Clinical trial of melatonin for the treatment of neuropathic pai

Not Applicable

• Conditions: Chronic peripheral neuropathic pain; Nervous System Diseases

• Registration Number: ISRCTN16215617
• Lead Sponsor: Physicians' Services Incorporated Foundation

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36170003/ (added 29/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-04
• Last Update Posted: 10 October 2022
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Score of 4 or higher on the DN4 interview, a validated questionnaire that distinguishes between neuropathic and non-neuropathic pain.14 As indicated, investigations will be done to confirm NP diagnosis including, but not limited to, nerve conduction studies and electromyography.
2. Daily pain (=4/10) for at least 3 months
3. AST/ALT =120% upper limit of normal
4. Creatinine clearance =60 ml/min
5. Glycosylated hemoglobin =9.5%
6. Necessary abilities, visual acuity, and language skills for questionnaire completion and phone communication with nurses

Exclusion Criteria

1. Major organ system disease
2. Cardiovascular autonomic neuropathy
3. Trigeminal neuralgia, complex regional pain syndrome or central neuropathic pain
4. Moderate to severe sedation or ataxia due to other required concomitant drugs
5. Allergy/hypersensitivity to study medications or any components in the study drug formulations or their containers
6. Seizure disorder
7. Other painful condition >50% as severe as their NP
8. A major, poorly controlled, psychiatric disorder, depression or suicidal ideation, or active substance use disorder
9. History of angioedema
10. Candidates who live alone and cannot assure daily contact with a friend, family member, or caregiver
11. Women of childbearing potential who will not receive a highly effective form of contraception (total abstinence, hormonal birth control methods, intrauterine devices, confirmed successful vasectomy of partner, double-barrier methods such as condom/diaphragm, etc.) and/or a positive pregnancy test at baseline (If a study participant becomes pregnant, she must stop using study medications immediately and will be withdrawn from the study)
12. Women who are breastfeeding or who plan to breastfeed
13. Regular daily administration of opioids at a dose greater than 90 mg morphine equivalents
14. Lack of a primary care physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean daily pain measured using a 0-10 numerical rating scale with 0 = no pain”, 10 = worst pain imaginable”, averaged over the MTD fixed-dose week” (days 22-28) of each period