CLINICAL TRIALS PROFILE FOR KEPPRA XR

All Clinical Trials for KEPPRA XR

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.
NCT00076674 ↗	Levetiracetam Treatment of L-dopa Induced Dyskinesias	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2004-01-01	This study will evaluate the effects of levetiracetam (Keppra (Trademark) on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. Levetiracetam blocks certain protein receptors on brain cells and thus can change the spread of brain signals believed to be affected in patients with Parkinson's disease. Patients between 30 and 80 years of age with relatively advanced Parkinson's disease and dyskinesias due to levodopa therapy may be eligible for this 6-week study. Screening and baseline evaluation - Participants are evaluated with a medical history, physical examination and neurologic evaluation, blood tests, urinalysis, electrocardiogram (EKG), 24-hour holter monitor (heart monitoring), and cardiology consultation. A chest x-ray and MRI or CT scan of the brain are done if needed. If possible, patients stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month (2 months if taking Selegiline) before the study begins and throughout its duration. (If necessary, patients may use short-acting agents, such as Mirapex, Requip or Amantadine.) Dose-finding phase - Patients are admitted to the NIH Clinical Center for 2 to 3 days for a levodopa "dose-finding" procedure. For this test, patients stop taking Sinemet and instead have levodopa infused through a vein. During the infusions, the drug dose is increased slowly until parkinsonian symptoms improve or unacceptable side effects occur or the maximum study dose is reached. Symptoms are monitored frequently. (Patients who have had dosing infusions in the last 3 months do not have to undergo this phase of the study.) Active study phase - Patients are randomly assigned to take levetiracetam or placebo ("sugar pill") twice a day for 6 weeks. At the end of weeks 1, 2 4, and 5, patients come to the clinic for blood tests, an EKG, and a review of adverse side effects. At the end of weeks 3 and 6, patients are hospitalized to study the response to treatment. They again stop taking Sinemet and selegiline and their ability to perform motor tasks is evaluated. They are then placed on an L-dopa infusion for 10 hours. Placebo may be infused at various times instead of L-dopa. Motor symptoms are evaluated several times during the infusion. Blood is drawn once during the infusion for research studies. Lumbar puncture - Patients undergo a lumbar puncture (spinal tap) at the end of weeks 1 and 4 to measure certain brain chemicals and drug levels. For this test, a local anesthetic is given and a needle is inserted in the space between the vertebrae in the lower back. About 2 tablespoons of fluid is collected through the needle. Magnetic resonance imaging (MRI) - Patients with changing disease activity may undergo MRIs at baseline, at the end of week 1 and at the end of the study to show changes in the brain. The patient lies in a narrow cylinder (the scanner) that uses radio waves and a magnetic field to produce images of the brain, which show structural and chemical changes. Follow-up - 2 weeks after the study ends, patients are contacted by phone for a review of side effects or they return to the clinic for an evaluation.
NCT00105040 ↗	A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures	Completed	UCB Pharma	Phase 2	2004-09-01	A 12-week Evaluation Period will be used to characterize potential cognitive and neuropsychological effects of LEV (20 - 60 mg/kg/day), as adjunctive treatment in children 4 - 16 years old, inclusive, with refractory partial onset seizures when compared to adjunctive treatment with placebo.
NCT00141115 ↗	Levetiracetam for the Treatment of Alcohol Dependence and Anxiety	Completed	UCB Pharma	Phase 2	2004-03-01	The purpose of this study is to determine if levetiracetam is effective in treating alcohol dependence in patients with anxiety symptoms. The researchers hypothesize that individuals are unable to reduce or discontinue alcohol use because of significant anxiety, mood, and sleep disturbance symptoms that accompany reduction in alcohol use.
NCT00141115 ↗	Levetiracetam for the Treatment of Alcohol Dependence and Anxiety	Completed	New York State Psychiatric Institute	Phase 2	2004-03-01	The purpose of this study is to determine if levetiracetam is effective in treating alcohol dependence in patients with anxiety symptoms. The researchers hypothesize that individuals are unable to reduce or discontinue alcohol use because of significant anxiety, mood, and sleep disturbance symptoms that accompany reduction in alcohol use.

