Oral Treprostinil for Raynaud's Phenomenon
This study is testing an oral medication called treprostinil (UT-15C) sustained release tablets for people with Raynaud's phenomenon (RP). RP is a condition where blood vessels in your fingers and toes narrow when cold or stressed, causing color changes, pain, and numbness. This study is for people whose RP is not getting better with usual treatments. You could join if you are 18 or older and have at least four RP attacks per week. The study aims to see if treprostinil can reduce the severity of your RP symptoms, measured by changes in your Raynaud's Condition Score over 38 weeks. The current status of this study is unclear.
- Study design
- This is an open-label study, meaning both you and the study team will know you are receiving treprostinil. It plans to enroll 30 participants.
- What's involved
- Before starting treatment, you will record your RP attacks and their duration daily for 42 days. The study will then measure your symptoms over 38 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 38 weeks, indicating follow-up for at least that duration after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Open Label Treprostinil Raynaud's Study
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Aaron B Waxman, MD, PhD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital, Pulmonary Vascular Disease Program
Who to contact
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What this trial measures
- Change in the Raynaud's Condition Score from baseline (6-week run in), comparing treprostinil treatment phase vs. baseline phase.38 weeks
Once enrolled, throughout the study (6-weeks before active treatment; 6-week titration; 26-week treatment phase) subjects will record each day the number of RP attacks as well as the duration of each RP attack.. Frequency and duration of RP recorded within 6-weeks before active treatment phase will be considered to be baseline data. Every day subjects will complete the Raynaud's Condition Score (RCS). The RCS is an 11-point numerical rating scale (0-10) where 0 = "no difficulty" and 10 = "extreme difficulty". Patients complete the scale daily, and the average scores are calculated. The scale asks patients to consider multiple factors when rating their difficulty, including the number and duration of Raynaud's attacks, symptoms such as pain, numbness, burning, and tingling, and how the condition affects their ability to use their hands and perform daily activities.