220
Participants
Start Date
December 11, 2024
Primary Completion Date
October 15, 2026
Study Completion Date
November 1, 2026
Melatonin 10 MG
2 Melatonin tablets (each 5 mg) once daily (egual 10 mg/day) in the evening, 30 min. before going to sleep for 6 weeks. If a participant experiences an adverse event deemed related to the study medication of grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 the dose will be reduced to 5 mg/day.
Placebo
2 placebo tablets once daily in the evening, 30 min. before going to sleep for 6 weeks. If a participant experiences an adverse event deemed related to the study medication of grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 the dose will be reduced to 1 tablet.
RECRUITING
Pain Center, University Hospital Odense, Odense
Collaborators (1)
University of Southern Denmark
OTHER
T&W Engineering A/S
INDUSTRY
University of Aarhus
OTHER
Region of Southern Denmark
OTHER
Erasmus Medical Center
OTHER
Odense University Hospital
OTHER