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Trial record 1 of 1 for:    12414841 [PUBMED-IDS]
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Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism

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ClinicalTrials.gov Identifier: NCT01990560
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alice C. Levine, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mild Hypercortisolism
Intervention Drug: Mifepristone
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mifepristone
Hide Arm/Group Description Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Period Title: Overall Study
Started 8
Completed 7
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Mifepristone
Hide Arm/Group Description Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
65.5  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
3
  37.5%
Male
5
  62.5%
1.Primary Outcome
Title A1C Level
Hide Description Change in hyperglycemia assessed by HbA1c, also known as glycated hemoglobin
Time Frame Baseline, 3 months, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone
Hide Arm/Group Description:
Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: percentage of red blood cells
Baseline 6.2  (0.58)
3 months 6.1375  (0.49)
6 months 6.125  (0.72)
2.Primary Outcome
Title HOMA-IR
Hide Description Change in hyperglycemia assessed by Homeostatic Model Assessment of Insulin Resistance, HOMA-IR (a validated assessment of insulin resistance). HOMA-IR = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
one participant on insulin. another participant had data missing at 6 months.
Arm/Group Title Mifepristone
Hide Arm/Group Description:
Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: HOMA-IR score
Baseline 2.418  (1.64)
6 months 1.465  (1.19)
3.Secondary Outcome
Title Waist Circumference
Hide Description Change in metabolic syndrome as assessed by waist circumference
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone
Hide Arm/Group Description:
Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: cm
Baseline 103.25  (17.43)
6 months 99.3125  (101.25)
4.Secondary Outcome
Title Body Mass Index (BMI)
Hide Description Change in metabolic syndrome as assessed by BMI
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone
Hide Arm/Group Description:
Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: kg/m2
Baseline 35.1538  (15.02)
6 months 34.5463  (15.84)
5.Secondary Outcome
Title Fasting Lipid Profile
Hide Description Change in metabolic syndrome as assessed by fasting lipid profile which includes Low-density lipoproteins ( LDL), High-density lipoproteins (HDL), and Triglycerides (Trigs) levels, and total cholesterol which is the sum of HDL plus LDL and 20% of trigs.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
one participant data missing at 6 month
Arm/Group Title Mifepristone
Hide Arm/Group Description:
Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mg/dL
Total Cholesterol Baseline Number Analyzed 8 participants
178.63  (31.35)
Total Cholesterol 6 months Number Analyzed 7 participants
171.43  (54.62)
LDL baseline Number Analyzed 8 participants
97.88  (22.34)
LDL 6 months Number Analyzed 7 participants
104.37  (44.69)
HDL Baseline Number Analyzed 8 participants
59.13  (19.50)
HDL 6 months Number Analyzed 7 participants
46.86  (14.26)
Trigs Baseline Number Analyzed 8 participants
107.88  (43.90)
Trigs 6 months Number Analyzed 7 participants
100.29  (20.21)
6.Secondary Outcome
Title Weight
Hide Description Change in metabolic syndrome as assessed by weight
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
one participant had data missing at 6 months
Arm/Group Title Mifepristone
Hide Arm/Group Description:
Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: kg
Baseline Number Analyzed 8 participants
99.57  (38.68)
6 months Number Analyzed 7 participants
97.75  (41.15)
7.Secondary Outcome
Title CushingQoL
Hide Description Change in Quality of Life - as assessed by the Cushing’s Quality of Life questionnaire (CushingQoL). Patient completed questionnaire, 12 items, each scored on a 5 point score, resulting in a score of 12 (worst) to 60 (best) where higher scores indicate more favorable QOL.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone
Hide Arm/Group Description:
Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 37.2857  (9.86)
6 months 38.7857  (10.20)
8.Secondary Outcome
Title Nottingham Health Profile (NHP)
Hide Description Change in Quality of Life as assessed by the Nottingham Health Profile (NHP) which is a patient reported questionnaire to measure a patient's view of their own health status. There are 6 sections (Energy level, Pain, Emotional Reaction, Sleep, Social Isolation, and Physical Abilities. All questions have only yes/no answer options and each section score is weighted so that the possible score range for any section is 0-100. The higher the score, the greater the number and severity of problems.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone
Hide Arm/Group Description:
Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Overall Number of Participants Analyzed 7
Mean (Inter-Quartile Range)
Unit of Measure: units on a scale
Energy Level (EL) Baseline
32.60
(0 to 38)
EL 6 months
45.40
(18 to 72.4)
Pain (P) Baseline
24.88
(0 to 25.1)
P 6 months
32.08
(0 to 44.5)
Emotional Reaction (ER) Baseline
27.03
(0 to 38.7)
ER 6 months
35.09
(7.3 to 54.6)
Sleep (S) Baseline
24.87
(5.4 to 38.8)
S 6 months
31.15
(0 to 46.3)
Social Isolation (SI) Baseline
20.09
(0 to 21)
SI 6 months
31.15
(0 to 46.29)
Physical Abilities (PA) Baseline
23.06
(0 to 48.2)
PA 6 months
27.49
(17.6 to 42.2)
9.Secondary Outcome
Title Hospital Anxiety and Depression Scale (HADS)
Hide Description Change in Quality of Life as assessed by the Hospital Anxiety and Depression Scale (HADS). Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone
Hide Arm/Group Description:
Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 16.2857  (10.90)
6 months 11.1667  (8.23)
10.Secondary Outcome
Title Quality of Life
Hide Description Change in Quality of Life as assessed by the Beck Depression Inventory. a 21-question multiple choice, self-report inventory that is used for measuring the severity of anxiety. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe anxiety symptoms.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone
Hide Arm/Group Description:
Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 16.1429  (10.32)
6 months 11.7143  (11.70)
11.Secondary Outcome
Title State Trait Anxiety Inventory (STAI)
Hide Description Change in Quality of Life - as assessed by the State Trait Anxiety Inventory (STAI). The State-Trait Anxiety Inventory both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored and averaged. Total scores range from 20 to 80, with higher scores correlating with greater anxiety.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone
Hide Arm/Group Description:
Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 25.4286  (17.61)
6 months 28.8571  (10.92)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mifepristone
Hide Arm/Group Description Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
All-Cause Mortality
Mifepristone
Affected / at Risk (%)
Total   0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Mifepristone
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mifepristone
Affected / at Risk (%) # Events
Total   2/8 (25.00%)    
Metabolism and nutrition disorders   
Hypokalemia  1/8 (12.50%)  1
Skin and subcutaneous tissue disorders   
Drug Rash  1/8 (12.50%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Alice C. Levine
Organization: Ichan School of Medicine at Mount Sinai
Phone: 212-241-1500
EMail: alice.levine@mountsinai.org
Publications:
Layout table for additonal information
Responsible Party: Alice C. Levine, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01990560     History of Changes
Other Study ID Numbers: GCO 13-1061
First Submitted: November 15, 2013
First Posted: November 21, 2013
Results First Submitted: October 18, 2017
Results First Posted: March 2, 2018
Last Update Posted: March 2, 2018