Status:
COMPLETED
Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain
Lead Sponsor:
Danish Pain Research Center
Collaborating Sponsors:
Spinal Cord Injury Centre of Western Denmark
Glostrup University Hospital, Copenhagen
Conditions:
Neuropathic Pain
Spinal Cord Injury
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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. Me...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01851499
Start Date
May 1 2013
End Date
October 1 2015
Last Update
October 20 2015
Active Locations (2)
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1
Department of Spinal Cord Injuries
Hornbæk, Denmark, 3100
2
Spinal Cord Injury Centre of Western Denmark
Viborg, Denmark, 8800