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...
Date First Received: July 25, 2007
Last Updated: September 12, 2008
Verified by: Department of Veterans Affairs, July 2008
Clinical Trial Phase: Phase 4 | Start Date: July 2007
Overall Status: Recruiting
Estimated Enrollment: 60
Brief Summary
Official Title: “Melatonin Replacement for Treatment of Sleep Disruption”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Study Primary Completion Date: May 2011
Intervention(s) in this Clinical Trial
- Drug: Ramelteon
- 8 mg nightly
- Drug: Placebo
- Nightly 8mg of placebo (same appearance as ramelteon)
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Ramelteon
- Placebo Comparator: 2
- Placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Improvement in subjective and objective sleep parameters
- Time Frame: 10 weeks
Safety Issue?: No
- Time Frame: 10 weeks
Secondary Measures
- Improvement in daytime alertness and overall quality of life.
- Time Frame: 10 weeks
Safety Issue?: No
- Time Frame: 10 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: VA Palo Alto Health Care System
Overall Clinical Trial Officials and Contacts
Jamie M Zeitzer, PhD Principal Investigator VAPAHCS/Stanford University
Overall Contact: Ban Ku, BA 650-849-1971 bankusan@gmail.com
Related Publications
References
Biering-Sorensen F, Biering-Sorensen M, Hilden J. Reproducibility of Nordic Sleep Questionnaire in spinal cord injured. Paraplegia. 1994 Nov;32(11):780-6.
Zeitzer JM, Ayas NT, Shea SA, Brown R, Czeisler CA. Absence of detectable melatonin and preservation of cortisol and thyrotropin rhythms in tetraplegia. J Clin Endocrinol Metab. 2000 Jun;85(6):2189-96.
Scheer FA, Zeitzer JM, Ayas NT, Brown R, Czeisler CA, Shea SA. Reduced sleep efficiency in cervical spinal cord injury; association with abolished night time melatonin secretion. Spinal Cord. 2006 Feb;44(2):78-81.
McEvoy RD, Mykytyn I, Sajkov D, Flavell H, Marshall R, Antic R, Thornton AT. Sleep apnoea in patients with quadriplegia. Thorax. 1995 Jun;50(6):613-9.
Lavie P. Melatonin: role in gating nocturnal rise in sleep propensity. J Biol Rhythms. 1997 Dec;12(6):657-65. Review.
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00507546
Study ID Number: B6010R
ClinicalTrials.gov Identifier: NCT00507546
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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