Trial Outcomes & Findings for Safety and Efficacy of FSD201 for the Treatment of Chronic Pain Associated With Idiopathic MCAS (MCAD) (NCT NCT05652907)
NCT ID: NCT05652907
Last Updated: 2026-04-21
Results Overview
Targeted treatment effect of 30% decrease from baseline to Day 28 in the average daily pain intensity score measured by an 11-point numerical pain rating scale (NPRS). NPRS is an 11-point scale from 0 to10 where the higher number indicates worse pain. Averages will be calculated as follows: Baseline: calculated weekly average from Day -7 to Day -1 Day 28: calculated weekly average from Day 22 to Day 28
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Day 28
Results posted on
2026-04-21
Participant Flow
Participant milestones
| Measure |
FSD201
Participants will receive 600 milligrams (mg) FSD201 tablet twice daily (BID) orally from Day 0 to Day 56.
FSD201: Tablets for oral administration.
|
Placebo
Participants will receive placebo matched to 600 mg FSD201 tablets twice daily (BID) orally from Day 0 to Day 56.
Placebo: Placebo tablets matched to FSD201 for oral administration.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
FSD201
Participants will receive 600 milligrams (mg) FSD201 tablet twice daily (BID) orally from Day 0 to Day 56.
FSD201: Tablets for oral administration.
|
Placebo
Participants will receive placebo matched to 600 mg FSD201 tablets twice daily (BID) orally from Day 0 to Day 56.
Placebo: Placebo tablets matched to FSD201 for oral administration.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of FSD201 for the Treatment of Chronic Pain Associated With Idiopathic MCAS (MCAD)
Baseline characteristics by cohort
| Measure |
FSD201
n=1 Participants
Participants will receive 600 milligrams (mg) FSD201 tablet twice daily (BID) orally from Day 0 to Day 56.
FSD201: Tablets for oral administration.
|
Placebo
n=1 Participants
Participants will receive placebo matched to 600 mg FSD201 tablets twice daily (BID) orally from Day 0 to Day 56.
Placebo: Placebo tablets matched to FSD201 for oral administration.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=13 Participants
|
1 participants
n=13 Participants
|
2 participants
n=26 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: No participants treated with FSD201 completed the trial
Targeted treatment effect of 30% decrease from baseline to Day 28 in the average daily pain intensity score measured by an 11-point numerical pain rating scale (NPRS). NPRS is an 11-point scale from 0 to10 where the higher number indicates worse pain. Averages will be calculated as follows: Baseline: calculated weekly average from Day -7 to Day -1 Day 28: calculated weekly average from Day 22 to Day 28
Outcome measures
| Measure |
FSD201
Participants will receive 600 milligrams (mg) FSD201 tablet twice daily (BID) orally from Day 0 to Day 56.
FSD201: Tablets for oral administration.
|
Placebo
n=1 Participants
Participants will receive placebo matched to 600 mg FSD201 tablets twice daily (BID) orally from Day 0 to Day 56.
Placebo: Placebo tablets matched to FSD201 for oral administration.
|
|---|---|---|
|
Targeted Treatment Effect of 30% Decrease From Baseline to Day 28 in the Average Daily Pain Intensity
|
—
|
0 participants
|
Adverse Events
FSD201
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FSD201
n=1 participants at risk
Participants will receive 600 milligrams (mg) FSD201 tablet twice daily (BID) orally from Day 0 to Day 56.
FSD201: Tablets for oral administration.
|
Placebo
n=1 participants at risk
Participants will receive placebo matched to 600 mg FSD201 tablets twice daily (BID) orally from Day 0 to Day 56.
Placebo: Placebo tablets matched to FSD201 for oral administration.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Worsening flushing
|
100.0%
1/1 • 60 days
|
0.00%
0/1 • 60 days
|
|
Skin and subcutaneous tissue disorders
Facial burning
|
100.0%
1/1 • 60 days
|
0.00%
0/1 • 60 days
|
|
Immune system disorders
Throat itching
|
100.0%
1/1 • 60 days
|
0.00%
0/1 • 60 days
|
|
Immune system disorders
Throat tightening
|
100.0%
1/1 • 60 days
|
0.00%
0/1 • 60 days
|
|
Skin and subcutaneous tissue disorders
Hives
|
100.0%
1/1 • 60 days
|
0.00%
0/1 • 60 days
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • 60 days
|
0.00%
0/1 • 60 days
|
|
Immune system disorders
Increased tiredness
|
100.0%
1/1 • 60 days
|
0.00%
0/1 • 60 days
|
|
Cardiac disorders
Frequent palpitations
|
100.0%
1/1 • 60 days
|
0.00%
0/1 • 60 days
|
Additional Information
VP, clinical and scientific affairs
QuantumBiopharma
Phone: (416) 814-6057 ex 112
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI can only discuss, present or publish trial results after obtaining consent from the Sponsor (FSD Pharma).
- Publication restrictions are in place
Restriction type: OTHER