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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR TRILEPTAL

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Clinical Trials for Trileptal

Trial ID Title Status Sponsor Phase Summary
NCT00050934 Pediatric Epilepsy Study Completed Novartis Pharmaceuticals Phase 3 This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
NCT00050947 Pediatric Epilepsy Study Completed Novartis Pharmaceuticals Phase 3 This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
NCT00108056 Enzastaurin to Treat Recurrent Brain Tumor Terminated National Cancer Institute (NCI) Phase 1 This study will examine the safety of a twice-a-day dosing regimen of the experimental drug Enzastaurin in patients with malignant glioma (a cancerous brain tumor) who are and who are not taking certain anti-seizure medicines. Enzastaurin may prevent the formation of new blood vessels that tumors need to grow. It has shown some effect against brain tumors in animals and in some patients with recurrent gliomas. This study will see if the drug can help patients with gliomas and how much drug they should be given. Patients 18 years of age and older with malignant glioma that has recurred after standard therapy may be eligible for this study. Candidates are screened with a physical examination, blood and urine tests, magnetic resonance imaging (MRI) or computed tomography (CT) scans, and an electrocardiogram. Participants are divided into two groups of patients-those who are and those who are not taking certain anti-seizure medications-in order to determine if the anti-seizure medication alters the way the body handles Enzastaurin. Patients in both groups are further divided into different dosing regimens: some in each group take Enzastaurin once a day for 3 weeks, followed by twice a day for 3 weeks; others in the group take the drug twice a day for 3 weeks followed by once a day for 3 weeks. The medication is taken by mouth every day. Treatment is given in 6-week cycles and may continue for 1 year unless the tumor grows or the patient develops unacceptable drug side effects. In addition to drug treatment, patients have the following tests and procedures: - Medical history, physical, and neurological examinations every 3 weeks during the first cycle and then every 6 weeks. - MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. CT uses x-rays to provide 3-dimensional views of the part of the body being studied. For both procedures, the patient lies on a table that slides into the cylindrical scanner. - Routine blood tests every week during the first cycle and every 3 weeks after that. - Electrocardiogram on days 21 and 42 of the first cycle, just before taking the drug and 30 minutes and 4 hours after taking the drug. - Pharmacokinetic studies within 3 days of day 21 of the first cycle. Several blood samples are drawn to measure levels of Enzastaurin. Patients taking the drug once a day have blood samples drawn before the morning dose and 1, 2, 4, 6 and 24 hours after the dose. Patients taking the drug twice a day have samples drawn before the morning dose, at 1, 2, 4, 6 and 12 hours after the dose, and then 12 hours after the evening dose. In addition, on day 1 an extra tube of blood is drawn at the time of the Enzastaurin dose and 4 hours later. - Dynamic MRI with spectroscopy or PET. These tests are done to help distinguish live tumor from dying tumor. The experience of dynamic MRI with spectroscopy is the same as standard MRI and is done at the same time as the standard procedure. PET uses a radioactive substance to show cellular activity in specific tissues of the body. The patient is given an injection of a sugar solution in which a radioactive isotope has been attached to the sugar molecule. A special camera detects the radiation emitted by the radioisotope, and the resulting images show how much glucose is being used in various parts of the body. Because rapidly growing cells, such as tumors, take up and use more glucose than normal cells do, this test can be used to show active tumors.
NCT00206778 Six Month Trial of Lamotrigine vs. Sodium Valproate for Treatment of Mixed Mania Completed Beth Israel Medical Center Phase 2 We are comparing the efficacy of Lamotrigine to that of Standard of Care Sodium Valproate for the treatment of Mixed Mania. The study hypothesis is that Lamotrigine will be more efficative for treating mixed mania in patients with Bipolar Disorder.
NCT00441142 Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors Active, not recruiting Beth Israel Deaconess Medical Center Phase 1/Phase 2 Phase I: The purpose of this research study is to determine the safety of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. We will determine the highest dose of ZD6474 (Vandetanib) that can be given safely when combined with temozolomide (Temodar) and radiation therapy. Phase II: The purpose of this research study is to determine the efficacy of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. All subjects participating in this research study must NOT be taking a certain type of anti-seizure medication called enzyme inducing anticonvulsant drugs. These drugs include (but are not limited to) the following medications: Dilantin, Tegretol, Phenobarbital and trileptal.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Trileptal

Condition Name

Condition Name for Trileptal
Intervention Trials
Epilepsy 6
Healthy 4
Seizures 3
Bipolar Depression 1
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Condition MeSH

Condition MeSH for Trileptal
Intervention Trials
Epilepsy 3
Seizures 3
Bipolar Disorder 3
Glioma 1
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Clinical Trial Locations for Trileptal

Trials by Country

Trials by Country for Trileptal
Location Trials
United States 40
Canada 4
Germany 2
Brazil 2
Mexico 2
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Trials by US State

Trials by US State for Trileptal
Location Trials
New York 4
Michigan 3
Pennsylvania 3
Missouri 3
California 2
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Clinical Trial Progress for Trileptal

Clinical Trial Phase

Clinical Trial Phase for Trileptal
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Trileptal
Clinical Trial Phase Trials
Completed 12
Active, not recruiting 1
Terminated 1
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Clinical Trial Sponsors for Trileptal

Sponsor Name

Sponsor Name for Trileptal
Sponsor Trials
Roxane Laboratories 3
Novartis Pharmaceuticals 2
Ranbaxy Laboratories Limited 2
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Sponsor Type

Sponsor Type for Trileptal
Sponsor Trials
Other 17
Industry 10
NIH 1
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Accenture
Deloitte
Citi
Merck
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Queensland Health

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