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SPI-62 for Cushing's Syndrome (RESCUE Trial)

Phase 2
Waitlist Available
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.
Must not have
Recent (within 6 weeks) surgery for Cushing's or surgery planned within 24 weeks of randomization.
History of bilateral adrenalectomy or exogenous, pseudo, cyclic, or non-ACTH-dependent Cushing's syndrome (including certain inherited conditions).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 24 weeks of treatment

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with ACTH-dependent Cushing's syndrome.
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I am a man or a woman who does not have periods.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had or will have surgery for Cushing's disease within 6 months.
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I have a history of specific adrenal gland surgery or rare forms of Cushing's syndrome.
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I have not had radiation for Cushing's in the last 2 or 4 years.
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I am not pregnant, breastfeeding, or planning to become pregnant and agree to use birth control or abstain.
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My tumor is large and may press on important body parts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 24 weeks of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 24 weeks of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in urinary HSD-1 ratio
Secondary study objectives
Treatment emergent adverse events

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
SPI-62
2021
Completed Phase 1
~20
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Sparrow PharmaceuticalsLead Sponsor
4 Previous Clinical Trials
138 Total Patients Enrolled
Frank Czerwiec, MDStudy DirectorSparrow Pharmaceuticals (info@sparrowpharma.com)
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

SPI-62 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05307328 — Phase 2
Cushing's Syndrome Research Study Groups: SPI-62, Placebo
Cushing's Syndrome Clinical Trial 2023: SPI-62 Highlights & Side Effects. Trial Name: NCT05307328 — Phase 2
SPI-62 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05307328 — Phase 2
~0 spots leftby Dec 2024
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