Clinical trial NCT01851499: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Spinal Cord Injury
Keywords: Neuropathic pain following spinal cord injury
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
Collaborators: name: Spinal Cord Injury Centre of Western Denmark
name: Glostrup University Hospital, Copenhagen
name: Epitech Group SRL, Italy
First posted: 2013-05-10
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in mean pain intensity on a 0-10 numerical rating scale from baseline week to last week of treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Spasticity/spasms and sleep disturbance, change in mean score from baseline to last week of treatment
timeFrame: 12 weeks
measure: Modified Tardieu and clonus over ankle joints
timeFrame: 12 weeks
measure: Spasticity and spasms on a 0-10 NRS
timeFrame: 12 weeks
measure: Health related quality of life S-TOPS
timeFrame: 12 weeks
measure: Global Impression of Change
timeFrame: 12 weeks
measure: Pain relief of overall pain and at-and below level pain
timeFrame: 12 weeks
measure: allodynia(touch and cold)
timeFrame: 12 weeks
measure: Pain symptoms evaluated by NPSI
timeFrame: 12 weeks
measure: pain impact on activities, sleep and mood
timeFrame: 12 weeks
measure: effect on unpleasantness
timeFrame: 12 weeks
measure: escape medication
timeFrame: 12 weeks
measure: Insomnia Severity Index
timeFrame: 12 weeks
measure: anxiety(GAD-10)
timeFrame: 12 weeks
measure: depression(MDI)
timeFrame: 12 weeks
measure: NNT for 33% and 50% pain reduction
timeFrame: 12 weeks
measure: Combined spasticity and pain score (CPSS)
timeFrame: 12 weeks
measure: Numbers of responders (33% pain reduction) in those with and without allodynia/hyperalgesia and those with different pain symptoms (NPSI)
timeFrame: 12 weeks
Other outcomes:
measure: Blindness is assessed by asking the patients and treating physician which treatment they believed they recieved and the reason for this
timeFrame: 12 weeks
measure: Number of patients with adverse events and number, type and severity of adverse events.
timeFrame: 12 weeks
Locations:
city: Hornbaek
country: Denmark
facility: Department of Spinal Cord Injuries
city: Viborg
country: Denmark
facility: Spinal Cord Injury Centre of Western Denmark
Study officials:
affiliation: Spinal Cord Injury Centre of Western Denmark
name: Sven R. Andresen, MD
role: PRINCIPAL_INVESTIGATOR
References: