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SPI-62 for Cushing's Syndrome (RESCUE Trial)
Phase 2
Recruiting
Research Sponsored by Sparrow Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years or older
Documented diagnosis of ACTH-dependent Cushing's syndrome including Cushing's disease, ectopic ACTH secretion, and ectopic CRH secretion.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 24 weeks of treatment
Awards & highlights
RESCUE Trial Summary
This trial is testing SPI-62, a possible treatment for Cushing's syndrome, in a group of people with the condition. The study includes a placebo group for comparison.
Who is the study for?
This trial is for adults over 18 with ACTH-dependent Cushing's syndrome not caused by an adrenal tumor. Participants must have consistent cortisol excess and a confirmed diagnosis. They can't join if they've had recent Cushing's surgery, are at risk of tumor growth complications, have conditions that could affect the study, are pregnant or not using contraception, or have had certain past treatments for Cushing's.Check my eligibility
What is being tested?
The study tests SPI-62 against a placebo in patients with ACTH-dependent Cushing's syndrome. Each participant will receive both SPI-62 and a placebo for 24 weeks each, with an option to continue longer. The assignment to either SPI-62 or placebo is random.See study design
What are the potential side effects?
While specific side effects of SPI-62 aren't listed here, clinical trials may monitor for common drug-related issues like nausea, headaches, dizziness, allergic reactions or more serious concerns depending on how the drug works.
RESCUE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with ACTH-dependent Cushing's syndrome.
Select...
I am a man or a woman who does not have periods.
RESCUE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through 24 weeks of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 24 weeks of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in urinary HSD-1 ratio
Secondary outcome measures
Treatment emergent adverse events
RESCUE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SPI-62Experimental Treatment2 Interventions
Active drug by mouth each morning for up to 12 weeks
Group II: PlaceboPlacebo Group2 Interventions
Placebo by mouth each morning for up to 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Sparrow PharmaceuticalsLead Sponsor
4 Previous Clinical Trials
234 Total Patients Enrolled
Frank Czerwiec, MDStudy DirectorSparrow Pharmaceuticals (info@sparrowpharma.com)
1 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any health issues that would affect this study's process or results.You have ongoing high levels of cortisol in your body.I have had or will have surgery for Cushing's disease within 6 months.I have a history of specific adrenal gland surgery or rare forms of Cushing's syndrome.I am 18 years old or older.I have been diagnosed with ACTH-dependent Cushing's syndrome.I have not had radiation for Cushing's in the last 2 or 4 years.I am not pregnant, breastfeeding, or planning to become pregnant and agree to use birth control or abstain.My tumor is large and may press on important body parts.I am a man or a woman who does not have periods.
Research Study Groups:
This trial has the following groups:- Group 1: SPI-62
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled vacancies in this research project?
"According to the information available on clinicaltrials.gov, this study is still recruiting patients. The listing was first made on March 1st, 2022 and the most recent update was September 21st of the same year."
Answered by AI
Could you please speak to the risks associated with SPI-62?
"SPI-62's safety is estimated to be a 2. This rating comes from the fact that it is a Phase 2 trial, so while there is data indicating that SPI-62 is safe, there is no clinical evidence yet demonstrating its efficacy."
Answered by AI
How many different sites are participating in this trial?
"Patients can be enrolled at UCLA in Los Angeles, California; St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - Pituitary Center in Phoenix, Arizona; Mayo Clinic Cancer Center (MCCC) - Rochester in Rochester, Minnesota; as well as 11 other locations."
Answered by AI
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