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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR LEVETIRACETAM

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Clinical Trials for Levetiracetam

Trial ID Title Status Sponsor Phase Summary
NCT00015769 Pilot Study of Levetiracetam (Keppra® (Registered Trademark)) for Bipolar Illness Completed National Institute of Mental Health (NIMH) Phase 2 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 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 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.
NCT00076674 Levetiracetam Treatment of L-dopa Induced Dyskinesias Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Levetiracetam

Condition Name

Condition Name for Levetiracetam
Intervention Trials
Epilepsy 47
Seizures 14
Epilepsy, Partial 13
Healthy 8
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Condition MeSH

Condition MeSH for Levetiracetam
Intervention Trials
Epilepsy 65
Seizures 64
Epilepsies, Partial 20
Disease 7
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Clinical Trial Locations for Levetiracetam

Trials by Country

Trials by Country for Levetiracetam
Location Trials
United States 272
Japan 48
Germany 28
France 24
Italy 23
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Trials by US State

Trials by US State for Levetiracetam
Location Trials
Ohio 19
California 17
Texas 16
Maryland 16
Massachusetts 15
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Clinical Trial Progress for Levetiracetam

Clinical Trial Phase

Clinical Trial Phase for Levetiracetam
Clinical Trial Phase Trials
Phase 4 38
Phase 3 49
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Levetiracetam
Clinical Trial Phase Trials
Completed 120
Recruiting 20
Unknown status 15
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Clinical Trial Sponsors for Levetiracetam

Sponsor Name

Sponsor Name for Levetiracetam
Sponsor Trials
UCB Pharma 67
UCB Japan Co. Ltd. 10
National Institute of Neurological Disorders and Stroke (NINDS) 6
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Sponsor Type

Sponsor Type for Levetiracetam
Sponsor Trials
Other 164
Industry 116
NIH 14
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