Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

NCT01851499 | Completed

• 1 other identifier: Normast-2013
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

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.

Conditions

Neuropathic Pain; Spinal Cord Injury

Keywords

Neuropathic pain following spinal cord injury

Outcome Measures

Primary Outcomes (1)

• Change in mean pain intensity on a 0-10 numerical rating scale from baseline week to last week of treatment

  12 weeks

Secondary Outcomes (17)

• 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

Other Outcomes (2)

• Blindness is assessed by asking the patients and treating physician which treatment they believed they recieved and the reason for this

  12 weeks

• Number of patients with adverse events and number, type and severity of adverse events.

  12 weeks

Study Arms (2)

Ultramicronized PEA (Normast)

EXPERIMENTAL

Normast is ultramicronized Palmitoylethanolamide (PEA) classified as "Dietary foods for special medical purposes".

Dietary Supplement: Ultramicronized PEA (Normast)

Microgranules

PLACEBO COMPARATOR

Same as Normast, without active component.

Dietary Supplement: Ultramicronized PEA (Normast)

Interventions

Ultramicronized PEA (Normast) DIETARY_SUPPLEMENT

600 mg

Microgranules; Ultramicronized PEA (Normast)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Pain Research Center: lead
• Spinal Cord Injury Centre of Western Denmark: collaborator
• Glostrup University Hospital, Copenhagen: collaborator
• Epitech Group SRL, Italy: collaborator

Study Sites (2)

Department of Spinal Cord Injuries

Hornbæk, 3100, Denmark

Location

Spinal Cord Injury Centre of Western Denmark

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sven R. Andresen, MD

  Spinal Cord Injury Centre of Western Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 10, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

DK (2)