Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

Danish Pain Research Center73 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Neuropathic Pain Spinal Cord Injury

Interventions

Ultramicronized PEA (Normast)DIETARY_SUPPLEMENT

600 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Department of Spinal Cord Injuries

Hornbæk, Denmark

Spinal Cord Injury Centre of Western Denmark

Viborg, Denmark

Outcomes

Primary Outcomes

Change in mean pain intensity on a 0-10 numerical rating scale from baseline week to last week of treatment

Time frame: 12 weeks

Secondary Outcomes

Spasticity/spasms and sleep disturbance, change in mean score from baseline to last week of treatment

Time frame: 12 weeks

Modified Tardieu and clonus over ankle joints

Time frame: 12 weeks

Spasticity and spasms on a 0-10 NRS

Time frame: 12 weeks

Health related quality of life S-TOPS

Time frame: 12 weeks

Global Impression of Change

Time frame: 12 weeks

Pain relief of overall pain and at-and below level pain

Time frame: 12 weeks

allodynia(touch and cold)

Time frame: 12 weeks

Pain symptoms evaluated by NPSI

Time frame: 12 weeks

pain impact on activities, sleep and mood

Time frame: 12 weeks

effect on unpleasantness

Time frame: 12 weeks

escape medication

Time frame: 12 weeks

Data from ClinicalTrials.gov

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