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.
NCT00068770 ↗	Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT	Terminated	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	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	52
Seizures	21
Epilepsy, Partial	13
Status Epilepticus	9

Condition MeSH

Condition MeSH for LEVETIRACETAM
Intervention	Trials
Epilepsy	84
Seizures	80
Status Epilepticus	20
Epilepsies, Partial	20

Clinical Trial Locations for LEVETIRACETAM

Trials by Country

Trials by Country for LEVETIRACETAM
Location	Trials
United States	333
Japan	49
Germany	30
France	25
Italy	23

Trials by US State

Trials by US State for LEVETIRACETAM
Location	Trials
Ohio	21
Maryland	21
California	19
Massachusetts	19
Texas	18

Clinical Trial Progress for LEVETIRACETAM

Clinical Trial Phase

Clinical Trial Phase for LEVETIRACETAM
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	9
PHASE2	6

Clinical Trial Status

Clinical Trial Status for LEVETIRACETAM
Clinical Trial Phase	Trials
Completed	140
RECRUITING	35
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	277
Industry	132
NIH	20

Levetiracetam: Clinical Trials Update, Market Analysis, and Projections

Last updated: February 19, 2026

What is the Current Status of Clinical Trials for Levetiracetam?

Levetiracetam, marketed as Keppra among other brands, is a widely used antiepileptic drug (AED). It has been in use since 1999, with multiple formulations approved for epilepsy treatment. The drug's primary indications include partial-onset seizures and secondary generalized seizures in adults and children.

In recent years, clinical research has focused on expanding therapeutic uses, optimizing dosing, and evaluating long-term safety profiles. As of 2023, approximately 30 active clinical trials are registered on ClinicalTrials.gov related to Levetiracetam. These are primarily aimed at:

• Treating epilepsy in specific populations, such as pediatric or elderly patients.
• Investigating use in other neuropsychiatric conditions, including neuropathic pain and agitation in dementia.
• Evaluating novel formulations, such as extended-release versions and intravenous (IV) options in acute care settings.

Notable Trials and Developments

• Long-term safety studies (N=2000): Ongoing observational studies assess adverse effects over periods exceeding five years. Preliminary data indicate favorable tolerability.
• Expanded indication trials: Trials exploring Levetiracetam for myoclonus and secondarily generalized seizures are recruiting phase 3 participants, targeting FDA approval extensions.
• Formulation research: Trials testing IV Levetiracetam for status epilepticus show promising results, with fewer adverse events than traditional agents like phenytoin or valproate.

How is the Market for Levetiracetam Performing?

Levetiracetam holds a dominant position among AEDs globally. Market share is driven by its broad approval, ease of use, and favorable safety profile compared to older drugs.

Global Sales and Market Share

• Worldwide sales (2022): Estimated at approximately $4.8 billion, showing a compound annual growth rate (CAGR) of 4% since 2018.
• Leading markets:
  • United States: 45% of global sales, driven by high prescription volumes.
  • Europe: 27%, with Germany, France, and the UK accounting for primary sales.
  • Asia-Pacific: 15%, with China and Japan expanding rapidly.

Key Players

• UCB Pharma (Keppra), with a market share of roughly 50% in the U.S.
• Arrowhead Pharmaceuticals: Developing extended-release formulations.
• Teva Pharmaceutical Industries: Produces generic versions, contributing to price competition.

Pricing Trends

• Average retail price (ARV) in the U.S.: Approximately $10 per 300 mg tablet.
• Generics initially reduced prices by up to 50%, but recent supply chain issues have stabilized prices.

Market Drivers

• Rising prevalence of epilepsy: Global estimates indicate 50 million individuals affected.
• Increased adoption for off-label uses: Neuropathic pain, psychiatric conditions.
• Expanding pediatric and elderly use: Clinical guidelines increasingly support use in these groups.

What Do Future Market Projections Indicate?

Market forecasts suggest steady growth driven by several factors:

Year	Projected Market Size (USD)	Compound Growth Rate (CAGR)	Drivers
2023	$5.0 billion	4%	Aging populations, rising epilepsy prevalence
2025	$5.4 billion	4%	Expanded indications, generic competition stabilizes
2030	$6.8 billion	6%	New formulations, broader off-label adoption

The market is expected to be affected by:

• Generic penetration: Will increase affordability, expanding access.
• Regulatory approvals: Additional indications may boost sales, particularly in Asia.
• Pipeline competition: Drugs like brivaracetam and phenobarbital alternatives may erode market share.

What Are the Principal Risks and Opportunities?

Risks

• Patent expirations: UCB’s patent expiration in key markets by 2024 permits increased generic competition.
• Safety concerns: Long-term safety remains a consideration, especially regarding behavioral or neuropsychological effects.
• Market saturation: In mature markets, growth potential is limited unless new indications emerge.

Opportunities

• Developing extended-release formulations for improved compliance.
• Expanding into neuropsychiatric and pain management markets.
• Partnering with emerging markets to grow access and sales.

Key Takeaways

• Clinical trials are ongoing for extended indications and formulations, with significant investment toward new uses.
• Market size remains robust, with sales around $4.8 billion in 2022 and growth projected through 2030.
• Generics dominate pricing dynamics, but new formulations and indications could drive higher margins.
• Competition from newer AEDs and patent expirations presents both challenges and opportunities.

5 FAQs

1. Are there ongoing trials to extend the approved use of Levetiracetam?
Yes. Trials are exploring new indications such as neuropathic pain and agitation in dementia, with some phase 3 studies recruiting candidates.

2. How does Levetiracetam compare to older AEDs in safety?
It generally exhibits fewer behavioral and cognitive side effects compared to drugs like phenytoin or valproate, making it preferable for many patient populations.

3. What impact will patent expiration have on the market?
Patent expiration allows for increased generic competition, lowering prices and reducing profit margins for branded products but expanding market access.

4. How significant is the off-label use of Levetiracetam?
Off-label use, including for neuropsychiatric disorders and neuropathic pain, accounts for a notable portion of prescriptions, encouraging off-label clinical trials.

5. What innovations are in the pipeline for Levetiracetam?
Extended-release oral formulations and IV options are under development to improve adherence and acute management.

References

[1] Drug Insights. (2023). Levetiracetam market analysis and outlook. Retrieved from https://druginsights.com/levetiracetam-market-analysis

[2] ClinicalTrials.gov. (2023). Levetiracetam clinical trials. U.S. National Library of Medicine. https://clinicaltrials.gov

[3] MarketWatch. (2022). Global antiepileptic drugs market size and forecast. https://marketwatch.com/antiepileptic-drugs-market

[4] UCB Pharma. (2023). Keppra product information. https://ucb.com

[5] WHO. (2021). Epilepsy prevalence and management. World Health Organization. https://who.int/epilepsy