Research Study: An Open Label Study to Assess the Safety and Efficacy of COR-003 (2S, 4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome

Posted on November 14, 2014 by MaryO

Objectives:         

The purpose of this study is to test the effects of different doses of COR-003 on people with Cushing’s syndrome (CS) primarily by measuring the cortisol levels in urine and secondarily by measuring other health parameters such as blood pressure, weight, and liver function. This study is also being conducted to see if there is any harm caused when using COR-003.

This study is an open label study. That means both the health providers and the participants in the study are aware of the drug or treatment being given.

Eligibility:

Adult Subjects (18 years or older) with elevated levels of cortisol due to endogenous CS.

Confirmed diagnosis of persistent or recurrent CS (with or without therapy) or newly diagnosed disease, if subjects are not candidates for surgery. CS will be defined according to the criteria in the guidelines for diagnosis of CS (Nieman 2008).

Women who are pregnant or lactating are not eligible for this study.

Individuals with other health conditions or diagnoses may not be eligible for this study.

These and other eligibility criteria are best reviewed with a doctor who is participating in the study. You can also get more detailed eligibility information about the study by clicking here to visit http://www.clinicaltrials.gov.

Study Design:

  • The study will begin with a screening period to make sure subjects are eligible to participate in the study.
  • After the screening period, subjects who are eligible for participation will each be given several different doses of COR-003, to be taken orally in tablet form.
  • After an individualized dose has been selected, participants will take COR-003 for six months.
  • Finally, participants will continue in the study for an additional six months at doses to be determined by the study doctor.

 

Throughout the study, participants will meet regularly with a study doctor and will take part in a variety of medical tests to make sure they are doing well and to see if COR-003 is working.

Participants in the study should be sure they have the time to participate. Participants will generally be followed for over a year:

Study Locations

The study is currently taking place in several places around the world (United States, Belgium, France, Israel, Netherlands, Spain, and Sweden).
Additional information on the study can be found at clinicaltrials.gov through this link.

Study sponsor: Cortendo AB

For more information, please contact:

Jim Ellis at Cortendo AB tel: +1 (610) 254-9245 or jellis@cortendo.com

 

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Brains in jars at the Cushing Center in the Yale Medical Library

Posted on October 7, 2014 by MaryO

harvey-cushing-memorial

Sitting quietly in jars in a custom-built room at Yale’s medical library are 550 human brains. The collection once belonged to pioneering neurosurgeon Harvey Cushing, who preserved the brains from 1903 to 1932 as part of his tumor registry. When Cushing died in 1939, his undergraduate alma mater Yale inherited the brains.

Cushing was among a handful of doctors operating on the brain during the early 20th century. At the time, about a third of patients who underwent brain tumor surgery did not survive the operation. Cushing introduced practices that dramatically lowered the mortality rate, such as monitoring blood pressure during surgery and operating with a local anesthesic instead of ether. He was also the first to use x-rays to diagnose brain tumors.

 

Read the entire article here: Brains in jars at the Cushing Center in the Yale Medical Library.

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Could you Shed Some Light on Cushing’s Disease?

Posted on April 14, 2014 by MaryO

Dear Dr. Roach: Could you shed some light on Cushing’s disease? Four people in the same family have it. The doctors say it has something to do with the thyroid gland.

— Anon.

A: Cushing’s syndrome, which is different from Cushing’s disease, is an excess of cortisone or similar corticosteroids. It can be caused by taking too much steroid for too long, usually as treatment for a serious medical condition. Cushing’s disease is a special case of Cushing’s syndrome, when the excess cortisone is caused by a tumor in the pituitary gland, which spurs the adrenal gland to make excess amounts of hormone. Weight gain, almost exclusively in the abdomen, a striking round “moon” face, a fat pad on the back of the neck and upper back (“buffalo hump”), diabetes, pigmented stretch marks and high blood pressure are common findings in any form of Cushing’s syndrome.

It is very unusual for Cushing’s disease to run in families. Also, it does not affect the thyroid, although thyroid conditions can sometimes mimic Cushing’s (and vice versa). I suspect that what this might be is a rare condition called multiple endocrine neoplasia type I (MEN-1). This does run in families, and combines risk for pituitary, parathyroid and pancreatic islet cell tumors. (The parathyroid glands sit on top of the thyroid gland and secrete parathyroid hormone, responsible for calcium metabolism. The pancreatic islet cells are where insulin is made.) Not everybody with MEN-1 will have tumors in all of these glands. Parathyroid tumors are the most common.

An endocrinologist is the expert in Cushing’s and the MEN syndromes.

​Dr. Keith Roach writes for North America Syndicate. Send letters to Box 536475, Orlando, FL 32853-6475 or email ToYourGoodHealth@med.cornell.edu.

From http://herald-review.com/news/opinion/editorial/columnists/roach/dr-keith-roach-teeth-grinding-is-common-in-the-elderly/article_bef63ba4-9b5e-5bff-b66a-3530be158857.html

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The Role of Adrenal Scintigraphy in the Diagnosis of Subclinical Cushing’s Syndrome and the Prediction of Post-surgical Hypoadrenalism

Posted on March 25, 2014 by MaryO

World J Surg. 2014 Mar 11. [Epub ahead of print]

Ricciato MP1, Di Donna V, Perotti G, Pontecorvi A, Bellantone R, Corsello SM.

