Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05684692
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pain, Chronic
  • Schwannomas
  • Schwannomatosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Siltuximab — DRUG
    A chimeric immunoglobulin G mAb, via intravenous infusion.
  • Erenumab-Aooe — DRUG
    Human monoclonal antibody, single-dose prefilled SureClick® autoinjector, via subcutaneous injection.
  • Siltuximab Matching Placebo — DRUG
    Dextrose 5% in water, via intravenous infusion.
  • Erenumab-Aooe Matching Placebo — DRUG
    0.9% saline, 1 mL single-dose prefilled syringe, via subcutaneous injection.

Study Details

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

Key Dates

Start date
Aug 31, 2023
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sub-study A: Siltuximab
    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).
  • Experimental: Sub-study B: Erenumab-Aooe
    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).

Primary Outcome Measure

Change in worst pain intensity for each drug sub-study [ Time Frame: Baseline to week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02215
Lauren Hibyan, RN
[email protected]
617-643-8992
Marie Aste, RN
[email protected]
617-724-2262

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By research site
Massachusetts General Hospital Cancer Center· Boston, MA

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