
3. Epilepsy Market Forecast: "Epilepsy – Global Drug Forecast and Market Analysis to 2026" - GlobalData[3].
4. SANAD II Study: "The SANAD II study of the effectiveness and cost-effectiveness of levetiracetam, zonisamide, or lamotrigine for newly diagnosed focal epilepsy" - The Lancet[4].
5. Levetiracetam Manufacturing Plant Report: "Levetiracetam (Keppra) Manufacturing Plant Project Report 2024" - IMARC Group[5].