Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000665437
Ethics application status
Approved
Date submitted
10/06/2025
Date registered
24/06/2025
Date last updated
24/06/2025
Date data sharing statement initially provided
24/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Efficacy of FSD202 for the treatment of chronic pain associated with idiopathic MCAS (MCAD)
Scientific title
A Phase 2b Randomized, Double-Blind Placebo Controlled Decentralized Trial to Assess the Safety and Efficacy of FSD202 in Participants with Chronic Widespread Musculoskeletal Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome (Disorder) (MCAS/MCAD)
Secondary ID [1] 314624 0
FSD202-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Widespread Musculoskeletal Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome (Disorder) 337765 0
Condition category
Condition code
Inflammatory and Immune System 334096 334096 0 0
Other inflammatory or immune system disorders
Anaesthesiology 334188 334188 0 0
Pain management
Musculoskeletal 334189 334189 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of FSD202 in adult participants with musculoskeletal nociplastic pain associated with MCAS. The study will be conducted as a decentralized clinical trial (DCT).
The study design consists of up to 17 days screening period, up to 4 days for randomization and initial delivery of Investigational Product to participant’s home, a 56-day treatment period, and a 7-day follow-up period. Each participant will participate in the trial for up to 84 days.
Screening will be conducted via a combination of telehealth consultation, nurse/doctor home visit for physical examination and laboratory sample collection, and daily data collection via the App.
The participant’s eligibility for randomization will subsequently be determined at Visit 2 according to the inclusion and exclusion criteria. Participants who meet the eligibility criteria will be randomized remotely. The treatment group will receive 300 mg FSD202 orally twice daily for 56 days .
Participants will complete study App entries daily (about 5-10 mins) throughout the 56 day treatment period .
A nurse/ doctor home visit (60-90 mins each) will be conducted at Day 14 (Visit 5), Day 28 (Visit 7) and Day 56 (Visit 11), during which focused physical examination, pathology sample collection, and Investigational Product compliance checks will be performed.
Telehealth consultations (40-60 minutes each) will be conducted with participants by study site staff at Day 7 (Visit 4), Day 21 (Visit 6), Day 35 (Visit 8), Day 42 (Visit 9), Day 49 (Visit 10) and Day 63 (Visit 12).
A final follow-up telehealth consult will be conducted seven (7) days after the last intake of the investigational product.
Participants will be advised to report any new or worsening symptoms, occurring from the time of randomization until the last follow-up visit, as adverse events (AEs) in the study App, and will receive daily electronic prompts to do so.
Adherence strategies to assess compliance include study drug compliance monitoring via the study app, return of unused Investigational Product during home nurse/ doctor visits for reconciliation.
Intervention code [1] 331249 0
Treatment: Drugs
Comparator / control treatment
Participants are randomized to receive 300 mg FSD202 or a placebo in a ratio of 2:1.
The placebo formulation is visually identical to the FSD202 oral capsule, matching in color (Swedish Orange), shape, size, and shell composition. The placebo capsules will not contain the active pharmaceutical ingredient (ultramicronized N-(2-hydroxyethyl)hexadecanamide, PEA), and will be composed solely of inert lactose powder to ensure indistinguishability from the active treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 341756 0
The treatment effect is defined as a 30% change in the average daily pain intensity score
Timepoint [1] 341756 0
Baseline (calculated as weekly average from Day -7 to Day -1) and Day 56 (calculated as weekly average from Day 50 to Day 56) post intervention commencement
Secondary outcome [1] 448601 0
To evaluate the efficacy of FSD202 as compared to placebo on pain-related function, sleep interference, and global improvement (Composite Outcome)
Timepoint [1] 448601 0
Baseline and Day 56 post intervention commencement
Secondary outcome [2] 448606 0
To evaluate the changes in serum mast cell tryptase, IL-6 and IL-1beta during treatment of FSD202 compared to placebo
Timepoint [2] 448606 0
Baseline and Day 56 post intervention commencement
Secondary outcome [3] 448607 0
To assess safety and tolerability of FSD202 in participants with chronic widespread musculoskeletal nociplastic pain (Composite Outcome)
