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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06717867
Registration number
NCT06717867
Ethics application status
Date submitted
21/11/2024
Date registered
5/12/2024
Date last updated
25/03/2025
Titles & IDs
Public title
Long-Term PEA Safety Study
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Scientific title
A Randomised, Double-blind Placebo-controlled Study in Healthy Adults to Assess Long Term Population Exposure to Palmitoylethanolamide (Levagen™) to Assess Clinical Safety.
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Secondary ID [1]
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Safety
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Palmitoylethanolamide (PEA)
Other interventions - Placebo
Experimental: PEA (Levagen) - 600mg PEA each day. 1 oral capsule is taken twice per day after food, each capsule contains 300mg.
Placebo comparator: Placebo - 600mg microcrystalline cellulose a day. 1 oral capsule is taken twice per day after food, each capsule contains 300mg.
Treatment: Other: Palmitoylethanolamide (PEA)
Levagen™ capsule containing 300mg Palmitoylethanolamide (PEA). 600mg PEA per day.
Other interventions: Placebo
Placebo capsules contain 300 mg microcrystalline cellulose (MCC), 600mg per day.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline to the end of the study period in participants with SAEs
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Assessment method [1]
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Change from baseline to the end of the study period in: Number of participants with Serious Adverse Events (SAE) after first administration of study drug through to the last dose of study drug plus 2 weeks \[time frame: after first administration of study drug through to the last dose of study drug (12 months) plus 2 weeks (week 54)\]
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Timepoint [1]
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From Day O (Baseline) to 54 weeks
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Secondary outcome [1]
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Change from baseline to month 12 in AEs
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Assessment method [1]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in all adverse events (AEs)
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Timepoint [1]
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Baseline (Day 0) to month 12.
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Secondary outcome [2]
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Change from baseline to month 12 in medical assessment
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Assessment method [2]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by Medical assessment (by a doctor). The Medical Assessment is a medical review to elucidate symptoms of any occult medical conditions will be conducted for all participants and a medical assessment will then be performed. The assessment will include a review of vital signs and measurements, general appearance, brief cranial nerve assessment, cardiovascular, gastrointestinal and respiratory assessments. Other body systems will be examined (e.g. neurological, renal, musculoskeletal, ear, nose and throat or skin) as is deemed necessary by the trial doctor as guided by the medical review.
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Timepoint [2]
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Baseline (day 0) and Month 12
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Secondary outcome [3]
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Change from baseline to month 12 in Vital Signs (temperature)
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Assessment method [3]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by temperature (celsius).
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Timepoint [3]
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Baseline (Day 0) to month 12.
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Secondary outcome [4]
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Change from baseline to month 12 in Vital Signs (blood pressure)
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Assessment method [4]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by blood pressure (mmHg).
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Timepoint [4]
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Baseline (Day 0) to month 12.
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Secondary outcome [5]
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Change from baseline to month 12 in Vital Signs (heart rate)
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Assessment method [5]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by heart rate (bpm).
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Timepoint [5]
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Baseline (Day 0) to month 12.
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Secondary outcome [6]
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Change from baseline to month 12 in Vital Signs (oxygen saturation)
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Assessment method [6]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by oxygen saturation (%).
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Timepoint [6]
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Baseline (Day 0) to month 12.
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Secondary outcome [7]
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Change from baseline to month 12 in clinical laboratory determinations (Full Blood Count)
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Assessment method [7]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by Full Blood Count (FBC).
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Timepoint [7]
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Baseline (Day 0) to month 12.
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Secondary outcome [8]
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Change from baseline to month 12 in clinical laboratory determinations (fasting glucose)
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Assessment method [8]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by fasting glucose.
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Timepoint [8]
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Baseline (Day 0) to month 12.
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Secondary outcome [9]
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Change from baseline to month 12 in clinical laboratory determinations (insulin)
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Assessment method [9]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by insulin.
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Timepoint [9]
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Baseline (Day 0) to month 12.
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Secondary outcome [10]
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Change from baseline to month 12 in clinical laboratory determinations (lipids).
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Assessment method [10]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by lipids.
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Timepoint [10]
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Baseline (Day 0) to month 12.
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Secondary outcome [11]
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Change from baseline to month 12 in clinical laboratory determinations (electrolytes)
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Assessment method [11]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by electrolytes.
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Timepoint [11]
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Baseline (Day 0) to month 12.
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Secondary outcome [12]
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Change from baseline to month 12 in clinical laboratory determinations (kidney function tests)
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Assessment method [12]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by kidney function tests.
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Timepoint [12]
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Baseline (Day 0) to month 12.
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Secondary outcome [13]
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Change from baseline to month 12 in clinical laboratory determinations (Liver function tests)
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Assessment method [13]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by liver function tests.
