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| Name | Class |
|---|---|
| Gencor Pacific Limited, Hong Kong | INDUSTRY |
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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:
The trial will include two participation modes:
This is an interventional, phase II, randomised, double-blind, placebo-controlled, parallel dose safety study in healthy adults to assess long term population exposure to Palmitoylethanolamide (Levagen™).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEA (Levagen) | Experimental | 600mg PEA each day. 1 oral capsule is taken twice per day after food, each capsule contains 300mg. |
|
| Placebo | Placebo Comparator | 600mg microcrystalline cellulose a day. 1 oral capsule is taken twice per day after food, each capsule contains 300mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palmitoylethanolamide (PEA) | Dietary Supplement | Levagen™ capsule containing 300mg Palmitoylethanolamide (PEA). 600mg PEA per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to the end of the study period in participants with SAEs | 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)] | From Day O (Baseline) to 54 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to month 12 in AEs | Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in all adverse events (AEs) | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in medical assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Change from baseline to month 12 in Vital Signs (temperature) | Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by temperature (celcius). | Baseline (Day 0) to month 12. |
| Exploratory: Change from baseline to month 12 in Vital Signs (O2 saturation) |
Inclusion Criteria:
Exclusion Criteria:
Male and Female cisgender
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| RV Venkatesh | Contact | (852) 2987 6894 | venkat@gencorpacific.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical | Recruiting | Brisbane | Queensland | 4006 | Australia |
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| ID | Term |
|---|---|
| C005958 | palmidrol |
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| Placebo | Other | Placebo capsules contain 300 mg microcrystalline cellulose (MCC), 600mg per day. |
|
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.
| Baseline (day 0) and Month 12 |
| Change from baseline to month 12 in Vital Signs (blood pressure) | 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). | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in Vital Signs (heart rate) | 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). | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in clinical laboratory determinations (Full Blood Count) | 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). | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in clinical laboratory determinations (fasting glucose) | Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by fasting glucose. | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in clinical laboratory determinations (insulin) | Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by insulin. | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in clinical laboratory determinations (lipids). | Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by lipids. | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in clinical laboratory determinations (electrolytes) | Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by electrolytes. | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in clinical laboratory determinations (kidney function tests) | 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. | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in clinical laboratory determinations (Liver function tests) | 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. | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in sleep questionnaires. | 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. | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in anxiety questionnaires | 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. | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in Quality of life | 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). | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in Musculoskeletal health questionnaire | 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. | Baseline (Day 0) to month 12. |
| Change from baseline to month 12 in Gastrointestinal tolerance questionnaire | Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Gastrointestinal tolerance questionnaire | Baseline (Day 0) to month 12. |
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by O2 saturation (%). |
| Baseline (Day 0) to month 12. |
| Exploratory: Change from baseline to month 12 in PEA | Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in PEA plasma concentration over time | Baseline (Day 0) to month 12. |
| Exploratory: Change from baseline to month 12 in serum BDNF, CRP, and cytokines | 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)] | Baseline (Day 0) to month 12. |