Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851499
• Other study ID #: Normast-2013
• Status: Completed
• Phase: N/A
• First received: May 8, 2013
• Last updated: October 19, 2015
• Start date: May 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Danish Pain Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Dietary Supplement:
• Ultramicronized PEA (Normast)
600 mg

Locations

Country	Name	City	State
Denmark	Department of Spinal Cord Injuries	Hornbaek
Denmark	Spinal Cord Injury Centre of Western Denmark	Viborg

Sponsors (4)

Lead Sponsor	Collaborator
Danish Pain Research Center	Epitech Group SRL, Italy, Glostrup University Hospital, Copenhagen, Spinal Cord Injury Centre of Western Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blindness is assessed by asking the patients and treating physician which treatment they believed they recieved and the reason for this		12 weeks	No
Other	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	No
Primary	Change in mean pain intensity on a 0-10 numerical rating scale from baseline week to last week of treatment		12 weeks	No
Secondary	Spasticity/spasms and sleep disturbance, change in mean score from baseline to last week of treatment		12 weeks	No
Secondary	Modified Tardieu and clonus over ankle joints		12 weeks	No
Secondary	Spasticity and spasms on a 0-10 NRS		12 weeks	No
Secondary	Health related quality of life S-TOPS		12 weeks	No
Secondary	Global Impression of Change		12 weeks	No
Secondary	Pain relief of overall pain and at-and below level pain		12 weeks	No
Secondary	allodynia(touch and cold)		12 weeks	No
Secondary	Pain symptoms evaluated by NPSI		12 weeks	No
Secondary	pain impact on activities, sleep and mood		12 weeks	No
Secondary	effect on unpleasantness		12 weeks	No
Secondary	escape medication		12 weeks	No
Secondary	Insomnia Severity Index		12 weeks	No
Secondary	anxiety(GAD-10)		12 weeks	No
Secondary	depression(MDI)		12 weeks	No
Secondary	NNT for 33% and 50% pain reduction		12 weeks	No
Secondary	Combined spasticity and pain score (CPSS)		12 weeks	No
Secondary	Numbers of responders (33% pain reduction) in those with and without allodynia/hyperalgesia and those with different pain symptoms (NPSI)		12 weeks	No