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Timepoint [13]
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Baseline (Day 0) to month 12.
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Secondary outcome [14]
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Change from baseline to month 12 in PEA
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Assessment method [14]
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Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in PEA plasma concentration over time
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Timepoint [14]
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Baseline (Day 0) to month 12.
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Secondary outcome [15]
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Change from baseline to month 12 in serum BDNF, CRP, and cytokines
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Assessment method [15]
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Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Serum BDNF, CRP, and cytokines (e.g., IL-1b, IL-6, IL-10, TNF-a)\]
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Timepoint [15]
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Baseline (Day 0) to month 12.
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Secondary outcome [16]
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Change from baseline to month 12 in sleep questionnaires.
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Assessment method [16]
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Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Leeds sleep evaluation questionnaire (LSEQ). Each domain of the LSEQ is scored using a visual analogue scale (VAS) where participants mark their response on a line ranging from 0 to 100. Higher scores indicate better sleep quality or easier sleep-related behaviors in the respective domain. Lower scores indicate poorer sleep quality or more difficulty in the respective domain.
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Timepoint [16]
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Baseline (Day 0) to month 12.
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Secondary outcome [17]
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Change from baseline to month 12 in anxiety questionnaires
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Assessment method [17]
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Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Anxiety questionnaires (Beck Anxiety Inventory Scale). Scores from 0 to 63, a score of 0-21 indicates low anxiety whereas a score of 36 and above indicates potentially concerning levels of anxiety.
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Timepoint [17]
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Baseline (Day 0) to month 12.
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Secondary outcome [18]
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Change from baseline to month 12 in Quality of life
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Assessment method [18]
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Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Quality of life (RAND 36-Item Short Form Survey Instrument, Rand SF-36).
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Timepoint [18]
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Baseline (Day 0) to month 12.
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Secondary outcome [19]
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Change from baseline to month 12 in Musculoskeletal health questionnaire
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Assessment method [19]
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Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Musculoskeletal health questionnaire (MSK-HQ). MSK-HQ is scored on a range of 0-56, with a better score indicating better MSK-HQ health status.
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Timepoint [19]
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Baseline (Day 0) to month 12.
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Secondary outcome [20]
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Change from baseline to month 12 in Gastrointestinal tolerance questionnaire
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Assessment method [20]
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Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Gastrointestinal tolerance questionnaire
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Timepoint [20]
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Baseline (Day 0) to month 12.
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Eligibility
Key inclusion criteria
* Adults (18 years and older)
* Generally healthy
* Able to provide informed consent
* BMI 18.5 - 35.0 kg/m2
* Agree to not participate in another clinical trial during enrolment period
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Serious illness e.g., mood disorders (such as depression or bipolar disorder), anxiety, neurological disorders (such as MS), kidney disease, liver disease or heart conditions
* Unstable illness (e.g., diabetes and thyroid gland dysfunction)
* History of renal function impairment
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy [(excluding low dose aspirin (under 300 mg/day)]
* Regular consumption (>4 times a week) of PEA over the past 2 weeks
* Substance Abuse (illicit and/or prescription) Drug (prescription or illegal substances) abuse
* Chronic past (within 12-months) and/or current alcohol use (>14 alcoholic drinks week)
* Pregnant or lactating women
* Allergic, sensitive, or intolerant to any of the ingredients in active or placebo formula
* Has a clinically significant abnormal finding on the medical assessment, medical history, vital signs or clinical laboratory results at screening.
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/01/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2027
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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RDC Clinical - Brisbane
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Recruitment postcode(s) [1]
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4006 - Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
RDC Clinical Pty Ltd
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Gencor Pacific Limited
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this clinical trial is to learn about the long term safety of PEA supplementation in healthy adults. This clinical trial will be in both males and females who are 18 years or older and are healthy volunteers. The main aim of the study is to assess the safety of long-term use of PEA by assessing the difference between the two groups for serious adverse events, non-serious adverse events, vital signs and biochemistry following 12 months of PEA supplementation. Participants will: * Have their suitability for the study checked against the full inclusion/exclusion criteria during the screening process. * Eligible participants will then attend a baseline visit where assessments will be performed and the participant will be randomly assigned to receive the study product or a placebo. Participants will then consume their assigned study product every day for 12 months. Participants will not know what product they have been assigned during the study. * Following the baseline visit, there will be 4 in clinic visits over 12 months. On months where participants do not attend the clinic there will be a check in phone call. * During clinic visits there will be safety assessments performed, blood sampling and questionnaires.
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Trial website
https://clinicaltrials.gov/study/NCT06717867
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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RV Venkatesh
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Address
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Country
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Phone
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(852) 2987 6894
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06717867
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