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
Epilepsy, Partial	9
Seizures	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

Keppra XR: Clinical Trial Update, Market Analysis, and Projection

Last updated: February 19, 2026

What is the current status of Keppra XR clinical trials?

Keppra XR (levetiracetam extended-release), marketed by UCB Pharma, is an established antiepileptic drug primarily used for the treatment of partial-onset seizures, myoclonic seizures, and generalized tonic-clonic seizures in epilepsy patients. As of the latest available data, no new Phase I, II, or III clinical trials for novel indications or significant new formulations of Keppra XR are actively being initiated or recruiting. The drug's efficacy and safety profile are well-documented through extensive prior clinical development and post-marketing surveillance.

Current activity largely revolves around post-marketing studies and real-world evidence gathering. These efforts focus on:

• Long-term safety and efficacy: Monitoring patient outcomes over extended periods to identify any rare adverse events or changes in effectiveness.
• Comparative effectiveness: Studies designed to compare Keppra XR's performance against newer antiepileptic drugs (AEDs) in specific patient populations or seizure types.
• Pharmacoeconomic analyses: Evaluating the cost-effectiveness of Keppra XR in real-world healthcare settings, especially in comparison to generics and newer branded agents.
• Special populations: Investigating the drug's use and safety in specific groups, such as elderly patients, pregnant women, or individuals with co-morbidities.

Past pivotal trials established Keppra XR's efficacy, notably demonstrating non-inferiority to immediate-release formulations in controlling seizures. For instance, a multicenter, double-blind, randomized, parallel-group study involving over 500 patients demonstrated that Keppra XR achieved comparable seizure control rates to immediate-release Keppra when used as adjunctive therapy for partial-onset seizures [1]. Another key trial established its efficacy as monotherapy for partial-onset seizures in adults.

What is the current market landscape for Keppra XR?

The market for Keppra XR is characterized by a mature product facing significant generic competition, alongside a dynamic landscape of newer antiepileptic drugs.

Key Market Factors:

• Generic Erosion: The patent expiry of Keppra (and subsequently Keppra XR) has led to the widespread availability of generic levetiracetam. This has dramatically reduced the market share and revenue for UCB Pharma's branded Keppra XR. Generic levetiracetam is available in both immediate-release and extended-release formulations, directly competing with Keppra XR.
• Established Efficacy: Despite generic competition, Keppra XR retains a market position due to its well-established efficacy and tolerability profile. It is often prescribed by neurologists as a first or second-line treatment option.
• Therapeutic Equivalency: Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), classify generic levetiracetam as therapeutically equivalent to Keppra XR, meaning they are expected to have the same clinical effect and safety profile. This facilitates the substitution of generics by pharmacies.
• Newer AEDs: The AED market is continuously evolving with the introduction of novel drugs offering different mechanisms of action, improved tolerability, or efficacy in specific seizure types or refractory epilepsy. These include drugs like Xcopri (cenobamate), Brivlera (brivaracetam, also by UCB), and Epidiolex (cannabidiol). While these newer drugs compete for market share, they often target different patient segments or refractory cases, allowing established drugs like Keppra XR to maintain a presence.
• UCB's Strategy: UCB Pharma has focused on differentiating its offerings through Brivlera (brivaracetam), a structural analog of levetiracetam with a potentially improved tolerability profile and different binding affinity to synaptic vesicle protein 2A (SV2A).

Market Share and Revenue Trends:

Precise current market share figures for branded Keppra XR are difficult to isolate from generic levetiracetam sales due to reporting consolidation. However, industry analyses indicate a substantial decline in branded Keppra XR revenue post-patent expiry.

• Pre-Generic (2010-2013): Branded Keppra (and its XR formulation) generated annual revenues exceeding $1 billion globally.
• Post-Generic (2014 onwards): Revenues for branded Keppra XR have significantly decreased, with a substantial portion of the market now captured by generic manufacturers. UCB's overall epilepsy portfolio revenue has shifted towards newer products like Brivlera.

Competitive Landscape Snapshot (Partial List):

Drug Name	Active Ingredient	Company	Primary Indication(s)	Status of Keppra XR Competition
Keppra XR	Levetiracetam ER	UCB Pharma	Partial-onset seizures, myoclonic seizures, GTCS	Branded; faces significant generic levetiracetam competition.
Generic Levetiracetam XR	Levetiracetam ER	Multiple	Partial-onset seizures, myoclonic seizures, GTCS	Direct competitor, offering lower price points.
Brivlera	Brivaracetam	UCB Pharma	Adjunctive therapy for partial-onset seizures	Newer UCB product, potential differentiation via mechanism.
Xcopri	Cenobamate	SK Life Science	Adjunctive therapy for partial-onset seizures	Novel mechanism, strong clinical data, emerging competitor.
Epidiolex	Cannabidiol	GW Pharma	Seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, Tuberous Sclerosis Complex	Different indication focus, less direct competition.
Vimpat	Lacosamide	UCB Pharma	Adjunctive therapy for partial-onset seizures, primary generalized tonic-clonic seizures	Established branded AED, also from UCB.

What are the market projections for Keppra XR?

Market projections for Keppra XR are largely shaped by the continued dominance of generic levetiracetam and the evolving competitive landscape of newer AEDs. The branded Keppra XR product itself is unlikely to see significant growth.

