NCT05652907 is a Phase 2 clinical trial of FSD201 in Mast Cell Activation Syndrome, sponsored by Quantum Biopharma.

Who is sponsoring NCT05652907?

NCT05652907 is sponsored by Quantum Biopharma.

What drugs are being tested in NCT05652907?

Interventions in NCT05652907: FSD201, Placebo.

What condition does NCT05652907 study?

NCT05652907 studies Mast Cell Activation Syndrome, Mast Cell Activation Disorder Idiopathic.

Is NCT05652907 still recruiting?

NCT05652907 is currently terminated. Last updated 6 July 2023.

Last reviewed 2023-07-06 · How we verify

NCT05652907

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Last updated 6 July 2023

What this trial tests

Phase 2 trial testing FSD201 in Mast Cell Activation Syndrome in 2 participants. Terminated before completion.

Timeline

19 January 2023

Primary endpoint
24 May 2023

24 May 2023

Quick facts

Lead sponsor	Quantum Biopharma
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	2
Start date	19 January 2023
Primary completion	24 May 2023
Estimated completion	24 May 2023
Sites	3 locations across Canada, United States

Drugs / interventions tested

FSD201 — full drug profile →
Placebo

Conditions studied

Mast Cell Activation Syndrome — all drugs for Mast Cell Activation Syndrome →
Mast Cell Activation Disorder Idiopathic — all drugs for Mast Cell Activation Disorder Idiopathic →

Sponsor

Quantum Biopharma — full company profile →

Who can join

Adults 18 to 75, any sex, with Mast Cell Activation Syndrome or Mast Cell Activation Disorder Idiopathic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of FSD201

Trials testing the same drug.

NCT04619706 — Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19 · Phase 2 · terminated

Other recruiting trials for Mast Cell Activation Syndrome

Currently open trials in the same condition.

NCT04806620 — Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research · recruiting

Other Quantum Biopharma trials

Trials by the same sponsor.

NCT06505239 — Assessing the Safety and Efficacy of FSD-F2R6-A-CP in Volunteers in an Induced State of Alcohol Intoxication · NA · completed
NCT05821387 — Evaluating the Safety, Tolerability, Pharmacokinetics, and Effect of Food of Lucid-21-302 in Healthy Volunteers · Phase 1 · completed
NCT04619706 — Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19 · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05652907 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Quantum Biopharma
Last refreshed: 6 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05652907.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing