Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neuropathic Pain, Spinal Cord Injury

Intervention / Treatment
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* Dietary Supplement: Ultramicronized PEA (Normast)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultramicronized PEA (Normast)<br>Normast is ultramicronized Palmitoylethanolamide (PEA) classified as Dietary foods for special medical purposes. | Dietary Supplement: Ultramicronized PEA (Normast)<br>* 600 mg<br>|
| Placebo Comparator: Microgranules<br>Same as Normast, without active component. | Dietary Supplement: Ultramicronized PEA (Normast)<br>* 600 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic pain following spinal cord injury