Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Randomized, double-blinded, placebo-controlled, parallel group study of ultramicronized PEA (Normast)600 mg x 2 daily or corresponding placebo with a week of baseline period followed by 1 x 12 weeks treatment period.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..

NCT01200524

Nerve Pain

COMPLETED PHASE2

Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain

NCT04431778

Peripheral Neuropathic Pain

UNKNOWN PHASE2

Milnacipran for Lumbosacral Radicular Pain

NCT01777581

Radicular Pain Related to Lumbosacral Disc Disease

COMPLETED PHASE4

Dose-Tolerability Titration Study to Evaluate The Efficacy And Safety Of Perampanel (E2007) In Patients With Post-Herpetic Neuralgia (PHN)

NCT00592774

Neuralgia

COMPLETED PHASE2

Mechanisms of Stimulation for Pain Alleviation

NCT06741579

Chronic Neuropathic Pain in the Low Back and Legs Peripheral Nerve Stimulation Chronic Neuropathic Pain

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study design: Randomized, double-blinded, placebo-controlled, parallel, multi-center study of ultramicronized PEA (Normast)with a week of baseline period followed by 1 x 12 weeks treatment period.

Methodology: Given Normast 600mg x 2 daily or corresponding placebo and kept on that dose for 12 weeks.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuropathic Pain Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ultramicronized PEA (Normast)

Normast is ultramicronized Palmitoylethanolamide (PEA) classified as "Dietary foods for special medical purposes".

Group Type EXPERIMENTAL

Ultramicronized PEA (Normast)

Intervention Type DIETARY_SUPPLEMENT

600 mg

Microgranules

Same as Normast, without active component.

Group Type PLACEBO_COMPARATOR

Ultramicronized PEA (Normast)

Intervention Type DIETARY_SUPPLEMENT

600 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultramicronized PEA (Normast)

600 mg

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged 18 years or more with at- and/or below-level neuropathic pain for at least 3 months due to trauma or disease of the spinal cord or cauda equina (of at least 6 months old) with a mean pain intensity from 4 to 9 on a 0-10 point numeric rating scale (NRS) during a one-week baseline period will be eligible for the study

Exclusion Criteria

* known concomitant severe cerebral damage, terminal illness, planned surgery, pregnancy or lactation, alcohol or substance abuse, hypersensitivity to PEA or carrier, and psychiatric disease except depression.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No