← Back to Search

Monoclonal Antibodies

Erenumab + Siltuximab for Schwannomatosis Pain

Phase 2

Recruiting

Led By Scott Plotkin, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Patients must have a confirmed diagnosis schwannomatosis by fulfilling either clinical or molecular diagnosis.

Two or more non-intradermal schwannomas, one with pathological confirmation, without evidence of bilateral vestibular schwannoma (see

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization/1st treatment to 4 weeks post final treatment

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of two different treatments for pain caused by schwannomatosis.

Who is the study for?

This trial is for people with schwannomatosis, a condition causing chronic pain due to tumors on nerves. Participants must have at least two non-skin surface tumors, one confirmed by pathology, and no signs of certain other nerve-related tumors.Check my eligibility

What is being tested?

The STARFISH trial is testing the safety and pain relief effectiveness of Erenumab-Aooe and Siltuximab against placebos in individuals with schwannomatosis. It's a phase II study where patients are randomly assigned to receive either an experimental therapy or a placebo.See study design

What are the potential side effects?

Possible side effects from Erenumab-Aooe may include injection site reactions, constipation, muscle spasms, and possibly others. Siltuximab could cause rash, upper respiratory infections, swelling in limbs or face among other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with schwannomatosis.

Select...

I have two or more schwannomas, one confirmed by a doctor, and no bilateral vestibular schwannoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization/1st treatment to 4 weeks post final treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization/1st treatment to 4 weeks post final treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization/1st treatment to 4 weeks post final treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in worst pain intensity for each drug sub-study

Secondary outcome measures

Number of Participants with Adverse Events in each drug sub-study

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sub-study B: Erenumab-AooeExperimental Treatment2 Interventions

The treatment period includes a single-blind treatment period (days 1-84) and an open-label treatment period (days 85-168). All participants will receive erenumab-aooe during this drug sub-study. Twenty (20) participants will receive a randomization assignment to receive either Erenumab-Aooe or matching placebo during the single-blind treatment period. All participants will receive erenumab-aooe during the open-label treatment period. Participants will complete study procedures as outlined: Single-Blind treatment period (days 1 - 84): Administration of Erenumab-Aooe versus matching placebo in pre-determined dose once every 28 days (for 3 cycles). Open-Label Treatment period (days 85-168): Administration of Erenumab-Aooe in pre-determined dose once every 28 days (for 3 cycles).

Group II: Sub-study A: SiltuximabExperimental Treatment2 Interventions

The treatment period includes a double-blind treatment period (days 1-84) and an open-label treatment period (days 85-168). All participants will receive siltuximab during this drug sub-study. Twenty (20) participants will be randomized to receive either Siltuximab or matching placebo during the double-blind treatment period. All participants will receive siltuximab during the open-label treatment period. Participants will complete study procedures as outlined: Double-Blind Treatment period: Administration of Siltuximab versus matching placebo in pre-determined dose once every 21 days (for 4 cycles). Open-Label Treatment period: Administration of Siltuximab in pre-determined dose once every 21 days (for 4 cycles).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Siltuximab

2011

Completed Phase 3

~1190

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,941 Previous Clinical Trials

13,200,628 Total Patients Enrolled

3 Trials studying Schwannomatosis

298 Patients Enrolled for Schwannomatosis

United States Department of DefenseFED

866 Previous Clinical Trials

327,465 Total Patients Enrolled

Recordati Rare DiseasesIndustry Sponsor

10 Previous Clinical Trials

427 Total Patients Enrolled

Media Library

Erenumab-Aooe (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05684692 — Phase 2

Schwannomatosis Research Study Groups: Sub-study B: Erenumab-Aooe, Sub-study A: Siltuximab

Schwannomatosis Clinical Trial 2023: Erenumab-Aooe Highlights & Side Effects. Trial Name: NCT05684692 — Phase 2

Erenumab-Aooe (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05684692 — Phase 2

Frequently Asked Questions

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

Has Siltuximab been granted regulatory clearance by the FDA?

"Our experts rated Sub-study A: Siltuximab's safety at a 2 due to the existence of Phase 2 trials, indicating some data exists which addresses its security but not efficacy."

Answered by AI

Is enrollment for this research project still taking place?

"According to the information on clinicaltrials.gov, this medical study is not in a recruiting phase at present. Initially posted on March 1st 2023 and updated most recently on January 5th 2023, it has yet to actively seek out participants - although 621 other trials are currently doing so."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

Scott R. Plotkin, MD, PhD 2023. "Screening Trial for Pain Relief in Schwannomatosis (STARFISH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05684692.

All > Schwannomatosis > Neurofibromatosis