Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

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.

Full Title of Study: “Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain: a Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2015

Detailed Description

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.

Interventions

  • Dietary Supplement: Ultramicronized PEA (Normast)
    • 600 mg

Arms, Groups and Cohorts

  • Experimental: Ultramicronized PEA (Normast)
    • Normast is ultramicronized Palmitoylethanolamide (PEA) classified as “Dietary foods for special medical purposes”.
  • Placebo Comparator: Microgranules
    • Same as Normast, without active component.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • Insomnia Severity Index
    • Time Frame: 12 weeks
  • anxiety(GAD-10)
    • Time Frame: 12 weeks
  • depression(MDI)
    • Time Frame: 12 weeks
  • NNT for 33% and 50% pain reduction
    • Time Frame: 12 weeks
  • Combined spasticity and pain score (CPSS)
    • Time Frame: 12 weeks
  • Numbers of responders (33% pain reduction) in those with and without allodynia/hyperalgesia and those with different pain symptoms (NPSI)
    • Time Frame: 12 weeks

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Danish Pain Research Center
  • Collaborator
    • Spinal Cord Injury Centre of Western Denmark
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sven R. Andresen, MD, Principal Investigator, Spinal Cord Injury Centre of Western Denmark

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