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| Name | Class |
|---|---|
| Spinal Cord Injury Centre of Western Denmark | OTHER |
| Glostrup University Hospital, Copenhagen | OTHER |
| Epitech Group SRL, Italy | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultramicronized PEA (Normast) | Experimental | Normast is ultramicronized Palmitoylethanolamide (PEA) classified as "Dietary foods for special medical purposes". |
|
| Microgranules | Placebo Comparator | Same as Normast, without active component. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultramicronized PEA (Normast) | Dietary Supplement | 600 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean pain intensity on a 0-10 numerical rating scale from baseline week to last week of treatment | 12 weeks |
| Measure | Description | 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven R. Andresen, MD | Spinal Cord Injury Centre of Western Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Spinal Cord Injuries | Hornbæk | 3100 | Denmark | |||
| Spinal Cord Injury Centre of Western Denmark |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| 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 |
| 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 |
| 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 |
| 12 weeks |
| Viborg |
| 8800 |
| Denmark |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |