← Back to Search

Cannabinoid Receptor Agonist

FSD201 for Mast Cell Activation Syndrome

Phase 2
Waitlist Available
Research Sponsored by FSD Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of idiopathic MCAS as per the global consensus diagnostic criteria
Adults with widespread chronic pain (in three or more body regions)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14, day 28, day 56
Awards & highlights

Study Summary

This trial will study if a drug can reduce pain intensity in adults with chronic muscle and joint pain.

Eligible Conditions
  • Mast Cell Activation Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with MCAS based on widely accepted diagnostic criteria.
Select...
You have long-lasting pain in three or more parts of your body.
Select...
You have been experiencing moderate to severe pain for at least 6 months, which is rated between 4 and 9 on the pain scale.
Select...
You can only use acetaminophen (up to 1000 mg per dose and not more than 3000 mg per day) or diphenhydramine (up to 300 mg per day) to manage your chronic pain during the trial.
Select...
You agree to continue your regular physical activities and exercise routine during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14, day 28, day 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14, day 28, day 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Targeted treatment effect of 30% decrease from baseline to Day 28 in the average daily pain intensity
Secondary outcome measures
Change from baseline in body temperature at each in-patient visit
Change from baseline in breathing rate at each in-patient visit
Change from baseline in heart rate at each in-patient visit
+17 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FSD201Experimental Treatment1 Intervention
Participants will receive 600 milligrams (mg) FSD201 tablet twice daily (BID) orally from Day 0 to Day 56.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matched to 600 mg FSD201 tablets twice daily (BID) orally from Day 0 to Day 56.

Find a Location

Who is running the clinical trial?

FSD Pharma, Inc.Lead Sponsor
2 Previous Clinical Trials
93 Total Patients Enrolled
Andrzej Chruscinski, MDStudy DirectorFSD Pharma

Frequently Asked Questions

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

Are individuals who are twenty years of age or older eligible to participate in this trial?

"This research project is inviting adults aged between 18 and 75 to take part in the trial."

Answered by AI

Has FSD201 been validated by the FDA?

"Considering the fact that this is a Phase 2 clinical trial, which means there is evidence of safety but not efficacy, our team assigned FSD201 a score of 2 on a scale from 1 to 3."

Answered by AI

Is this research endeavor inviting participants to sign up?

"Clinicaltrials.gov reflects that this medical trial, which was made available on December 1st 2022 and lastly updated on the 8th of December, is no longer in need of participants. Fortunately, there are an abundance of other clinical trials actively recruiting patients currently."

Answered by AI

Is it feasible for me to enroll in this experiment?

"This medical trial is open to individuals between 18-75 years old who are diagnosed with mast cell activation syndrome. The maximum number of patients accepted into the study will be 60."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
What site did they apply to?
Saint Charles Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I want to help others currently facing challenges with MCAS and those who have yet to be diagnosed.
PatientReceived 1 prior treatment
~1 spots leftby Mar 2025