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

NCT05652907 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: FSD201-010
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  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

  Day 28

Study Arms (2)

FSD201

EXPERIMENTAL

Participants will receive 600 milligrams (mg) FSD201 tablet twice daily (BID) orally from Day 0 to Day 56.

Drug: FSD201

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to 600 mg FSD201 tablets twice daily (BID) orally from Day 0 to Day 56.

Drug: Placebo

Interventions

FSD201 DRUG

Tablets for oral administration.

FSD201

Placebo DRUG

Placebo tablets matched to FSD201 for oral administration.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of idiopathic MCAS as per the global consensus diagnostic criteria
• Adults with widespread chronic pain (in three or more body regions);
• Chronic pains of intensity greater than or equal to 4.0 but less than or equal to 9.0 on a Numeric Pain Rating Scale, symptom duration of more than 6 months;
• Subject agrees to use only acetaminophen (up to 1000 mg per dose and not to exceed 3000 mg/day) or diphenhydramine (up to 300 mg/day) as rescue medication for chronic widespread musculoskeletal nociplastic pains throughout the trial;
• The subject is willing to maintain current activity and exercise levels throughout the study;
• During the study, the subject agrees not to initiate or change any non-pharmacologic interventions (including chiropractic care, physical therapy, psychotherapy, and massage therapy). Any ongoing non-pharmacologic intervention must be stable for at least 4 weeks before screening and should be continued for the duration of the study;

You may not qualify if:

• The subject has pain that cannot be clearly differentiated from or that could interfere with the assessment of chronic musculoskeletal nociplastic pain secondary likely to idiopathic MCAS (post-herpetic neuralgia, traumatic injury, prior surgery, complex regional pain syndrome);
• Adults with chronic cancer pain;
• Adults with inflammatory connective tissue disorder or rheumatological disorder-related pain, for example rheumatoid arthritis;
• Adults with focal musculoskeletal pain;
• Adults with skin diseases (chronic urticaria, pemphigus, lupus, rosacea etc.);
• Adults with endocrinological disorders (acute hypothyroidism, acute adrenal insufficiency etc.);
• Adults with systemic gastrointestinal conditions (Inflammatory bowel disorders);
• Significant psychological comorbidities: PHQ-9 score greater than 20; and GAD-7 score greater than 15 (indication of severe anxiety that could interfere with accurate logging of pain ratings);
• Current or recent (within 12 months of screening) history of a substance use disorder including cannabinoid or alcohol use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5);
• Subject has neurologic disorder unrelated to chronic widespread musculoskeletal nociplastic pains (phantom limb from amputation, vitamin B12 deficiency, chronic inflammatory demyelinating polyneuropathy), circulatory disorder (peripheral artery disease), a skin condition in the area of neuropathy that could alter sensation (plantar ulcer), or other painful conditions (arthritis) that could interfere with reporting of pain due to chronic widespread musculoskeletal nociplastic pains;
• Current severe or uncontrolled major depressive disorder or anxiety disorders. Mild to moderate major depression or anxiety disorders are permitted provided that the investigator assesses the patient as clinically stable and appropriate for entry into the study. Stable doses of SSRIs are allowed for the treatment of depression if the dose is stable for 60 days before Screening Visit;
• Subject has a history of suicide attempt or suicidal behaviour within the last 12 months or has suicidal ideation within the previous 12 months or who is at significant risk to commit suicide, as judged by the Investigator at Screening and/or Randomization Visit;
• Patients with active malignancy or history of malignancy, except for basal cell or squamous cell carcinoma and actinic keratosis. Basal cell carcinoma and small squamous cell carcinoma of the skin which have been excised according to guidelines within the last 5 years or in situ cervical carcinoma that has been fully treated and shows no evidence of recurrence are allowed;
• Individuals with generalized joint hypermobility secondary to hereditary connective tissue disorders like Ehlers Danlos Syndrome;
• Individuals with high baseline serum tryptase levels suggestive of Primary or Secondary MCAS (defined as above the normal range of 2.2 to 13.2 µg/L).

Sponsors & Collaborators

• Quantum Biopharma: lead

Study Sites (3)

Saint Charles Clinical Research

Weldon Spring, Missouri, 63304, United States

Location

Norman Marcus Pain Institute

New York, New York, 10016, United States

Location

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Mast Cell Activation Syndrome

Condition Hierarchy (Ancestors)

Mast Cell Activation Disorders; Immune System Diseases

Limitations and Caveats

The effect of the intervention cannot be determined because the trial was terminated prior to full enrollment.

Results Point of Contact

• Title: VP, clinical and scientific affairs
• Organization: QuantumBiopharma

andrzej@quantumbiopharma.com

(416) 814-6057 ex 112

Study Officials

• Andrzej Chruscinski, MD

  FSD Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 15, 2022
• Study Start: January 19, 2023
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: April 21, 2026
• Results First Posted: April 21, 2026

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (2)