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Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT01851499
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : October 20, 2015
Sponsor:
Collaborators:
Spinal Cord Injury Centre of Western Denmark
Glostrup University Hospital, Copenhagen
Epitech Group SRL, Italy
Information provided by (Responsible Party):
Danish Pain Research Center

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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Spinal Cord Injury Dietary Supplement: Ultramicronized PEA (Normast) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain: a Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Study
Study Start Date : May 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ultramicronized PEA (Normast)
Normast is ultramicronized Palmitoylethanolamide (PEA) classified as "Dietary foods for special medical purposes".
Dietary Supplement: Ultramicronized PEA (Normast)
600 mg

Placebo Comparator: Microgranules
Same as Normast, without active component.
Dietary Supplement: Ultramicronized PEA (Normast)
600 mg




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851499


Locations
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Denmark
Department of Spinal Cord Injuries
Hornbaek, Denmark, 3100
Spinal Cord Injury Centre of Western Denmark
Viborg, Denmark, 8800
Sponsors and Collaborators
Danish Pain Research Center
Spinal Cord Injury Centre of Western Denmark
Glostrup University Hospital, Copenhagen
Epitech Group SRL, Italy
Investigators
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Principal Investigator: Sven R. Andresen, MD Spinal Cord Injury Centre of Western Denmark

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Responsible Party: Danish Pain Research Center
ClinicalTrials.gov Identifier: NCT01851499     History of Changes
Other Study ID Numbers: Normast-2013
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by Danish Pain Research Center:
Neuropathic pain following spinal cord injury

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Trauma, Nervous System
Neuralgia
Central Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms