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CLINICAL TRIALS PROFILE FOR OSU-6162
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Clinical Trials for OSU-6162
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT00499473 | Sunitinib in Treating Patients With Recurrent Malignant Gliomas | Completed | National Cancer Institute (NCI) | Phase 2 | This phase II trial is studying how well sunitinib works in treating patients with recurrent malignant gliomas. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. |
| NCT01739335 | Novel Therapeutics in Posttraumatic Stress Disorder (PTSD): A Randomized Clinical Trial of Mifepristone | Recruiting | VA Office of Research and Development | Phase 2 | Posttraumatic stress disorder (PTSD) is a common and disabling psychiatric disorder. Left untreated or under-treated, it can become a chronic condition associated with significant distress, depression, aggression, family disruption, and substance abuse. There is also accumulating evidence that combat-related PTSD is associated with an increased risk of morbidity and mortality. For the welfare of returning Veterans with PTSD and their families, it is critical that this disorder is promptly identified and effectively treated. Considerable advances that have been made in the assessment and treatment of PTSD in recent years; however, psychopharmacological treatments have been shown to be largely ineffective for Veterans with PTSD. To address this gap, this proposal seeks to test an innovative treatment approach in PTSD - pharmacological manipulation of the body's major stress system (the hypothalamic-pituitary-adrenal (HPA) axis) with mifepristone. At high doses mifepristone is a glucocorticoid receptor (GR) antagonist with peripheral and central nervous system effects, making it a compound of interest in the treatment of stress related disorders. There is abundant evidence of enhanced GR sensitivity in Veterans with PTSD which is thought to underlie some of the symptoms of PTSD and associated disturbances in mood and cognition. Thus, blockade of the GR receptor with mifepristone may target unique aspects of PTSD and lead to clinically meaningful improvement in symptoms and cognition. There is preliminary evidence that short-term mifepristone treatment has sustained beneficial effects on mood, cognition and sleep disturbance in some neuropsychiatric conditions (major depression, bipolar disorder, primary insomnia). That there can be sustained clinical and neuropsychological effects of mifepristone and normalization of basal HPA axis activity after drug discontinuation in these disorders, has led to the view that mifepristone's actions include recalibration of a dysregulated HPA axis. Accordingly, the investigators propose to study the effects of mifepristone in Veterans with chronic PTSD to determine if it is efficacious in improving PTSD symptoms and associated clinical outcomes. To better understand the mechanism of action of mifepristone the investigators propose to assess the effects of mifepristone on HPA axis activity and their relationship to treatment outcome and clinical response. To achieve these objectives, the investigators propose to conduct a Phase IIa, multi-site, double-blind, placebo controlled trial of mifepristone in Veteran outpatients with military-related PTSD through the VA's Cooperative Clinical Trial Award program. The investigators propose to enroll 90 unmedicated male Veterans with military related PTSD at four VA sites (Salisbury, NC, Bronx, NY, Durham, NC, and San Diego, CA). Eligible Veterans will be randomly assigned in parallel groups to treatment with 600 mg/day mifepristone or placebo for one week and followed for up to three months. In this initial trial the investigators propose to study the effects of mifepristone in Veterans with PTSD as monotherapy, rather than as an adjunctive treatment, in order to better detect a signal if there is one. The investigators will also describe the effects of mifepristone on several other clinical parameters including PTSD symptomology, depression severity, sleep quality, and functional impairment. Several measures of neuroendocrine functioning will also be obtained to explore the relationship of plasma cortisol and adrenocorticotropic hormone (ACTH) levels to clinical response and the time to addition of rescue medications. |
| NCT01999179 | Post-thrombotic Syndrome & Predictors of Recurrence in Catheter-related Thrombosis | Recruiting | Blood Center of Wisconsin | N/A | The goal of the pilot study is to determine if a multicenter prospective cohort study of cancer patients with blood clots associated with catheters is feasible. Cancer patients with catheter-related thrombosis treated with one month of anticoagulation will be evaluated for for post-thrombotic syndrome. Laboratory biomarkers will be evaluated as predictors of recurrent thrombosis. |
| NCT01999179 | Post-thrombotic Syndrome & Predictors of Recurrence in Catheter-related Thrombosis | Recruiting | Ohio State University | N/A | The goal of the pilot study is to determine if a multicenter prospective cohort study of cancer patients with blood clots associated with catheters is feasible. Cancer patients with catheter-related thrombosis treated with one month of anticoagulation will be evaluated for for post-thrombotic syndrome. Laboratory biomarkers will be evaluated as predictors of recurrent thrombosis. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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