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NCT05684692 · ClinicalTrials.gov registry record · Phase 2
Screening Trial for Pain Relief in Schwannomatosis (STARFISH)
A Phase 2 study of Pain, Chronic and Schwannomatosis, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05684692: Recruiting Phase 2 study of Pain, Chronic and Schwannomatosis, sponsored by Massachusetts General Hospital.
NCT05684692 is a Phase 2 study of Pain, Chronic and Schwannomatosis that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 40 participants, below the 721-participant average among 48 other Pain, Chronic trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05684692, a Phase 2 study of Pain, Chronic and Schwannomatosis, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Defined as the change in the worst pain intensity between baseline and day 85. Worst pain is measured using the 11-point Pain Intensity Numerical Rating Scale (NRS), where scores range from 0 (no pain) to 10 (worst pain ever) of the maximum SWN-related pain experienced over the past week
Conditions Studied
Interventions
- DRUG Siltuximab
- DRUG Erenumab-Aooe
- DRUG Siltuximab Matching Placebo
- DRUG Erenumab-Aooe Matching Placebo
Study Locations (1)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-08-31 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 2 |
What NCT05684692 shows while recruiting
NCT05684692 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 721-participant average among 48 other Pain, Chronic trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Pain, Chronic appearing as the primary indexed condition, and to 4 interventions - of which Siltuximab is the first listed.
NCT05684692 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05684692 about?
NCT05684692 is a clinical study titled "Screening Trial for Pain Relief in Schwannomatosis (STARFISH)". 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...
What is the current status of trial NCT05684692?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2023-08-31. Estimated completion is 2027-11-30.
What conditions does trial NCT05684692 study?
This clinical trial studies the following conditions: Pain, Chronic, Schwannomatosis, Schwannomas.
What interventions are being tested in trial NCT05684692?
The interventions under investigation include: Siltuximab (DRUG), Erenumab-Aooe (DRUG), Siltuximab Matching Placebo (DRUG), Erenumab-Aooe Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT05684692?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05684692 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pain, Chronic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05684692's enrollment target sits among peer trials
40 37th of 48 higher than 11 of 48 other Pain, Chronic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Chronic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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