Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Phase 4 Completed 12 enrolled US Department of Veterans Affairs Stanford University · collab Takeda · collab

RandomizedCrossoverTriple-blindTreatment

Summary

The purpose of this study is to determine if replacing melatonin function with a melatonin agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia) helps to alleviate self-reported sleep disruption.

Timeline

Start: 2007-07
Primary completion: 2010-12
Completion: 2011-07

Outcome

Missed primary endpoint

registry MEDIAN Ramelteon: 72.3 (20.7 to 92.3) Minutes MEDIAN Placebo: 76.5 (24.0 to 117) Minutes NCT00507546 ↗

registry analysis (superiority or other test); Ramelteon vs Placebo; p = 0.70; Friedman NCT00507546 ↗

Publications

Results Zeitzer JM, Ku B, Ota D, Kiratli BJ. Randomized controlled trial of pharmacological replacement of melatonin for sleep disruption in individuals with tetraplegia. J Spinal Cord Med. 2014 Jan;37(1):46-53. doi: 10.1179/2045772313Y.0000000099. Epub 2013 Oct 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ramelteon	Unknown	8 mg	—