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Safety and Efficacy of FSD201 for the Treatment of Chronic Pain Associated With Idiopathic MCAS (MCAD)

NCT05652907 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-04-21

Study results available
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Summary

This study will determine if FSD201 reduces the average daily 24-hour recall pain intensity after 28 and 56 days of treatment in adults with chronic widespread musculoskeletal nociplastic pain.

Conditions

  • Mast Cell Activation Syndrome
  • Mast Cell Activation Disorder Idiopathic

Interventions

DRUG

FSD201

Tablets for oral administration.

DRUG

Placebo

Placebo tablets matched to FSD201 for oral administration.

Sponsors & Collaborators

  • Quantum Biopharma

    lead INDUSTRY

Principal Investigators

  • Andrzej Chruscinski, MD · FSD Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-19
Primary Completion
2023-05-24
Completion
2023-05-24
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05652907 on ClinicalTrials.gov