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Last Updated: December 11, 2019

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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 >Phase >Summary

Clinical Trial Conditions for OSU-6162

Condition Name

Condition Name for
Intervention Trials
Adult Giant Cell Glioblastoma 1
Alzheimer Disease 1
Venous Thrombosis 1
Adult Diffuse Astrocytoma 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Postthrombotic Syndrome 1
Neurofibroma 1
Glioblastoma 1
Postphlebitic Syndrome 1
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Clinical Trial Locations for OSU-6162

Trials by Country

Trials by Country for
Location Trials
United States 13
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Trials by US State

Trials by US State for
Location Trials
Minnesota 2
California 2
Ohio 2
Missouri 1
Oregon 1
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Clinical Trial Progress for OSU-6162

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 3
Phase 1 1
Phase 0 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 4
Active, not recruiting 1
Completed 1
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Clinical Trial Sponsors for OSU-6162

Sponsor Name

Sponsor Name for
Sponsor Trials
Ohio State University 2
Nationwide Children's Hospital 1
VA Office of Research and Development 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Other 12
NIH 1
U.S. Fed 1
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