Neuropathic Pain, Spinal Cord Injury
Conditions
Keywords
Neuropathic pain following spinal cord injury
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.
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.
Interventions
DIETARY_SUPPLEMENTUltramicronized PEA (Normast)
600 mg
Sponsors
Spinal Cord Injury Centre of Western Denmark
Glostrup University Hospital, Copenhagen
Epitech Group SRL, Italy
Danish Pain Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean pain intensity on a 0-10 numerical rating scale from baseline week to last week of treatment | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Pain relief of overall pain and at-and below level pain | 12 weeks |
| allodynia(touch and cold) | 12 weeks |
| Pain symptoms evaluated by NPSI | 12 weeks |
| pain impact on activities, sleep and mood | 12 weeks |
| Combined spasticity and pain score (CPSS) | 12 weeks |
| Numbers of responders (33% pain reduction) in those with and without allodynia/hyperalgesia and those with different pain symptoms (NPSI) | 12 weeks |
| effect on unpleasantness | 12 weeks |
| escape medication | 12 weeks |
| Insomnia Severity Index | 12 weeks |
| anxiety(GAD-10) | 12 weeks |
| depression(MDI) | 12 weeks |
| NNT for 33% and 50% pain reduction | 12 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Denmark
Outcome results
None listed