Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

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

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 Overview

• Status: Completed
• Conditions: Neuropathic Pain; Spinal Cord Injury
• Intervention / Treatment: Dietary supplement: Ultramicronized PEA (Normast)

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hornbaek, Denmark, 3100
    • Department of Spinal Cord Injuries
  • Viborg, Denmark, 8800
    • Spinal Cord Injury Centre of Western Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultramicronized PEA (Normast); Normast is ultramicronized Palmitoylethanolamide (PEA) classified as "Dietary foods for special medical purposes".	Dietary supplement: Ultramicronized PEA (Normast); 600 mg
Placebo Comparator: Microgranules; Same as Normast, without active component.	Dietary supplement: Ultramicronized PEA (Normast); 600 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in mean pain intensity on a 0-10 numerical rating scale from baseline week to last week of treatment	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Spasticity/spasms and sleep disturbance, change in mean score from baseline to last week of treatment	12 weeks
Modified Tardieu and clonus over ankle joints	12 weeks
Spasticity and spasms on a 0-10 NRS	12 weeks
Health related quality of life S-TOPS	12 weeks
Global Impression of Change	12 weeks
Pain relief of overall pain and at-and below level pain	12 weeks
allodynia(touch and cold)	12 weeks
Pain symptoms evaluated by NPSI	12 weeks
pain impact on activities, sleep and mood	12 weeks
effect on unpleasantness	12 weeks
escape medication	12 weeks
Insomnia Severity Index	12 weeks
anxiety(GAD-10)	12 weeks
depression(MDI)	12 weeks
NNT for 33% and 50% pain reduction	12 weeks
Combined spasticity and pain score (CPSS)	12 weeks
Numbers of responders (33% pain reduction) in those with and without allodynia/hyperalgesia and those with different pain symptoms (NPSI)	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blindness is assessed by asking the patients and treating physician which treatment they believed they recieved and the reason for this		12 weeks
Number of patients with adverse events and number, type and severity of adverse events.	Adverse events are assessed using open-ended questions both during and after treatment period. SAE reporting will be performed according to GCP and regulatory requirements.	12 weeks

Collaborators and Investigators

• Sponsor: Danish Pain Research Center
• Collaborators: Glostrup University Hospital, Copenhagen; Spinal Cord Injury Centre of Western Denmark; Epitech Group SRL, Italy
• Investigators: Principal Investigator: Sven R. Andresen, MD, Spinal Cord Injury Centre of Western Denmark

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 8, 2013
• First Submitted That Met QC Criteria: May 9, 2013
• First Posted (Estimate): May 10, 2013

Study Record Updates

• Last Update Posted (Estimate): October 20, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Neuropathic pain following spinal cord injury
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Neuralgia; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: Normast-2013