Timepoint [3] 448607 0
Baseline and Day 56 post intervention commencement

Eligibility
Key inclusion criteria
1. The participant is equal to or more than 18 and equal to or less than 75 years of age at the time of signing the consent form
2. Participant willing to electronically sign ethics committee-approved patient information and informed consent form before undergoing any study-related procedures;
3. Clinical diagnosis of idiopathic MCAS (in the presence or absence of a generalized hypermobility spectrum disorder (G-HSD) or Ehlers-Danlos Syndrome (EDS) as per the global consensus diagnostic criteria (consensus-2 criteria):
a. Medical history shows a constellation of clinical complaints attributable to pathologically increased mast cell (MC) activity (MC mediator release syndrome)
b. Medical history of symptomatic response to inhibitors of MC activation or MC mediator production or action
4. Adults with widespread chronic nociplastic pain (in three or more body regions);
5. Chronic pain of intensity equal to or more than 4.0 but equal to or less than 9.0 on an 11-point Numeric Pain Rating Scale (0-10), with duration of more than 6 months
6. Participant must have a suitable electronic device (smartphone or tablet) and reliable internet connection to enable download and use of the VieDocme and participation in video telehealth consultations
7. The participant is considered reliable and capable of adhering to the protocol (i.e., able to understand and complete online forms and questionnaires, visit schedule, or medication intake according to the judgment of the investigator)
8. Participant agrees to record any rescue medication (eg paracetamol or antihistamines) for chronic widespread musculoskeletal nociplastic pains throughout the trial. Permitted medications can be used according to their documented routine frequency.
9. The participant is willing to maintain current activity and exercise levels throughout the study
10. During the study, the participant 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
11. Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test on Day 1 prior to first dose of study drug
12. Female participants of childbearing potential must use an acceptable method of birth control. Acceptable birth control includes total abstinence from heterosexual intercourse, a vasectomized partner, intrauterine device, or double barrier method including condoms sponge, diaphragm, contraceptives (oral, parenteral, or transdermal), or vaginal ring. Participants considered not of childbearing potential must be surgically sterile (total hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation) or be more than one year post-menopausal, defined as a complete cessation of menstruation for at least one year. Male participants who are sexually active must use an acceptable method of birth control. Acceptable birth control includes total abstinence from heterosexual intercourse, or use of a double barrier method including condoms sponge, diaphragm, contraceptives (oral, parenteral, or transdermal), or vaginal ring used by partner. Periodic abstinence and withdrawal are not acceptable methods of contraception
13. The participant is in good health as judged by the investigator, based on medical history, physical examination, serum chemistry, hematology, and urine analysis
14. At the screening visit, the body mass index (BMI) is between 18.5 and 39.9 kg/m2 inclusive
15. The participant is sufficiently fluent in English language to answer the questionnaires via the App.
Additional Inclusion Criteria (to be confirmed prior to randomization)
16. The participant is compliant with VieDoc data entries during the baseline period, as defined by the completion of a minimum of 5 of 7 daily NPRS scores
17. The average daily pain intensity scores on the NPRS are equal to or more than 4.0 and equal to or less than 9.0 over the last seven days before the Randomization Visit
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The participant 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 (e.g., post-herpetic neuralgia, traumatic injury, prior surgery, complex regional pain syndrome)
2. Adults with chronic cancer pain
3. Adults with inflammatory connective tissue disorder or rheumatological disorder-related pain (e.g., rheumatoid arthritis)
4. Adults with focal musculoskeletal pain
5. Adults with skin diseases (e.g., pemphigus vulgaris, bullous pemphigoid, etc.) that, in the judgment of the investigator, could interfere with reporting of pain due to chronic widespread musculoskeletal nociplastic pains