Clinical Trial Conditions for KEPPRA XR

Condition Name

Condition Name for KEPPRA XR
Intervention	Trials
Epilepsy	27
Seizures	9
Epilepsy, Partial	9
Healthy	6

Condition MeSH

Condition MeSH for KEPPRA XR
Intervention	Trials
Seizures	42
Epilepsy	35
Epilepsies, Partial	12
Alcoholism	5

Clinical Trial Locations for KEPPRA XR

Trials by Country

Trials by Country for KEPPRA XR
Location	Trials
United States	201
Japan	41
Germany	14
Canada	11
Mexico	9

Trials by US State

Trials by US State for KEPPRA XR
Location	Trials
Ohio	15
California	15
Maryland	11
New York	11
Massachusetts	10

Clinical Trial Progress for KEPPRA XR

Clinical Trial Phase

Clinical Trial Phase for KEPPRA XR
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
Phase 4	24

Clinical Trial Status

Clinical Trial Status for KEPPRA XR
Clinical Trial Phase	Trials
Completed	74
Terminated	14
Recruiting	12

Clinical Trial Sponsors for KEPPRA XR

Sponsor Name

Sponsor Name for KEPPRA XR
Sponsor	Trials
UCB Pharma	41
UCB Japan Co. Ltd.	7
National Institute of Neurological Disorders and Stroke (NINDS)	5

Sponsor Type

Sponsor Type for KEPPRA XR
Sponsor	Trials
Other	115
Industry	64
NIH	12

Clinical Trials Update, Market Analysis, and Projection for KEPPRA XR

Last updated: November 1, 2025

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Introduction

Levetiracetam Extended Release (KEPPRA XR) represents a significant evolution in antiepileptic therapy, offering extended-release formulations designed to improve patient adherence and optimize seizure control. Since its inception, KEPPRA XR has attracted attention from clinicians, investors, and competitors, demanding a comprehensive analysis encompassing current clinical trial activity, market dynamics, and future growth potential.

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Clinical Trials Update

Ongoing and Recent Clinical Program

As of 2023, KEPPRA XR's clinical development remains robust, with multiple trials evaluating its efficacy and safety profile. The most recent updates include:

• Phase IV Post-Marketing Surveillance: A global study examining long-term safety and tolerability in diverse patient populations across various geographies. Data suggest a favorable safety profile consistent with earlier studies on levetiracetam's immediate-release (IR) form.
• Comparative Efficacy Trials: Ongoing randomized controlled trials (RCTs) comparing KEPPRA XR with other antiepileptic drugs (AEDs), focusing on seizure frequency reduction, cognitive outcomes, and quality of life measures.

Key Clinical Insights

• Enhanced Adherence: Extended-release formulations like KEPPRA XR demonstrate improved adherence due to reduced dosing frequency—typically once daily in contrast to IR formulations requiring multiple doses.
• Bioequivalence and Pharmacokinetics: Clinical pharmacology studies confirm that KEPPRA XR achieves similar plasma concentrations as KEPPRA IR, but with a more gradual absorption rate, potentially reducing side effects like dizziness and somnolence.
• New Pediatric Data: Trials targeting younger demographics have successfully demonstrated safety and efficacy, paving the way for potential label expansions.

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Market Analysis

Current Market Landscape

The epilepsy treatment market is sizable, with global sales exceeding $4 billion annually, driven by the chronic nature of the disease and the demand for effective, well-tolerated therapies.

• Key Competitors: Existing extended-release AEDs like once-daily formulations of topiramate, lamotrigine, and gabapentin account for competitive pressures.
• KEPPRA XR's Positioning: Leveraging the established efficacy of levetiracetam, KEPPRA XR benefits from existing prescriber familiarity and a strong safety reputation.

