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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR KEPPRA XR

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Clinical Trials for Keppra Xr

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.
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.
NCT00146471 Efficacy and Safety of Levetiracetam in the Inpatient Treatment of Alcohol Withdrawal Syndrome Completed Charite University, Berlin, Germany Phase 3 The purpose of this study is to evaluate the efficacy and safety of levetiracetam for treating alcohol withdrawal syndrome (AWS) in inpatients (vs. placebo). The primary come-out parameter is the reduction of the total needed amount of diazepam for add-on treatment of acute alcohol withdrawal symptoms. The secondary come-out parameter are - safety criteria (AE) - reduction of alcohol withdrawal score over the days.
NCT00150709 A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy Completed UCB Pharma Phase 3 The open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.
NCT00152516 Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures Completed UCB Pharma Phase 3 To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.
NCT00160654 Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy Completed UCB Pharma Phase 4 Community based study assessing safety and efficacy of levetiracetam in partial onset seizures. The optimal dose in daily clinical practice will be used.
NCT00181116 Levetiracetam for Benign Rolandic Epilepsy Completed UCB Pharma Phase 4 This study is designed to test if the language problems commonly seen in children with benign rolandic epilepsy would improve by switching anticonvulsants to levetiracetam.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Keppra Xr

Condition Name

Condition Name for Keppra Xr
Intervention Trials
Epilepsy 19
Healthy 6
Seizures 5
Epilepsy, Partial 4
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Condition MeSH

Condition MeSH for Keppra Xr
Intervention Trials
Seizures 22
Epilepsy 18
Epilepsies, Partial 7
Alcoholism 3
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Clinical Trial Locations for Keppra Xr

Trials by Country

Trials by Country for Keppra Xr
Location Trials
United States 110
Japan 15
Germany 10
Mexico 8
Poland 4
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Trials by US State

Trials by US State for Keppra Xr
Location Trials
Ohio 10
California 9
Pennsylvania 6
New York 6
New Jersey 6
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Clinical Trial Progress for Keppra Xr

Clinical Trial Phase

Clinical Trial Phase for Keppra Xr
Clinical Trial Phase Trials
Phase 4 20
Phase 3 12
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Keppra Xr
Clinical Trial Phase Trials
Completed 47
Recruiting 7
Unknown status 4
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Clinical Trial Sponsors for Keppra Xr

Sponsor Name

Sponsor Name for Keppra Xr
Sponsor Trials
UCB Pharma 27
UCB Japan Co. Ltd. 3
Charite University, Berlin, Germany 2
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Sponsor Type

Sponsor Type for Keppra Xr
Sponsor Trials
Other 61
Industry 38
NIH 4
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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Medtronic
Argus Health
Chinese Patent Office
Cipla
Cerilliant
Daiichi Sankyo
Harvard Business School
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