Palmitoylethanolamide (PEA) trials recruiting now

11 registrations that name palmitoylethanolamide as a study arm and are recruiting or about to, as ClinicalTrials.gov listed them on Oct 20, 2026. Read each listing for its full criteria and current status.

Kymata never assesses eligibility. Each listing names its own criteria; only its study team can say whether someone can join. Trial doses are given under the trial's monitoring and are not a schedule for anyone outside it.

Filter 11 registrations

Status

Phase

All 11 registrations

RecruitingNCT07315516

Sleep and Stress Study

  • Phase 2
  • RDC Clinical Pty Ltd
  • About 240 people
  • Started Apr 7, 2026

In plain words A Phase 2 study of palmitoylethanolamide in people 18 and older, run by RDC Clinical Pty Ltd. It plans to enroll about 240 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 and older. Conditions: Sleep Disorder (Disorder); Stress; Anxiety.

  • Generally healthy adults aged 18 and over.
  • Able to provide informed consent.
  • Score of at least 14 on the Perceived Stress Scale (PSS).
  • Those with a sleep complaint with a frequency of at least 2 times per week(1)

4 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Lavender Oil; Palmitoylethanolamide (PEA); Oleoylethanolamide; Placebo

Registered summary

The goal of this clinical trial is to learn if natural supplements (lavender oil, PEA, and OEA) work to improve sleep and reduce stress in adults with moderate stress levels and sleep difficulties. It will also learn about the safety of these natural supplements. The full summary is on the listing.

Where, as registered

No US site; Australia (1).

RecruitingNCT07772141

Palmitoylethanolamide Modulates Central Sensitisation and Neuroinflammation in Chronic Low Back Pain

  • No phase
  • Beni-Suef University
  • About 106 people
  • Started Jan 1, 2026

In plain words A study of palmitoylethanolamide in people 18 to 65, run by Beni-Suef University. It plans to enroll about 106 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 65. Conditions: Chronic Low-back Pain.

  • With chronic pain (more than 3 months)
  • Patients with NRS (4 -7)
  • MRI evidence of disc protrusion or prolapse limited to one or two lumbar discs, without extensive multi-level pathology
  • Diagnosed clinically with low back pain due to disc disease.

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Palmitoylethanolamide

Registered summary

Low back pain (LBP) is a public and occupational health problem that is a major professional, economic and social burden. Up to 84% of the general population will experience an episode of LBP during its life time, and recurrence rates are high. Acute LBP is the second reason for consultations in general medicine, and chronic LBP is the eighth. One in five LBP episodes result in sick leave. LBP represents 30% of sick leaves that are longer than 6 months, and 20% of work accidents. The full summary is on the listing.

Where, as registered

No US site; Egypt (1).

RecruitingNCT07028528

Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy

  • Phase 2
  • RDC Clinical Pty Ltd
  • About 80 people
  • Started Jul 1, 2025

In plain words A Phase 2 study of palmitoylethanolamide in people 18 to 75, run by RDC Clinical Pty Ltd. It plans to enroll about 80 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 75. Conditions: Diabetic Peripheral Neuropathy.

  • Adults aged 18-75 years.
  • Using prescribed glucose-lowering medications, including oral medications (stable dose for 3 months or more) and/or insulin for diabetes (type 1 or 2).
  • Scoring12 or more on the Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS).
  • Able to provide informed consent.

3 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Levagen+; Placebo

Registered summary

The goal of this clinical trial is to assess the efficacy of Levagen+ supplementation for the symptoms of diabetic peripheral neuropathy (DPN) in patients with DPN. Participants will have remote visits and attend a local pathology centre for blood draws. They will take the study product for 12 weeks, from baseline to week 12 they will have remote visits every 3 weeks.

Where, as registered

No US site; Australia (1).

RecruitingNCT07609810

Palmitoylethanolamide in Ulcerative Colitis

  • No phase
  • Ain Shams University
  • About 60 people
  • Starts Aug 15, 2026 (estimated)

In plain words A study of palmitoylethanolamide in people 18 to 65, run by Ain Shams University. It plans to enroll about 60 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 65. Conditions: Ulcerative Colitis (UC).

  • Confirmed diagnosis of ulcerative colitis (UC) by established clinical and endoscopic criteria.
  • Active mild-to-moderate UC patients defined by a SCCAI score ≥ 5 and < 12 at screening not responding to 5-aminosalicylates (5-ASA) defined as persistent rectal bleeding beyond 2 weeks or failure to achieve sustained symptom relief after…

The exclusion criteria are on the listing.

