Actively Recruiting
Open Label Treprostinil Raynaud's Study
Led by Brigham and Women's Hospital · Updated on 2026-03-24
30
Participants Needed
2
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Raynaud's phenomenon is a condition where the blood vessels in participants fingers and toes get too narrow when cold or stressed. This makes participants fingers and toes change colors - they might turn white, then blue, and finally red as blood flow returns. It can be painful and cause numbness or tingling. When participants have Raynaud's, blood vessels react too strongly to cold or stress. Fingers and toes may turn white (blood moves away from the area), blue (lack of oxygen), or red and feel painful or tingly when warming up. These episodes usually last from a few minutes to several hours. There are two types of Raynaud's. Primary Raynaud's (also called Raynaud's disease) itself and isn't connected to other health problems. It's the most common type and affects mostly women under 30. Secondary Raynaud's (also called Raynaud's phenomenon) is caused by other diseases like lupus, scleroderma, or rheumatoid arthritis. This type tends to be more serious and may cause painful sores on fingertips called digital ulcers. For mild cases, staying warm might be enough. But if symptoms are severe, participants doctor might prescribe various medications including calcium channel blockers - blood pressure medicines that help open blood vessels, or other vasodilators - medicines that widen blood vessels. About 40% of people with scleroderma develop painful sores on their fingertips called digital ulcers. These happen when there isn't enough blood flow to heal small injuries. For severe cases with digital ulcers, doctors might use prostacyclin therapy - medicines that mimic a natural substance that opens blood vessels. Oral treprostinil is a newer pill form of prostacyclin therapy that helps improve blood flow. The investigators are conducting a research study testing whether oral treprostinil - a pill that mimics prostacyclin (a natural blood vessel opener) - can help people with severe Raynaud's that doesn't respond to usual treatments. This represents hope for better treatment options for people with the most challenging cases of this condition.
CONDITIONS
Official Title
Open Label Treprostinil Raynaud's Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Active Raynaud's Phenomenon with four or more attacks per week in the 4 weeks before joining
- Diagnosis of either primary Raynaud's Phenomenon or Raynaud's secondary to connective tissue diseases such as scleroderma, CREST, mixed connective tissue disease, primary Sjogren's syndrome, or systemic lupus erythematosus
- Stable doses for at least 3 months of phosphodiesterase inhibitors, endothelin antagonists, alpha adrenergic antagonists, or calcium channel blockers if currently used
- Female participants of childbearing potential must have a negative pregnancy test and agree to contraceptive requirements
- Female participants not of childbearing potential must be postmenopausal or have surgical sterilization documented
You will not qualify if you...
- Uncontrolled high blood pressure, diabetes, recent heart or brain event within 3 months, or history of sympathectomy
- Smoking or use of nicotine products within 3 months
- History of alcohol or substance abuse in the past year
- Diverticulosis with at least three diverticula confirmed by colonoscopy
- Moderate to severe liver disease (Child Pugh Class B or C)
- Current use of any other prostacyclin medication
- Pregnant, breastfeeding, or planning pregnancy within 4 months
- Participation in another investigational drug or therapy trial within 30 days or 5 half-lives before screening
- Serious or unstable medical, surgical, or psychiatric conditions that could affect safety or study compliance
- Hospitalization for any reason within 7 days before screening start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115-6110
Not Yet Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
O
Olivia G Vayer
CONTACT
R
Ruth Marrero
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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