Neuropathic PainNCT01851499
Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain
A study testing Ultramicronized PEA (Normast) in people with Neuropathic Pain and Spinal Cord Injury, run by Danish Pain Research Center at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Spinal Cord Injury
- What is being tested?
- Ultramicronized PEA (Normast)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Spinal Cord Injuries
Hornbæk, 3100
Spinal Cord Injury Centre of Western Denmark
Viborg, 8800
About this study
Official title: Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain: a Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Study
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.
Read the 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.
- Conditions
- Neuropathic Pain, Spinal Cord Injury
- Being tested
- Ultramicronized PEA (Normast)
- Keywords
- Neuropathic pain following spinal cord injury
- Medical subject headings
- Neuralgia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultramicronized PEA (Normast)Dietary supplement
600 mg
| Study group | Role | What they receive |
|---|---|---|
| Ultramicronized PEA (Normast) | Experimental | Normast is ultramicronized Palmitoylethanolamide (PEA) classified as "Dietary foods for special medical purposes". Receives: Dietary Supplement: Ultramicronized PEA (Normast) |
| Microgranules | Placebo comparator | Same as Normast, without active component. Receives: Dietary Supplement: Ultramicronized PEA (Normast) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean pain intensity on a 0-10 numerical rating scale from baseline week to last week of treatment
Measured: 12 weeks
Secondary outcomes (17)
Spasticity/spasms and sleep disturbance, change in mean score from baseline to last week of treatment
Measured: 12 weeks
Modified Tardieu and clonus over ankle joints
Measured: 12 weeks
Spasticity and spasms on a 0-10 NRS
Measured: 12 weeks
Health related quality of life S-TOPS
Measured: 12 weeks
Global Impression of Change
Measured: 12 weeks
Pain relief of overall pain and at-and below level pain
Measured: 12 weeks
allodynia(touch and cold)
Measured: 12 weeks
Pain symptoms evaluated by NPSI
Measured: 12 weeks
pain impact on activities, sleep and mood
Measured: 12 weeks
effect on unpleasantness
Measured: 12 weeks
escape medication
Measured: 12 weeks
Insomnia Severity Index
Measured: 12 weeks
anxiety(GAD-10)
Measured: 12 weeks
depression(MDI)
Measured: 12 weeks
NNT for 33% and 50% pain reduction
Measured: 12 weeks
Combined spasticity and pain score (CPSS)
Measured: 12 weeks
Numbers of responders (33% pain reduction) in those with and without allodynia/hyperalgesia and those with different pain symptoms (NPSI)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Spinal Cord Injury Centre of Western Denmark, Glostrup University Hospital, Copenhagen, Epitech Group SRL, Italy
- Responsible party
- Sponsor
- Investigators
- Sven R. Andresen, MD, Principal investigator, Spinal Cord Injury Centre of Western Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851499
- Sponsor's protocol ID
- Normast-2013
- Status last verified
- Oct 2015
- First submitted
- 8 May 2013
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain: a Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Study
- ClinicalTrials.gov ID
- NCT01851499
- Acronym / sponsor ID
- Normast-2013
- Conditions
- Neuropathic Pain, Spinal Cord Injury
- Keywords
- Neuropathic pain following spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Collaborators
- Spinal Cord Injury Centre of Western Denmark, Glostrup University Hospital, Copenhagen, Epitech Group SRL, Italy
- Study start
- May 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultramicronized PEA (Normast) | Experimental | Dietary Supplement: Ultramicronized PEA (Normast)Normast is ultramicronized Palmitoylethanolamide (PEA) classified as "Dietary foods for special medical purposes". |
| Microgranules | Placebo comparator | Dietary Supplement: Ultramicronized PEA (Normast)Same as Normast, without active component. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultramicronized PEA (Normast)600 mg | Dietary supplement | Microgranules, Ultramicronized PEA (Normast) |
Primary outcome
Change in mean pain intensity on a 0-10 numerical rating scale from baseline week to last week of treatment
Time frame: 12 weeks
17 secondary outcomes
Spasticity/spasms and sleep disturbance, change in mean score from baseline to last week of treatment
Time frame: 12 weeks
Modified Tardieu and clonus over ankle joints
Time frame: 12 weeks
Spasticity and spasms on a 0-10 NRS
Time frame: 12 weeks
Health related quality of life S-TOPS
Time frame: 12 weeks
Global Impression of Change
Time frame: 12 weeks
Pain relief of overall pain and at-and below level pain
Time frame: 12 weeks
allodynia(touch and cold)
Time frame: 12 weeks
Pain symptoms evaluated by NPSI
Time frame: 12 weeks
pain impact on activities, sleep and mood
Time frame: 12 weeks
effect on unpleasantness
Time frame: 12 weeks
escape medication
Time frame: 12 weeks
Insomnia Severity Index
Time frame: 12 weeks
anxiety(GAD-10)
Time frame: 12 weeks
depression(MDI)
Time frame: 12 weeks
NNT for 33% and 50% pain reduction
Time frame: 12 weeks
Combined spasticity and pain score (CPSS)
Time frame: 12 weeks
Numbers of responders (33% pain reduction) in those with and without allodynia/hyperalgesia and those with different pain symptoms (NPSI)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
Related trials for Neuropathic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven R. Andresen, MD principal investigator
Spinal Cord Injury Centre of Western Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultramicronized PEA (Normast) in people with Neuropathic Pain and Spinal Cord Injury, run by Danish Pain Research Center at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean pain intensity on a 0-10 numerical rating scale from baseline week to last week of treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.