What it tests, as registered

Palmitoylethanolamide (PEA); Placebo

Registered summary

Evaluate the effects of PEA supplementation on disease activity, health-related quality of life (HRQoL) and inflammatory biomarkers in patients with active mild-to-moderate UC.

Where, as registered

No US site; Egypt (1).

RecruitingNCT07689214

Normast3 for Adults With Diabetic Polyneuropathy

  • No phase
  • University of Roma La Sapienza
  • About 40 people
  • Started Jul 17, 2024

In plain words A study of palmitoylethanolamide in people 18 to 80, run by University of Roma La Sapienza. It plans to enroll about 40 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 80. Conditions: Diabete Type 2.

What it tests, as registered

Normast® 3 - a food for special medical purposes (FSMP) containing co-micronized palmitoylethanolamide (PEA) with rutin and hydroxytyrosol. It is designed to support the management of diabetic polyneu; Placebo

Registered summary

The goal of this clinical trial is to find out if a new supplement called Normast® 3 can help reduce nerve pain and improve nerve function in adults with diabetic polyneuropathy (DPN). DPN is a common complication of diabetes that damages nerves, often causing burning, tingling, or stabbing pain, as well as problems with the autonomic nervous system, which controls things like sweating and heart rate. The full summary is on the listing.

Where, as registered

No US site; Italy (1).

RecruitingNCT06187090

The Supplementation Therapy in Autism and Response to Treatment Study

  • No phase
  • University of Udine
  • About 20 people
  • Started Sep 1, 2023

In plain words A study of palmitoylethanolamide in people 18 to 35, run by University of Udine. It plans to enroll about 20 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 35. Conditions: Autism; Autism Spectrum Disorder; Autism Spectrum Disorder High-Functioning; Asperger Syndrome; Depressive Symptoms; Anxiety State.

  • Individuals diagnosed with Level 1 ASD, as defined using Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5);
  • Aged 18-35 years;
  • To be able to understand and communicate in Italian;
  • To be able to give informed consent.

The exclusion criteria are on the listing.

What it tests, as registered

Oral Ultramicronized-Palmitoylethanolamide (um-PEA; 600 mg per day) in tablet form

Registered summary

In addition to the "core" symptoms of ASD (i.e., impaired communication, impaired reciprocal social interaction and restricted, repetitive and stereotyped patterns of behaviors or interests), it is estimated that up to 70% of autistic people present at least one comorbid psychiatric disorder, leading to a deterioration in quality of life, a greater demand for support and worse prognosis and outcome. Anxiety and depressive symptoms would seem to be more present in individuals with Level 1 ASD, requiring their prioritisation against core symptoms. The full summary is on the listing.

Where, as registered

No US site; Italy (1).

RecruitingNCT07359534

Training Health Recovery and Improvement Via Levagen+® Evaluation

  • No phase
  • University of Westminster
  • About 20 people
  • Started Mar 10, 2025

In plain words A study of palmitoylethanolamide in people 18 to 50, run by University of Westminster. It plans to enroll about 20 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 50; healthy volunteers accepted. Conditions: Exercise Recovery.

  • Healthy subjects
  • Males and females (18-50 years of age)
  • Trained cyclists/triathletes indicated by:
  • Minimum functional threshold power (FTP, an indication of the highest average power output a cyclist can maintain for 60 minutes) of 2.9W/kg for males and 2.5W/kg for females

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Levagen+® Palmitoylethanolamide (PEA); Placebo

Registered summary

INTRODUCTION: Sports supplements and ergogenic aids are widely used for performance enhancement in recreational and professional sports. Athletes undergo intense training to improve their cardiorespiratory and muscular systems, aiming for positive adaptations. However, intensified training without appropriate dietary support can pose risks such as inadequate muscle recovery, weakened immune function, and reduced sleep quality, leading to increased susceptibility to illness and heightened physiological and psychological stress. The full summary is on the listing.

Where, as registered

No US site; United Kingdom (1).

Not yet recruitingNCT07316660

Palmitoylethanolamide vs Ibuprofen for Pain After ESWL

  • No phase
  • Benha University
  • About 120 people
  • Starts Jan 1, 2026 (estimated)

In plain words A study of palmitoylethanolamide in people 18 to 65, run by Benha University. It plans to enroll about 120 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 65. Conditions: Pain After Extracorporeal Shock Wave Lithotripsy; Palmitoylethanolamide.

  • Age 18-65 years
  • ASA I or II
  • Undergoing elective ESWL for renal or upper ureteric calculi
  • Expected discharge same day or within 24 hours (outpatient ESWL).

