Abstract

Hypothesis: The hypothesis to be tested is that Eticholandione is safe and well tolerated in patients with Prader Willi Syndrome and it decreases body weight in patients with this disorder. A.
SPECIFIC AIMS :
The aims of this study are: 1) To determine the dose and dosing schedule of etiocholanolone that will restore etiocholanolone levels in subjects with Prader-Willi syndrome (PWS) to those found in normal individuals. 2) To determine the safety of this dose with regard to adverse events, laboratory parameters, and social and family functioning over a two week period. 3) To determine the safety and efficacy of etiocholandione given in the manner developed in Steps 1 and 2 in promoting weight loss in patients with PWS over a 3 month period. The long term goal of this project is to develop the preliminary data necessary to obtain FDA approval for a longer Phase III study involving a larger group of PWS patients.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
1M01RR010710-01A1
Application #
6283040
Study Section
Project Start
1998-06-04
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
1
Fiscal Year
1998
Total Cost
Indirect Cost

  Institution

Name
State University New York Stony Brook
Department
Type
DUNS #
804878247
City
Stony Brook
State
NY
Country
United States
Zip Code
11794

  Publications

Lima, Fabio V; Gruberg, Luis; Aslam, Usman et al. (2018) The impact of unfractionated heparin or bivalirudin on patients with stable coronary artery disease undergoing percutaneous coronary intervention. J Interv Cardiol 31:177-184
Cornelius, Talea; Birk, Jeffrey L; Edmondson, Donald et al. (2018) The joint influence of emotional reactivity and social interaction quality on cardiovascular responses to daily social interactions in working adults. J Psychosom Res 108:70-77
Edmondson, Donald; Sumner, Jennifer A; Kronish, Ian M et al. (2018) The Association of Posttraumatic Stress Disorder With Clinic and Ambulatory Blood Pressure in Healthy Adults. Psychosom Med 80:55-61
Parisette-Sparks, Alyssa; Bufferd, Sara J; Klein, Daniel N (2017) Parental Predictors of Children's Shame and Guilt at Age 6 in a Multimethod, Longitudinal Study. J Clin Child Adolesc Psychol 46:721-731
Barrios, Chelsey S; Bufferd, Sara J; Klein, Daniel N et al. (2017) The interaction between parenting and children's cortisol reactivity at age 3 predicts increases in children's internalizing and externalizing symptoms at age 6. Dev Psychopathol 29:1319-1331
Farmer, Cristan A; Epstein, Jeffery N; Findling, Robert L et al. (2017) Risperidone Added to Psychostimulant in Children with Severe Aggression and Attention-Deficit/Hyperactivity Disorder: Lack of Effect on Attention and Short-Term Memory. J Child Adolesc Psychopharmacol 27:117-124
Findling, Robert L; Townsend, Lisa; Brown, Nicole V et al. (2017) The Treatment of Severe Childhood Aggression Study: 12 Weeks of Extended, Blinded Treatment in Clinical Responders. J Child Adolesc Psychopharmacol 27:52-65
Wang, Y Claire; Shimbo, Daichi; Muntner, Paul et al. (2017) Prevalence of Masked Hypertension Among US Adults With Nonelevated Clinic Blood Pressure. Am J Epidemiol 185:194-202
Jurgens, Corrine Y; Lee, Christopher S; Riegel, Barbara (2017) Psychometric Analysis of the Heart Failure Somatic Perception Scale as a Measure of Patient Symptom Perception. J Cardiovasc Nurs 32:140-147
Gadow, Kenneth D; Brown, Nicole V; Arnold, L Eugene et al. (2016) Severely Aggressive Children Receiving Stimulant Medication Versus Stimulant and Risperidone: 12-Month Follow-Up of the TOSCA Trial. J Am Acad Child Adolesc Psychiatry 55:469-78

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