NCT05652907Phase 2Terminated

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-05-24Actual

Enrollment · participants2Actual

Source updated2026-04-21Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-04-21 · 1 field changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: Targeted ~~treatment~~ ~~effect~~ of 30% ~~decrease~~ ~~from~~ ~~baseline~~ to Day 28 in the ~~average~~ ~~daily~~ ~~pain~~ ~~intensity~~

+ After

Measure: Targeted Treatment Effect of 30% Decrease From Baseline to Day 28 in the Average Daily Pain Intensity

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Study details

Conditions studied

Mast Cell Activation Syndrome; Mast Cell Activation Disorder Idiopathic

Treatments or interventions studied

FSD201Drug
PlaceboDrug

Primary outcomes · main study measures

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measure: Targeted Treatment Effect of 30% Decrease From Baseline to Day 28 in the Average Daily Pain Intensity; description: 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; timeFrame: Day 28

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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