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Palmitoylethanolamide (PEA); Ibuprofen (Brufen®)

Registered summary

Pain after extracorporeal shock wave lithotripsy (ESWL), a non-surgical procedure used to treat kidney stones, is common and is usually treated with non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. However, NSAIDs may cause side effects in some patients, including stomach irritation and kidney problems. Palmitoylethanolamide (PEA) is a naturally occurring substance in the body with anti-inflammatory and pain-relieving properties and has been shown to be safe in previous studies. The full summary is on the listing.

Where, as registered

No US site; Egypt (1).

Not yet recruitingNCT07681063

Palmitoylethanolamide/Luteolin Supplementation in Older Adults Undergoing Cardiac Surgery

  • No phase
  • Fondazione IRCCS San Gerardo dei Tintori
  • About 100 people
  • Starts Jun 2026 (estimated)

In plain words A study of palmitoylethanolamide in people 65 and older, run by Fondazione IRCCS San Gerardo dei Tintori. It plans to enroll about 100 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 65 and older. Conditions: Postoperative Cognitive Dysfunction.

  • Age ≥ 65 years
  • Both genders
  • Undergoing elective aortic or mitral valve replacement/reconstruction with or without coronary artery bypass grafting (CABG), at the Cardiac Surgery Unit of IRCCS San Gerardo dei Tintori Foundation (Monza, Italy)
  • Prognosis quoad vitam ≥ 3 months

3 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml); Standard of Care

Registered summary

Postoperative Cognitive Dysfunction (POCD) is a common complication after surgery, particularly among older adults. It is characterized by cognitive impairment, reduced functional independence, and decreased quality of life. Growing evidence suggests that neuroinflammation plays a relevant role in POCD development and persistence. Palmitoylethanolamide (PEA) is an endogenous lipid mediator involved in the regulation of neuroinflammatory processes through the modulation of non-neuronal cells, while luteolin is a flavonoid with well-known antioxidant properties. The full summary is on the listing.

Where, as registered

No US site; Italy (1).

Not yet recruitingNCT07680101

Intra-Articular Adelmidrol 2%/Hyaluronic Acid 1% With or Without m/umPEA, in Knee Pain Due to Joint Degeneration.

  • No phase
  • Universita di Verona
  • About 80 people
  • Starts Jun 2026 (estimated)

In plain words A study of palmitoylethanolamide in people 40 and older, run by Universita di Verona. It plans to enroll about 80 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 40 and older. Conditions: Degenerative Joint Disease of Knee; Rheumatoid Arthritis.

  • Age ≥ 40 years
  • Male or female
  • Diagnosis of unilateral or bilateral knee joint degeneration due to osteoarthritis or rheumatoid arthritis, Kellgren-Lawrence grade II-III
  • Duration of knee pain ≥ 6 months

4 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Adelmidrol 2% / Hyaluronic Acid 1%; micronized Palmitoylethanolamide (mPEA) 300mg + ultramicronized Palmitoylethanolamide (umPEA) 600mg

Registered summary

Degenerative knee joint diseases are characterized by chronic pain, inflammation, and functional impairment. In these conditions, mast cell density in the synovial membrane is increased, resulting in an excessive release of biological mediators involved in key mechanisms of neuroinflammation and in hyaluronic acid depolymerisation. Adelmidrol acts as a preventive antioxidant due to its radical scavenging activity, thus protecting hyaluronic acid from oxidative degradation and reducing mast cell degranulation. The full summary is on the listing.

Where, as registered

No US site; Italy (1).

Not yet recruitingNCT06777680

Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke

  • No phase
  • Ospedali Riuniti Trieste
  • About 60 people
  • Starts Jan 2025 (estimated)

In plain words A study of palmitoylethanolamide in people 60 and older, run by Ospedali Riuniti Trieste. It plans to enroll about 60 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 60 and older. Conditions: Acute Ischemic Stroke AIS.

  • age ≥ 60 years
  • both genders
  • first acute ischemic stroke in the middle cerebral artery area confirmed by angio-CT and CTP, eligible for mechanical thrombectomy according to national guidelines
  • NIHSS > 6

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg); Placebo; Thrombectomy

Registered summary

Acute ischemic stroke is caused by reduced blood supply to the brain associated with neuroinflammation. This mechanism contributes to acute neuronal death and persists even after reopening of the closed vessel, with consequent limitation of clinical and functional improvement. Experimental and clinical evidence demonstrated the anti-inflammatory and neuroprotective effect of micronized and ultramicronized Palmitoylethanolamide (PEA). The full summary is on the listing.

Where, as registered

No US site; Italy (1).

ClinicalTrials.gov lists 19 open registrations for this search, including ones where palmitoylethanolamide is not a study arm or that are past the 11 we keep. Search them on ClinicalTrials.gov (opens in new tab).

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