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mTOR inhibitor

Treatment Arm for Lymphangioleiomyomatosis (RESULT Trial)

Phase 2

Waitlist Available

Led By Nishant Gupta, MD

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 8, week 16, week 24

Awards & highlights

RESULT Trial 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.

RESULT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 8, week 16, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 8, week 16, week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8, week 16, week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change in Forced Expiratory Volume in One-second (FEV1) After 24 Weeks of Combined Treatment With Resveratrol and Sirolimus

EuroQOL Visual Analogue Scale (EQ-5D) Scores After Treatment With 24 Weeks of Sirolimus and Resveratrol.

Number of Treatment-Emergent Adverse Events

+3 more

RESULT Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment2 Interventions

Resveratrol 250mg daily for the first 8 weeks, followed by 250mg twice daily for the next 8 weeks, and then 500mg twice daily for the last 8 weeks. Patients will be on a stable background therapy of sirolimus prior to enrolling and will continue on that regimen throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sirolimus

FDA approved

Resveratrol

Not yet FDA approved

Do I qualify?Apply below to find out

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,837 Previous Clinical Trials

47,851,569 Total Patients Enrolled

12 Trials studying Lymphangioleiomyomatosis

3,408 Patients Enrolled for Lymphangioleiomyomatosis

University of CincinnatiLead Sponsor

428 Previous Clinical Trials

634,369 Total Patients Enrolled

6 Trials studying Lymphangioleiomyomatosis

803 Patients Enrolled for Lymphangioleiomyomatosis

Nishant Gupta, MDPrincipal InvestigatorUniversity of Cincinnati

2 Previous Clinical Trials

136 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the treatments in this clinical trial FDA approved?

"Treatment Arm is currently at a Phase 2 in terms of clinical data, meaning that while there are some studies supporting its safety, none have been done to test efficacy. Our analysts gave it a score of 2."

Answered by AI

What illnesses does Treatment Arm usually help to improve?

"Treatment Arm can help patients that have been rejected for a transplant, are struggling with liver disease, or have kidney issues."

Answered by AI

Are there other research studies that have used a similar treatment protocol to the one being proposed?

"At the moment, 134 clinical trials are underway to research Treatment Arm. Of these active studies, 14 have reached Phase 3 status. The majority of research centres for Treatment Arm are located in Cincinnati, Ohio; though, there are 1088 total locations running these types of experiments."

Answered by AI

How many people are allowed to join this trial?

"Recruitment for this study has ended. It was originally posted on March 31st, 2018 and edited last on October 20th, 2022. If you are seeking other studies, there are 7 clinical trials recruiting patients with lymphangioleiomyomatosis and 134 Treatment Arm studies looking for patients."

Answered by AI

Are people with the relevant medical conditions able to sign up for this trial today?

"The clinical trial described is not presently looking for patients, however this could change in the future. According to the data on clinicaltrials.gov, The study was originally posted on 3/31/2018 and was last edited on 10/20/2022. Currently, there are 141 other studies that are accepting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial

Nishant Gupta, MD, MS 2018. "Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03253913.