CLINICAL TRIALS PROFILE FOR LEVETIRACETAM IN SODIUM CHLORIDE

All Clinical Trials for LEVETIRACETAM IN SODIUM CHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.

Clinical Trial Conditions for LEVETIRACETAM IN SODIUM CHLORIDE

Condition Name

Condition Name for LEVETIRACETAM IN SODIUM CHLORIDE
Intervention	Trials
Epilepsy	50
Seizures	17
Epilepsy, Partial	13
Healthy	8

Condition MeSH

Condition MeSH for LEVETIRACETAM IN SODIUM CHLORIDE
Intervention	Trials
Epilepsy	82
Seizures	74
Epilepsies, Partial	20
Status Epilepticus	13

Clinical Trial Locations for LEVETIRACETAM IN SODIUM CHLORIDE

Trials by Country

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Trials by Country for LEVETIRACETAM IN SODIUM CHLORIDE
Location	Trials
United States	328
Japan	49
Germany	30
France	24
Italy	23

Trials by US State

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Trials by US State for LEVETIRACETAM IN SODIUM CHLORIDE
Location	Trials
Ohio	21
Maryland	20
California	19
Massachusetts	18
Texas	17

Clinical Trial Progress for LEVETIRACETAM IN SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for LEVETIRACETAM IN SODIUM CHLORIDE
Clinical Trial Phase	Trials
Phase 4	47
Phase 3	54
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for LEVETIRACETAM IN SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	138
Recruiting	23
Terminated	21

Clinical Trial Sponsors for LEVETIRACETAM IN SODIUM CHLORIDE

Sponsor Name

Sponsor Name for LEVETIRACETAM IN SODIUM CHLORIDE
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 IN SODIUM CHLORIDE
Sponsor	Trials
Other	246
Industry	130
NIH	19

Levetiracetam in Sodium Chloride: Clinical Trials, Market Analysis, and Projections

Introduction to Levetiracetam in Sodium Chloride

Levetiracetam in Sodium Chloride Injection is an antiepileptic drug used as adjunctive therapy for various seizure types in adults. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Indications and Usage

Levetiracetam in Sodium Chloride Injection is indicated for adults (16 years and older) with partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures, particularly when oral administration is temporarily not feasible[2][5].

Clinical Trial Outcomes

In controlled clinical studies, levetiracetam has shown efficacy in reducing the frequency of seizures. For instance, in trials using levetiracetam tablets, the drug was effective in treating myoclonic seizures, partial onset seizures, and primary generalized tonic-clonic seizures. The intravenous formulation mirrors the oral dosing regimen, ensuring equivalent therapeutic effects when oral administration is not possible[2].

Pharmacokinetics

A study on the pharmacokinetics of levetiracetam in critically ill adult patients highlighted the importance of renal function in drug clearance. The clearance of levetiracetam was strongly correlated with the estimated glomerular filtration rate (eGFR), indicating the need for dose adjustments in patients with renal impairment[4].

Market Analysis

Market Size and Growth

The global Levetiracetam market is expected to experience significant growth. From 2022 to 2029, the market is projected to expand due to increasing demand for antiepileptic drugs and the introduction of new formulations. The market size is anticipated to grow at a remarkable CAGR, driven by factors such as the rising prevalence of epilepsy and the need for effective adjunctive therapies[1][3].

Segmentation

The Levetiracetam market is segmented by product type (tablets, injections, solutions), application (medical treatment, scientific research), and geography (North America, Europe, Asia-Pacific, South America, Middle East, and Africa). The injection segment, particularly the sodium chloride formulation, is gaining traction due to its convenience and efficacy in acute settings[1][3].

Key Players

Major players in the Levetiracetam market include pharmaceutical companies like B. Braun Medical Inc., which recently launched a new line of Levetiracetam in Sodium Chloride Injection products. These companies are focusing on innovative packaging and formulations to enhance patient safety and convenience[1][5].

Market Projections

Forecast Period

From 2023 to 2031, the Levetiracetam Drugs Market is expected to exhibit robust growth. The market dynamics, including drivers such as increasing epilepsy prevalence, advancements in medical technology, and the expanding healthcare infrastructure, will contribute to this growth. However, restraints like regulatory challenges and competition from generic drugs may also influence the market[3].

Regional Growth

Geographically, the market is expected to grow significantly in regions like North America and Europe, driven by advanced healthcare systems and higher awareness of epilepsy treatments. The Asia-Pacific region is also anticipated to show substantial growth due to its large population and increasing healthcare expenditures[1][3].

Product Innovations

B. Braun's introduction of Levetiracetam in Sodium Chloride Injection in flexible PAB IV Containers is a notable innovation. These containers are biodegradable, free of DEHP, PVC, and natural rubber latex, and have an extended shelf life, which enhances patient safety and convenience[5].

Market Drivers and Challenges

Drivers

• Increasing Prevalence of Epilepsy: The rising number of epilepsy cases globally is a significant driver for the Levetiracetam market.
• Advancements in Medical Technology: Innovations in drug delivery systems, such as the intravenous formulation, are enhancing the market.
• Expanding Healthcare Infrastructure: Growing healthcare investments and infrastructure development in various regions are supporting market growth[1][3].

Challenges

• Regulatory Hurdles: Strict regulatory requirements can slow down the approval and launch of new products.
• Competition from Generics: The presence of generic versions of levetiracetam can impact the market share of branded products.
• Side Effects and Contraindications: Known hypersensitivity reactions and other adverse effects can limit the use of levetiracetam in certain patients[2][5].

Key Takeaways

• Clinical Efficacy: Levetiracetam in Sodium Chloride Injection is effective in treating various seizure types when oral administration is not feasible.
• Market Growth: The global Levetiracetam market is projected to grow significantly from 2023 to 2031, driven by increasing demand and innovative product formulations.
• Regional Expansion: North America, Europe, and the Asia-Pacific region are expected to be key growth areas.
• Product Innovations: Companies like B. Braun are introducing innovative packaging and formulations to enhance patient safety and convenience.

FAQs

What are the indications for Levetiracetam in Sodium Chloride Injection?

Levetiracetam in Sodium Chloride Injection is indicated for adjunctive therapy in adults with partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures when oral administration is temporarily not feasible[2][5].

What are the common adverse reactions associated with Levetiracetam?

Common adverse reactions include hematologic abnormalities, and in some cases, hypersensitivity reactions such as angioedema and anaphylaxis[2][5].

How is Levetiracetam in Sodium Chloride Injection administered?

It is administered intravenously over a 15-minute infusion period and is available in three different concentrations: 500 mg/100 mL, 1000 mg/100 mL, and 1500 mg/100 mL[2][5].

What are the key drivers of the Levetiracetam market growth?

The key drivers include the increasing prevalence of epilepsy, advancements in medical technology, and the expanding healthcare infrastructure[1][3].

Which regions are expected to show significant growth in the Levetiracetam market?

North America, Europe, and the Asia-Pacific region are anticipated to be key growth areas due to their advanced healthcare systems and increasing healthcare expenditures[1][3].

Sources

1. GlobeNewswire: Levetiracetam Market Size and Outlook to 2022-2029[1].
2. FDA: Levetiracetam in Sodium Chloride Injection Prescribing Information[2].
3. MarketResearchIntellect: Global Levetiracetam Drugs Market Size, Trends and Projections[3].
4. MDPI: The Pharmacokinetics of Levetiracetam in Critically Ill Adult Patients[4].
5. PR Newswire: B. Braun Launches Levetiracetam in Sodium Chloride Injection Portfolio[5].