Market Penetration and Adoption

• Prescriber Acceptance: Neurophysicians and epileptologists increasingly favor extended-release formulations, citing better compliance rates.
• Patient Preference: Patients report improved convenience, fewer dosing errors, and less medication burden, translating into higher adherence rates.

Regulatory Environment

• Approval Status: As of 2023, KEPPRA XR has obtained regulatory approvals in major markets such as the US, EU, and Japan.
• Guideline Integration: The American Epilepsy Society and European Association of Neurophysiology incorporate KEPPRA XR into treatment algorithms as a first-line or adjunct therapy.

Distribution Channels

• Pharmacy Networks: Integration into hospital formularies and retail pharmacies facilitates broad access.
• Direct-to-Consumer Marketing: Targeted campaigns and patient education initiatives enhance awareness.

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Market Projection and Growth Drivers

Forecast Overview

Analysts project a compound annual growth rate (CAGR) of approximately 6-8% for KEPPRA XR over the next five years, driven by the increasing prevalence of epilepsy and the transition toward patient-friendly formulations.

Key Growth Factors

• Rising Epilepsy Prevalence: Approximately 50 million people globally suffer from epilepsy, with new cases emerging annually, creating expanding therapeutic needs [1].
• Shift from IR to XR: The paradigm shift favoring once-daily dosing enhances market penetration.
• Regulatory Expansions: Regulatory approvals in emerging markets and labels expanding for pediatric populations support broader usage.
• Pipeline Development: Additional formulations and combination products are under clinical evaluation, promising incremental growth.

Potential Challenges

• Generic Competition: The expiration of patents on the original levetiracetam formulation may lead to biosimilar entries, exerting price pressures.
• Pricing Pressures: Increased healthcare cost containment measures could impact margins.
• Market Saturation Risks: Limited incremental benefits over existing AEDs could slow adoption in some segments.

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Strategic Outlook

Pharmaceutical companies should focus on:

• Clinician Education: Emphasizing clinical benefits of KEPPRA XR, including adherence and tolerability.
• Pediatric and Geriatric Expansion: Targeting broader patient demographics through tailored clinical trials and regulatory submissions.
• Combination Therapies: Exploring synergistic formulations with other AEDs to widen indications.

A proactive approach to marketing, alongside continuous clinical research, will be crucial to capitalizing on KEPPRA XR’s growth potential.

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Key Takeaways

• KEPPRA XR maintains a strong clinical safety and efficacy profile, with ongoing studies reinforcing its position.
• The market for extended-release AEDs is expanding, driven by patient adherence benefits and prescriber preference.
• Regulatory approvals and existing infrastructure support rapid market penetration in key regions.
• Market growth projections remain favorable, propelled by rising epilepsy prevalence and evolving treatment paradigms.
• Competitive pressures necessitate strategic differentiation through clinical innovation and targeted marketing.

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FAQs

1. How does KEPPRA XR differ from the existing KEPPRA IR formulation?
KEPPRA XR offers once-daily dosing with pharmacokinetics similar to KEPPRA IR, but with a slower release profile that enhances adherence and potentially reduces side effects.

2. What is the current regulatory status of KEPPRA XR?
As of 2023, KEPPRA XR has received regulatory approval in major markets including the US, Europe, and Japan, with ongoing expansions into emerging markets.

3. Are there clinical data supporting KEPPRA XR's efficacy in pediatric patients?
Yes, recent pediatric trials affirm its safety and efficacy, supporting potential label extensions for younger populations.

4. What are the main competitors to KEPPRA XR in the AED market?
Competitors include extended-release formulations of topiramate, lamotrigine, and newer antiepileptic drugs like brivaracetam.

5. What are the primary growth drivers for KEPPRA XR over the next five years?
Key drivers include rising epilepsy prevalence, increased clinician acceptance of extended-release options, regulatory approvals, and demographic expansion to pediatric and geriatric patients.

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References

[1] World Health Organization. Epilepsy Factsheet. 2020.