Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

This study is currently recruiting participants.

Verified by Department of Veterans Affairs, August 2009

First Received: July 25, 2007 Last Updated: August 19, 2009 History of Changes

Sponsors and Collaborators:	Department of Veterans Affairs Stanford University Takeda Global Research & Development Center, Inc.
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00507546

Purpose

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.

Condition	Intervention	Phase
Insomnia Spinal Cord Injury Tetraplegia Sleep Disorders	Drug: Ramelteon Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Melatonin Replacement for Treatment of Sleep Disruption

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders Spinal Cord Injuries

Drug Information available for: Melatonin Ramelteon

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Improvement in subjective and objective sleep parameters [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement in daytime alertness and overall quality of life. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2007
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Ramelteon	Drug: Ramelteon 8 mg nightly
2: Placebo Comparator Placebo	Drug: Placebo Nightly 8mg of placebo (same appearance as ramelteon)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 SCI]
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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507546

Contacts

Contact: Ban Ku, BA	(650) 849-1971	bankusan@gmail.com
Contact: Jamie Zeitzer, PhD	(650) 493-5000 ext 62410	jamie.zeitzer@va.gov

Locations

United States, California
VA Palo Alto Health Care System	Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Ban Ku, BA 650-849-1971 bankusan@gmail.com
Sub-Investigator: Beatrice J. Kiratli, PhD
Principal Investigator: Jamie Zeitzer, PhD
Sub-Investigator: Doug Ota, MD

Sponsors and Collaborators

Department of Veterans Affairs

Stanford University

Takeda Global Research & Development Center, Inc.

Investigators

Principal Investigator:

Jamie Zeitzer, PhD

VA Palo Alto Health Care System

More Information

Publications:

Lavie P. Melatonin: role in gating nocturnal rise in sleep propensity. J Biol Rhythms. 1997 Dec;12(6):657-65. Review.

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.

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.

Biering-Sorensen F, Biering-Sorensen M, Hilden J. Reproducibility of Nordic Sleep Questionnaire in spinal cord injured. Paraplegia. 1994 Nov;32(11):780-6.

Responsible Party:	Department of Veterans Affairs ( Zeitzer, Jamie - Principal Investigator )
Study ID Numbers:	B6010R, 06-038R
Study First Received:	July 25, 2007
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00507546 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

sleep
melatonin
spinal cord injury
insomnia
tetraplegia

Study placed in the following topic categories:

Antioxidants
Spinal Cord Diseases
Wounds and Injuries
Central Nervous System Depressants
Sleep Disorders
Central Nervous System Diseases
Disorders of Environmental Origin
Quadriplegia

Trauma, Nervous System
Paralysis
Spinal Cord Injuries
Signs and Symptoms
Mental Disorders
Neurologic Manifestations
Melatonin

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Spinal Cord Diseases
Physiological Effects of Drugs
Nervous System Diseases
Wounds and Injuries
Central Nervous System Depressants
Sleep Disorders
Central Nervous System Diseases
Disorders of Environmental Origin
Quadriplegia

Trauma, Nervous System
Protective Agents
Pharmacologic Actions
Paralysis
Spinal Cord Injuries
Signs and Symptoms
Mental Disorders
Therapeutic Uses
Neurologic Manifestations
Melatonin
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 03, 2009