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SPI-62 for Cushing's Syndrome (ACSPIRE 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
Documented characteristically benign adrenal nodule, with diameter ≤ 4 cm, homogenous texture, and non-contrast computerized tomography ≤ 20 HU attenuation or proven to be non malignant
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights
ACSPIRE Trial Summary
This trial will study whether SPI-62 is an effective, safe treatment for hypercortisolism caused by a benign adrenal tumor.
Who is the study for?
This trial is for adults with a benign adrenal tumor causing high cortisol levels, which may lead to conditions like diabetes or high blood pressure. Participants should have stable health conditions and not be pregnant, lactating, or have had recent major surgery. They shouldn't have other forms of Cushing's syndrome or certain cancers within the last 3 years.Check my eligibility
What is being tested?
The study tests SPI-62 at various doses to see if it can safely treat hypercortisolism due to a benign adrenal tumor. Each participant will take a daily dose of SPI-62 (2mg) and their response will be monitored for effectiveness and safety.See study design
What are the potential side effects?
While specific side effects of SPI-62 are not listed here, common side effects from treatments targeting cortisol levels include fatigue, nausea, changes in blood pressure or blood sugar levels, mood swings, and increased risk of infections.
ACSPIRE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My adrenal nodule is non-cancerous, smaller than 4 cm, and has a uniform texture.
ACSPIRE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in HbA1c at Week 6
Change in HbA1c at week 12
ACSPIRE Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: SPI-62 dose 4Experimental Treatment1 Intervention
6mg dose level of SPI-62. Active drug by mouth each morning for up to 12 weeks.
Group II: SPI-62 dose 3Experimental Treatment1 Intervention
2mg dose level of SPI-62. Active drug by mouth each morning for up to 12 weeks.
Group III: SPI-62 dose 2Experimental Treatment1 Intervention
0.6mg dose level of SPI-62. Active drug by mouth each morning for up to 12 weeks.
Group IV: SPI-62 dose 1Experimental Treatment1 Intervention
0.2mg dose level of SPI-62. Active drug by mouth each morning for up to 12 weeks.
Group V: PlaceboPlacebo Group1 Intervention
Placebo by mouth each morning for up to 12 weeks.
Find a Location
Who is running the clinical trial?
Sparrow PharmaceuticalsLead Sponsor
4 Previous Clinical Trials
110 Total Patients Enrolled
Frank Czerwiec, MDStudy ChairSparrow Pharmaceuticals
1 Previous Clinical Trials
26 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I tested positive for COVID-19 within the last 4 weeks or was hospitalized for it within the last 6 months.I have high cholesterol, high triglycerides, weak bones, a history of fractures, or high blood pressure related to cortisol.My thyroid condition is not under control.I am an adult who can understand and agree to the study's details.I have been diagnosed with a condition that affects my adrenal glands or causes high cortisol levels.I have not had major surgery in the last month and do not plan any during the trial.I have diabetes or pre-diabetes with specific blood sugar levels.My adrenal nodule is non-cancerous, smaller than 4 cm, and has a uniform texture.I have high cortisol levels not caused by my body.I have a history of low platelet counts without a known cause.I haven't had cancer (except for certain skin, thyroid, or early prostate cancer) in the last 3 years.My kidney function is moderately impaired.I have had or will have surgery to remove my adrenal gland within 4 months.My body doesn't properly control cortisol levels, even after specific tests.
Research Study Groups:
This trial has the following groups:- Group 1: SPI-62 dose 1
- Group 2: Placebo
- Group 3: SPI-62 dose 3
- Group 4: SPI-62 dose 2
- Group 5: SPI-62 dose 4
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.
What is the government's stance on SPI-62 dose1?
"There is limited data supporting SPI-62 dose1's safety, but none for efficacy. Consequently, it was given a score of 2."
Answered by AI
Are people still being signed up for this experiment?
"Yes, the clinical trial is still recruiting patients. According to information on clinicaltrials.gov, the original posting was June 9th, 2022 and there have been 150 patients recruited from 19 different sites."
Answered by AI
At how many different locations is this trial currently taking place?
"Patients are currently being enrolled at 20 different locations for this study, UCLA Medicine and Simon Cancer Center among them."
Answered by AI
How many people are taking part in this clinical trial at the most?
"That is correct, the online information points to this trial actively recruiting patients. This specific study was originally posted on June 9th, 2022 and was last updated September 21st of the same year. The research team is looking for 150 individuals total at 19 different locations."
Answered by AI
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