Key Projection Drivers:

• Sustained Generic Penetration: Generic levetiracetam, in both immediate-release and extended-release formulations, will continue to hold the largest share of the levetiracetam market. Price competition among generic manufacturers will remain intense.
• Pricing Pressures: The overall pricing environment for AEDs is subject to significant pressure from payers and healthcare systems seeking cost containment. This directly impacts the profitability of branded Keppra XR.
• Limited New Indications or Formulations: Without significant clinical development for new indications or a next-generation formulation, branded Keppra XR will not benefit from new market opportunities.
• Competition from Novel Therapies: As newer AEDs with novel mechanisms of action and potentially improved efficacy or tolerability profiles gain market traction, they will continue to draw patients and prescribers away from older, more established drugs, including branded Keppra XR.
• UCB's Portfolio Shift: UCB Pharma's strategic focus has shifted towards its newer epilepsy treatments, such as Brivlera and potentially future pipeline assets. This implies a diminished emphasis on promoting the branded Keppra XR product.
• Established but Aging Franchise: Keppra XR (and its generic equivalents) will likely remain a widely used treatment option due to its proven track record, particularly in managed care formularies where cost-effectiveness is a primary consideration. However, its market share within the broader epilepsy therapeutic class will gradually decrease.

Projected Market Trends:

• Branded Keppra XR: Expect continued low single-digit (or negative) annual revenue growth for branded Keppra XR. Its market share will gradually erode as generic penetration deepens and newer therapies are adopted.
• Generic Levetiracetam: The generic levetiracetam market (including XR formulations) will remain substantial, driven by cost-conscious healthcare systems and payers. This segment will continue to represent the majority of total levetiracetam usage.
• Epilepsy Market: The overall epilepsy market is projected to grow, driven by an aging population, increased diagnosis rates, and the development of novel therapies. However, this growth will primarily benefit newer drugs rather than mature brands like Keppra XR.

Estimated Market Size and Growth (Levetiracetam Market - Branded & Generic):

Estimating the precise future market for "Keppra XR" becomes complex when including generics. However, the broader levetiracetam market (encompassing both branded and generic forms) is projected to experience moderate growth, with the majority of value residing in generic forms.

• Current Global Levetiracetam Market (Estimated 2023): $1.5 - $2.0 billion (including branded and generics). Branded Keppra XR likely contributes a small fraction of this.
• Projected Global Levetiracetam Market (2028): $1.8 - $2.3 billion. Growth will be driven by volume, with pricing remaining competitive, especially for generics.

The market for branded Keppra XR itself is projected to remain stable to declining, with revenues primarily influenced by contractual agreements and formulary placement. Its strategic importance to UCB is likely to diminish in favor of Brivlera and other newer assets.

Key Takeaways

• Keppra XR clinical development is focused on post-marketing surveillance and real-world evidence, with no new pivotal trials for novel indications or formulations.
• The market for Keppra XR is dominated by generic levetiracetam, significantly impacting branded product revenue.
• Newer antiepileptic drugs with novel mechanisms are increasingly competing for market share in the epilepsy space.
• Projections indicate continued decline for branded Keppra XR revenue, while the overall generic levetiracetam market will remain substantial due to cost-effectiveness.
• UCB Pharma's strategic focus has shifted to newer epilepsy assets, diminishing the promotional emphasis on branded Keppra XR.

Frequently Asked Questions

What is the primary reason for the decline in Keppra XR's branded market share?

The primary reason is the expiration of key patents, leading to extensive generic competition. This allows multiple manufacturers to produce and sell levetiracetam at significantly lower prices, eroding the market share and revenue of the branded product.

Are there any new clinical trials exploring different uses for Keppra XR?

As of current data, there are no major new clinical trials initiated for novel indications or significant new formulations of Keppra XR. The drug's established efficacy and safety profile are well-documented from its initial development and post-marketing studies.

How does Keppra XR compare to its successor, Brivlera?

Brivlera (brivaracetam) is a structural analog of levetiracetam, also developed by UCB Pharma. While both target the SV2A protein, Brivlera has a higher affinity for SV2A and a different binding profile, which may lead to differentiated clinical effects and potentially improved tolerability in some patients. Brivlera is positioned as a newer option with distinct characteristics.

What is the projected impact of biosimilar competition on Keppra XR?

Keppra XR is a small molecule drug, not a biologic. Therefore, the concept of biosimilar competition, which applies to biologic drugs, is not relevant. The competition for Keppra XR comes from generic, small-molecule versions of levetiracetam.

What are the key factors driving the continued use of generic levetiracetam?

Key drivers include significantly lower costs compared to branded Keppra XR, established efficacy supported by extensive clinical data, and broad formulary inclusion by payers and healthcare systems prioritizing cost-effectiveness. Its well-understood safety profile also contributes to its continued prescription.

Citations

[1] Privitera, M. D., Neufeld, M. J., Kramer, G., Doty, P., & Schiemann, A. L. (2008). Levetiracetam extended-release versus levetiracetam immediate-release as adjunctive therapy for partial-onset seizures: a multicenter, double-blind, randomized, parallel-group study. Epilepsia, 49(9), 1537-1546. https://doi.org/10.1111/j.1528-1169.2008.01690.x