Phase 4 N=8 Randomized Triple-blind Treatment

Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Insomnia · Spinal Cord Injury · Tetraplegia · Sleep Disorders

Bottom Line

View on ClinicalTrials.gov: NCT00507546 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Amount of Wakefulness After Sleep Onset (WASO) — 72.3; 76.5 Minutes — p=0.70

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ramelteon (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Amount of Wakefulness After Sleep Onset (WASO)	72.3; 76.5	0.70
SECONDARY Change in Subjective Morning Alertness	2.86; 3.14	0.35

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.

Eligibility Criteria

Inclusion Criteria

Age 18 years or older, male or female veterans of any racial or ethnic group
Neurologically complete (Frankel A or B) damage to the lower (C4-C8) cervical spinal cord
Absence of melatonin production
Time since SCI is greater than 6 months [no cases of acute spinal cord injury]
Subjective complaint of sleep disruption

Exclusion Criteria

Current use of fluvoxamine (Luvox , antidepressant), rifampin (antimycobacterial), ketoconazole (Nizoral , antifungal), or fluconazole (Diflucan , antifungal) [these interact with the same liver enzyme that is the primary metabolizer of ramelteon]; use of sleep medications is okay
Hepatic dysfunction
Concomitant use of over-the-counter melatonin
Pregnancy or breast feeding
Currently or have within the past six months met DSM-IV (Diagnosis and Statistical Manual IV) criteria for drug or alcohol abuse or dependence or AUDIT score >19
Acute illness or unstable chronic illness. Use of continuous positive airway pressure (CPAP) for treatment of sleep apnea is acceptable.
No travel across three or more time zones within three weeks or during the protocol
Illiterate or unable to read or write English or are judged by the investigator to be unable or unlikely to follow the study protocol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00507546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.