RecruitingPhase 2NCT05684692

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)


Sponsor

Massachusetts General Hospital

Enrollment

40 participants

Start Date

Aug 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN). This Master Study is being conducted as a platform that may allow participants with pain associated with schwannomatosis to receive a novel intervention throughout this study. Embedded within the Master Study are individual drug sub-studies: * Investigational Drug Sub-Study A: Siltuximab * Investigation Drug Sub-Study B: Erenumab-Aooe


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Erenumab-Aooe, a drug called Erenumab-Aooe Matching Placebo, and others for people with pain, chronic, schwannomas, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSiltuximab

A chimeric immunoglobulin G mAb, via intravenous infusion.

DRUGErenumab-Aooe

Human monoclonal antibody, single-dose prefilled SureClick® autoinjector, via subcutaneous injection.

DRUGSiltuximab Matching Placebo

Dextrose 5% in water, via intravenous infusion.

DRUGErenumab-Aooe Matching Placebo

0.9% saline, 1 mL single-dose prefilled syringe, via subcutaneous injection.


Locations(1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

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NCT05684692


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