6. Adults with acute endocrinological disorders (e.g., acute hypothyroidism, acute adrenal insufficiency etc.)
7. Adults with systemic gastrointestinal conditions (e.g., Inflammatory bowel disease)
8. Significant psychological comorbidities: PHQ-9 score more than 20; and GAD-7 score more than 15 (indication of severe anxiety that could interfere with accurate logging of pain ratings)
9. 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)
10. Participant has neurologic disorder unrelated to chronic widespread musculoskeletal nociplastic pains (e.g., phantom limb from amputation, vitamin B12 deficiency, chronic inflammatory demyelinating polyneuropathy), circulatory disorder (e.g., peripheral artery disease), a skin condition in the area of neuropathy that could alter sensation (e.g., plantar ulcer), or other painful conditions (e.g., arthritis) that, in the judgment of the investigator, could interfere with reporting of pain due to chronic widespread musculoskeletal nociplastic pains
11. 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 participant as clinically stable and appropriate for entry into the study. Stable doses of the selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) are allowed for the treatment of depression if the dose is stable for 60 days before Screening Visit
12. Participant has a history of suicide attempt or suicidal behavior 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 or during the treatment period
13. The participant is currently using protocol-specified prohibited medications
14. Positive urine drug screen for illegal or non-prescribed drugs (with the exception of benzodiazepines and cannabinoids) at the Screening Visit or during the treatment period.
15. Pregnant or lactating females or females planning to become pregnant during the study or within 28 days following the last dose of study medication.
16. Male participants planning a partner pregnancy or sperm donation during the study or within three months following the last dose of study medication.
17. Participants 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.
18. Positive human immunodeficiency virus (HIV), hepatitis B or hepatitis C laboratory result.
19. Any clinically significant unstable medical abnormality or acute or chronic disease of the cardiovascular, gastrointestinal, respiratory, hepatic, or renal systems. Participant with aspartate transferase or alanine transferase more than 2.5 times the upper limit of normal (ULN) or alkaline phosphatase more than 3.0 times ULN.
20. Any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests, as determined by the investigator.
21. Known history of seizure disorder, epilepsy, convulsions, or increased intracranial pressure anytime during the participant's life except for pediatric febrile seizures.
22. Participant has received an investigational therapy of any kind within 28 days or 5 half-lives, whichever is longer, before Screening Visit.
23. Participant has had known hypersensitivity or intolerance to the use of Palmitoylethanolamide (PEA), diphenhydramine (e.g. Benadryl) or acetaminophen (e.g. Tylenol) and/or their associated formulation components
24. The participant is a member of the site staff or relative of a staff member
25. Individuals with high baseline serum tryptase levels (defined as above the normal range of 2.2 to 13.2 µg/L) suggestive of Primary or Secondary MCAS

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple central randomisation by computer that is stratified by country to ensure equal number of active and placebo in all countries where trial is happening
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
1/08/2028
Actual
Date of last data collection
Anticipated
29/09/2028
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319184 0
Commercial sector/Industry
Name [1] 319184 0
FSD Pharma Australia Pty Ltd.
Country [1] 319184 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
FSD Pharma Australia Pty Ltd.
Address
Country
Australia
Secondary sponsor category [1] 321653 0
None
Name [1] 321653 0
Address [1] 321653 0
Country [1] 321653 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317768 0
Bellberry Human Research Ethics Committee H
Ethics committee address [1] 317768 0
Ethics committee country [1] 317768 0
Australia
Date submitted for ethics approval [1] 317768 0
08/04/2025
Approval date [1] 317768 0
22/05/2025
Ethics approval number [1] 317768 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142078 0
Dr Arul Sivanesan
Address 142078 0
Vitalis Clinical Research, 456 St Kilda Rd, Melbourne VIC 3004
Country 142078 0
Australia
Phone 142078 0
+61 0422156206
Fax 142078 0
Email 142078 0
[email protected]
Contact person for public queries
Name 142079 0
Darryl Davies
Address 142079 0
iNGENu CRO, Unit 22/456 St Kilda Rd, Melbourne VIC 3004
Country 142079 0
Australia
Phone 142079 0
+61 1300633226
Fax 142079 0
Email 142079 0
[email protected]
Contact person for scientific queries
Name 142080 0
Darryl Davies
Address 142080 0
iNGENu CRO, Unit 22/456 St Kilda Rd, Melbourne VIC 3004
Country 142080 0
Australia
Phone 142080 0
+61 1300633226
Fax 142080 0
Email 142080 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.