CLINICAL TRIALS PROFILE FOR TRILEPTAL
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All Clinical Trials for TRILEPTAL
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00050934 ↗ | Pediatric Epilepsy Study | Completed | Novartis Pharmaceuticals | Phase 3 | 2002-06-01 | 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 | 2002-07-01 | 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 | 2005-04-07 | 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 | 2003-07-01 | 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 | Completed | Beth Israel Deaconess Medical Center | Phase 1/Phase 2 | 2007-05-25 | 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. |
| NCT00441142 ↗ | Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors | Completed | Dana-Farber Cancer Institute | Phase 1/Phase 2 | 2007-05-25 | 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. |
| NCT00441142 ↗ | Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors | Completed | Henry Ford Hospital | Phase 1/Phase 2 | 2007-05-25 | 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 | >Start Date | >Summary |
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