Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial (NCT03253913) | Clinical Trial Compass
CompletedPhase 2
Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial
United States25 participantsStarted 2018-03-31
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Definitive diagnosis LAM based on the presence of characteristic cystic change on high-resolution computed tomography (HRCT) of the chest. The diagnosis must be confirmed by one of the following:
✓. Age 18 years or greater.
✓. Signed and dated informed consent
✓. Currently on sirolimus for treatment of LAM for at least 20 weeks
✓. Evidence of disease stabilization on sirolimus as demonstrated by two stable values of serum VEGF-D post initiation of sirolimus drawn at least 12 weeks apart from each other. For the purpose of this study, a variation in serum VEGF-D of less than or equal to 15% is considered stable.
Exclusion criteria
✕. Known allergy or hypersensitivity to Resveratrol
✕. Inability to provide informed consent
✕. Active enrollment in other clinical drug trials for LAM
✕. Pregnant or plan to become pregnant in the next 6 months
What they're measuring
1
Serum Vascular Endothelial Growth Factor-D (VEGF-D) Levels After Treatment With a Combination of Resveratrol and Sirolimus as Compared to Baseline Serum VEGF-D Levels on Sirolimus Alone