Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia; Spinal Cord Injury; Tetraplegia; Sleep Disorders
Intervention: Ramelteon (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Jamie Zeitzer, PhD, Principal Investigator, Affiliation: VA Palo Alto Health Care System
Overall contact:
Ban Ku, BA, Phone: (650) 849-1971, Email: bankusan@gmail.com
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.
Clinical Details
Official title: Melatonin Replacement for Treatment of Sleep Disruption
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Improvement in subjective and objective sleep parameters
Secondary outcome: Improvement in daytime alertness and overall quality of life.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age 18 years or older, male or female veterans of any racial or ethnic group
2. Neurologically complete (Frankel A or B) damage to the lower (C4-C8) cervical spinal
cord
3. Absence of melatonin production
4. Time since SCI is greater than 6 months [no cases of acute SCI]
5. Subjective complaint of sleep disruption
Exclusion Criteria:
1. 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
2. Hepatic dysfunction
3. Concomitant use of over-the-counter melatonin
4. Pregnancy or breast feeding
5. Currently or have within the past six months met DSM-IV criteria for drug or alcohol
abuse or dependence or AUDIT score >19
6. Acute illness or unstable chronic illness. Use of continuous positive airway
pressure (CPAP) for treatment of sleep apnea is acceptable.
7. No travel across three or more time zones within three weeks or during the protocol
8. Illiterate or unable to read or write English or are judged by the investigator to be
unable or unlikely to follow the study protocol
Locations and Contacts
Ban Ku, BA, Phone: (650) 849-1971, Email: bankusan@gmail.com
VA Palo Alto Health Care System, Palo Alto, California 94304-1290, United States; Recruiting
Ban Ku, BA, Phone: 650-849-1971, Email: bankusan@gmail.com
Beatrice J. Kiratli, PhD, Sub-Investigator
Jamie Zeitzer, PhD, Principal Investigator
Doug Ota, MD, Sub-Investigator
Additional Information
Starting date: July 2007
Ending date: May 2011
Last updated: August 19, 2009
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