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NCT Number: NCT01851499

Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Spinal Cord Injuries, Hornbæk, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultramicronized PEA (Normast)

Dietary Supplement

600 mg

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. Spasticity/spasms and sleep disturbance, change in mean score from baseline to last week of treatment

    Time frame: 12 weeks

  2. Modified Tardieu and clonus over ankle joints

    Time frame: 12 weeks

  3. Spasticity and spasms on a 0-10 NRS

    Time frame: 12 weeks

  4. Health related quality of life S-TOPS

    Time frame: 12 weeks

  5. Global Impression of Change

    Time frame: 12 weeks

  6. Pain relief of overall pain and at-and below level pain

    Time frame: 12 weeks

  7. allodynia(touch and cold)

    Time frame: 12 weeks

  8. Pain symptoms evaluated by NPSI

    Time frame: 12 weeks

  9. pain impact on activities, sleep and mood

    Time frame: 12 weeks

  10. effect on unpleasantness

    Time frame: 12 weeks

  11. escape medication

    Time frame: 12 weeks

  12. Insomnia Severity Index

    Time frame: 12 weeks

  13. anxiety(GAD-10)

    Time frame: 12 weeks

  14. depression(MDI)

    Time frame: 12 weeks

  15. NNT for 33% and 50% pain reduction

    Time frame: 12 weeks

  16. Combined spasticity and pain score (CPSS)

    Time frame: 12 weeks

  17. Numbers of responders (33% pain reduction) in those with and without allodynia/hyperalgesia and those with different pain symptoms (NPSI)

    Time frame: 12 weeks

Other outcomes

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Danish Pain Research Center

Other

Collaborators

  • Epitech Group SRL, Italy
  • Glostrup University Hospital, Copenhagen
  • Spinal Cord Injury Centre of Western Denmark

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 10, 2013
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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