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Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

Primary Purpose

Neuropathic Pain, Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ultramicronized PEA (Normast)
Sponsored by
Danish Pain Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic pain following spinal cord injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Spinal Cord Injuries
  • Spinal Cord Injury Centre of Western Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ultramicronized PEA (Normast)

Microgranules

Arm Description

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

Same as Normast, without active component.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 8, 2013
Last Updated
October 19, 2015
Sponsor
Danish Pain Research Center
Collaborators
Spinal Cord Injury Centre of Western Denmark, Glostrup University Hospital, Copenhagen, Epitech Group SRL, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01851499
Brief Title
Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain
Official Title
Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain: a Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danish Pain Research Center
Collaborators
Spinal Cord Injury Centre of Western Denmark, Glostrup University Hospital, Copenhagen, Epitech Group SRL, Italy

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Spinal Cord Injury
Keywords
Neuropathic pain following spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultramicronized PEA (Normast)
Arm Type
Experimental
Arm Description
Normast is ultramicronized Palmitoylethanolamide (PEA) classified as "Dietary foods for special medical purposes".
Arm Title
Microgranules
Arm Type
Placebo Comparator
Arm Description
Same as Normast, without active component.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ultramicronized PEA (Normast)
Intervention Description
600 mg
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Spasticity/spasms and sleep disturbance, change in mean score from baseline to last week of treatment
Time Frame
12 weeks
Title
Modified Tardieu and clonus over ankle joints
Time Frame
12 weeks
Title
Spasticity and spasms on a 0-10 NRS
Time Frame
12 weeks
Title
Health related quality of life S-TOPS
Time Frame
12 weeks
Title
Global Impression of Change
Time Frame
12 weeks
Title
Pain relief of overall pain and at-and below level pain
Time Frame
12 weeks
Title
allodynia(touch and cold)
Time Frame
12 weeks
Title
Pain symptoms evaluated by NPSI
Time Frame
12 weeks
Title
pain impact on activities, sleep and mood
Time Frame
12 weeks
Title
effect on unpleasantness
Time Frame
12 weeks
Title
escape medication
Time Frame
12 weeks
Title
Insomnia Severity Index
Time Frame
12 weeks
Title
anxiety(GAD-10)
Time Frame
12 weeks
Title
depression(MDI)
Time Frame
12 weeks
Title
NNT for 33% and 50% pain reduction
Time Frame
12 weeks
Title
Combined spasticity and pain score (CPSS)
Time Frame
12 weeks
Title
Numbers of responders (33% pain reduction) in those with and without allodynia/hyperalgesia and those with different pain symptoms (NPSI)
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Blindness is assessed by asking the patients and treating physician which treatment they believed they recieved and the reason for this
Time Frame
12 weeks
Title
Number of patients with adverse events and number, type and severity of adverse events.
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven R. Andresen, MD
Organizational Affiliation
Spinal Cord Injury Centre of Western Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Spinal Cord Injuries
City
Hornbaek
ZIP/Postal Code
3100
Country
Denmark
Facility Name
Spinal Cord Injury Centre of Western Denmark
City
Viborg
ZIP/Postal Code
8800
Country
Denmark

12. IPD Sharing Statement

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Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

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