The effects of palmitoylethanolamide (PEA) on pain and brain activity.

Phase 1

• Conditions: Persistent orofacial/ trigeminal neuropathic pain; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis); Neurological - Studies of the normal brain and nervous system; Neurological - Other neurological disorders

• Registration Number: ACTRN12618001637235
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-03
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Subjects with a diagnosis of orofacial / trigeminal neuropathic pain for longer than 3 months duration
Aged over 18 years old
Willingness to give written informed consent, willingness to complete a magnetic resonance imaging study, complete various questionnaires and to have a blood sample taken

Exclusion Criteria

Taking daily analgesic medications such as aspirin, ibuprofen, gabapentin, serotonin reuptake inhibitors, anti-depressants for any conditions within 24 hours of study initiation.
Claustrophobia
Standard MRI exclusion criteria such as the presence of a cardiac pacemaker, artificial heart valve, blood vessel stents, aneurysm clips, cochlear implants, prosthetic devices, magnetically activated implant or device and pregnancy.
History of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in on-going pain intensity indicated on visual analogue scale.[3 times a day for 7 weeks post-treatment]