Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07112183 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Open Label Treprostinil Raynaud's Study

StatusRecruiting
PhasePhase 4
Started2025-10-15
View on ClinicalTrials.gov ↗

Amendment history

2026-03-20
notable
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-08-01→confirmed 2025-10-15
Study sites1→2
Eligibility criteria+1,332 characters
Inclusion Criteria:• Patients aged ≥ 18 years Active Raynaud's Phenomenon define [...] ttacks per week in the 4 weeks before inclusion in the study despite stable background vasodilator treatment for at least 3 months. Patients with primaryeither: Primary Raynaud's Phenomenon Patients with Raynaud's secondary to c [...] he underlying rheumatic disease based on standard criteria. PatientsIf patients are on stable dose phosphodiesterase inhibitors (sildenafil, tadalafil or vard [...] s, alpha adrenergic antagonists, or calcium channel blockers, their dose must be stable, defined as 3-months with no change in dose wi [...] [...]
2025-08-07
minor
Original filing
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.
Trial Details
NCT Number NCT07112183
Lead Sponsor Brigham and Women's Hospital
Conditions Raynaud's Disease, Raynaud Phenomena, Raynauds
Enrollment 30 participants
Start Date 2025-10-15
Primary Completion 2028-09-30 (estimated)
Study Completion 2029-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-24