At a glance
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Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial (RESULT)
In Brief
A Phase 2 clinical trial evaluating Sirolimus and Resveratrol for Lymphangioleiomyomatosis. Completed, enrolled 25 participants across 1 site.
Detailed Summary
RESULT is a phase II dose-escalating, open-label, safety and efficacy study to determine if there is a potential benefit of resveratrol in combination with sirolimus in patients with lymphangioleiomyomatosis (LAM). The primary study objective is to assess the change in serum vascular endothelial growth factor-D (VEGF-D) level after 24 weeks of treatment with a combination of resveratrol and sirolimus as compared to the VEGF-D level in patients on a stable dose of sirolimus alone. The secondary objectives of this study include an assessment of the safety and adverse effect profile of combined resveratrol and sirolimus in adult patients with LAM, and to determine the effect of treatment with a combination of resveratrol and sirolimus on changes in lung function and quality of life.
Study Details
Timeline
Interventions
Patients will have been on a stable dose of sirolimus prior to enrolling and will continue that throughout the study.
Escalating doses of resveratrol will be given throughout the study. Patients will start at 250mg daily for 8 weeks, followed by 500mg daily for 8 weeks, and 500mg BID for the last 8 weeks.