Clinical Trials Logo

Clinical Trial 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


Clinical Trial Description

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). The MASTER STUDY has no study drug or intervention. It is intended to enroll participants who will be placed into different treatment arms (SUB-STUDIES), which will each have an additional consent and enrollment process. MASTER STUDY - The research study procedures include screening for eligibility, randomization to an experimental treatment sub-study, if qualified, and observation for up to 10 years. - Subjects who complete treatment on one experimental arm will be permitted to enroll in a different experimental treatment arm if they meet eligibility criteria. - Participants who are not eligible for enrollment in a different treatment sub-study will be permitted to remain under observation on this Master Study to understand the natural history of schwannomatosis-related pain and tumor growth pattern. - Participants will be eligible to remain on this Master Study for up to 10 years. - It is expected that about 40 people will take part in the Master Study. - The study will randomize a maximum of 20 participants to each of the experimental arms. The overall size of the trial is not fixed by design because it includes arm-dropping rules for futility and allow for the possibility of arm addition by amendment. - Upon meeting Master Study qualifications, participant will be randomly assigned to a treatment sub-study. SUB-STUDY A - SILTUXIMAB - The purpose of this study is to find out what effects, good and/or bad, siltuximab has on schwannomatosis-associated pain. - The U.S. Food and Drug Administration (FDA) has not approved Siltuximab for schwannomatosis but it has been approved for the treatment of people with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. - Siltuximab was identified as a potential treatment for schwannomatosis tumors in a screen of compounds in a laboratory. Siltuximab is believed to work by blocking the growth signals and inflammation in tumor cells. - Upon meeting sub-study qualifications, participant will be randomly assigned to either the early-start group or the delayed-start group. - Twenty (20) people will take part in the siltuximab Sub-study. - Participants in the early-start group will receive siltuximab every 3 weeks over 168 days. Participants in the delayed-start group will receive placebo every 3 weeks for the first 84 days followed by siltuximab every 3 weeks over the subsequent 84 days (for a total of 168 days). SUB-STUDY B - ERENUMAB-AOOE - The purpose of this study is to find out what effects, good and/or bad, erenumabaooe has on schwannomatosis-associated pain. - The U.S. Food and Drug Administration (FDA) has not approved Erenumab-Aooe for schwannomatosis but has approved it for treatment of migraines headaches in adults. - Erenumab-Aooe was identified as a potential treatment for schwannomatosis pain. Erenumab-aooe acts by blocking pain signals in the body. By blocking pain signals, erenumabaooe may reduce pain associated with schwannomatosis. - Upon meeting sub-study qualifications, participant will be randomly assigned to either the early-start group or the delayed-start group. - Twenty (20) people will take part in the ERENUMAB-AOOE Sub-study. - Participants in the early-start group will receive erenumab-aooe every 4 weeks over 168 days. Participants in the delayed-start group will receive placebo every 4 weeks for the first 84 days followed by erenumab-aooe every 4 weeks over the subsequent 84 days (for a total of 168 days). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05684692
Study type Interventional
Source Massachusetts General Hospital
Contact Scott Plotkin, MD, PhD
Phone 617-643-8992
Email lmhibyan@partners.org
Status Recruiting
Phase Phase 2
Start date August 31, 2023
Completion date November 30, 2027

See also
  Status Clinical Trial Phase
Completed NCT05452499 - Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae N/A
Recruiting NCT05037682 - Pain and Opioid Management in Older Adults N/A
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Recruiting NCT05382962 - iCanCope With Post-Operative Pain (iCanCope PostOp) N/A
Recruiting NCT04285112 - SPRINT: Signature for Pain Recovery IN Teens
Active, not recruiting NCT04850079 - EHR Precision Drug Treatment in Neonates
Completed NCT03271151 - Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty Phase 4
Completed NCT03272139 - Interscalene Block Versus Superior Trunk Block Phase 4
Completed NCT03886142 - Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis N/A
Recruiting NCT05761392 - APP-based Precise Management System of Chronic Intractable Pain N/A
Recruiting NCT05877157 - Pain AND Opioids After Surgery
Completed NCT03947749 - Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain
Completed NCT03280017 - Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain Phase 4
Recruiting NCT04874038 - Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN) Phase 3
Completed NCT04280796 - Changes in Affective Pain Processing in Human Volunteers N/A
Withdrawn NCT05125978 - Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain Phase 2
Not yet recruiting NCT04328805 - Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome. Phase 4
Completed NCT04976738 - A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain Phase 1/Phase 2
Completed NCT04089618 - Meditation Based Lifestyle Modification in Chronic Pain N/A
Recruiting NCT05699837 - Alpha Entrainment for Pain and Sleep (Extension) N/A