Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

Danish Pain Research Center

Status

Completed

Conditions

Neuropathic Pain

Spinal Cord Injury

Treatments

Dietary Supplement: Ultramicronized PEA (Normast)

Study type

Interventional

Funder types

Other

Identifiers

NCT01851499

Normast-2013

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.