Author information

Abstract

BACKGROUND:

Management of subclinical Cushing’s syndrome (SCS) remains controversial; it is not possible to predict which patients would benefit from adrenalectomy. In the present study we aimed to evaluate the role of adrenocortical scintigraphy (ACS) in the management of patients with SCS.

METHODS:

The medical records of 33 consecutive patients with adrenal “incidentaloma” and proven or suspected SCS who underwent 131I-19-iodocholesterol ACS between 2004 and 2010 were reviewed. Sixteen underwent laparoscopic adrenalectomy (surgical group-S-group) and 17 were medically managed (medical group-M-group). Follow-up evaluation was obtained by outpatient consultation.

RESULTS:

Overall 25 patients (15 in the S-group and 10 in the M-group) had concordant unilateral uptake at ACS (ACS+). In the S-group, the mean follow-up duration was 30.9 ± 16.1 months and, irrespective of the presence of hormonal diagnosis of SCS, in patients who were ACS+ adrenalectomy resulted in a significant increase in HDL cholesterol and decreases in body mass index, glycemia, and blood pressure (BP). One patient reduced antihypertensive medication and three others were able to discontinue it altogether. Prolonged postoperative hypoadrenalism (PH) occurred in 14 patients in the S-group. The overall accuracy in predicting PH was 93.7 % for ACS and 68.7 % for laboratory findings. In the M-group, the mean follow-up duration was 31.5 ± 26.3 months and no patient developed overt Cushing’s syndrome, although ACS+ patients experienced a worsening in glycemia and diastolic BP.

CONCLUSIONS:

Adrenal scintigraphy seems the most accurate diagnostic test for SCS. It is able to predict the metabolic outcome and the occurrence of PH, identifying the patients who could benefit from adrenalectomy irrespective of hormonal diagnosis.

PMID:
24615601
[PubMed – as supplied by publisher]

From http://www.ncbi.nlm.nih.gov/pubmed/24615601

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Suspected case of Cushing’s Syndrome with history of taking medicines prescribed by registered Chinese medicine practitioner

Posted on February 19, 2014 by MaryO

The Department of Health (DH) today (February 18) alerted clients who have consulted a registered Chinese medicine practitioner (CMP) Mr Chan Kong-kin (CMP Chan), practising at G/F, No.25, Leung Tin Village in Tuen Mun, should consult health-care professionals for advice if they have been supplied with medicines suspected to be Western medicines.

The appeal followed the DH’s investigation into two public complaints. The first complaint involved a 23-year-old woman who consulted CMP Chan for management of eczema. She was given a type of green pills, two types of yellow pills and a type of red-yellow capsules for treatment of her disease for about one year.

She developed round face and increased facial hair which are features compatible with Cushing’s syndrome and steroid overdose can cause the syndrome. The patient was admitted to a public hospital on February 5 for investigation and was discharged on February 7.

The second complaint involved a 24-year-old woman who was recommended by the first complainant to consult CMP Chan for management of allergic rhinitis and eczema. She was given similar medicines as those for the first complainant for three days.

Her condition was stable.

Today, chemical analysis by the Government Laboratory on the patients’ drug samples showed that Western medicine Dexamethasone was detected in the red-yellow capsule.

Dexamethasone is a potent steroid. Taking dexamethasone for a long time, especially when in substantial dosage, can cause side effects such as moon face, high blood pressure, high blood sugar, muscle atrophy, peptic ulcer and even osteoporosis.

DH has set up a hotline 2125 1133 for public enquiries related to the medicines prescribed by the CMP.

It will operate from 9am to 9pm, Monday to Friday.

“Preliminary investigation by the DH revealed that pills and capsules were found in the CMP’s premises and all have been seized for further investigation,” the spokesman said.

“In December 31, 2012, the DH announced that CMP Chan was found in possession of Part I poisons and unregistered pharmaceutical products in the same clinic which also involved medicines with steroid. The DH subsequently took enforcement action and the relevant legal proceeding is in progress.

The case has also been referred to the Chinese Medicine Council of Hong Kong for follow-up action,” the spokesman added

“On completion of our investigation, the DH will seek advice from the Department of Justice regarding possible contravention of the Pharmacy and Poisons Ordinance (Cap 138) for the illegal sale or possession of Part I poisons. According to the Ordinance, the maximum penalty for each offence is a fine of $100,000 and two years’ imprisonment. Besides, the DH will also refer this case to the Chinese Medicine Council of Hong Kong for possible disciplinary action”, the spokesman remarked.

People who have been supplied with medicines by the concerned CMP and are in doubt should consult health-care professionals as soon as possible.

They should submit the medicines to the Chinese Medicine Division of DH at 16/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, during office hours for disposal.

Source: HKSAR Government

From http://7thspace.com/headlines/453015/suspected_case_of_cushings_syndrome_with_history_of_taking_medicines_prescribed_by_registered_chinese_medicine_practitioner.html

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