Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

This study has been completed.

First Received on July 25, 2007. Last Updated on December 13, 2011 History of Changes

Sponsor:	Department of Veterans Affairs
Collaborators:	Stanford University Takeda Global Research & Development Center, Inc.
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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 ]

Enrollment:	60
Study Start Date:	July 2007
Study Completion Date:	July 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Ramelteon	Drug: Ramelteon 8 mg nightly Other Name: Rozerem
Placebo Comparator: 2 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

Locations

United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290

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

No publications provided

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00507546 History of Changes
Other Study ID Numbers:	B6010R, 06-038R
Study First Received:	July 25, 2007
Last Updated:	December 13, 2011
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

sleep
melatonin
spinal cord injury
insomnia
tetraplegia

Additional relevant MeSH terms:

Quadriplegia
Sleep Disorders
Parasomnias
Spinal Cord Injuries
Sleep Initiation and Maintenance Disorders
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System

Wounds and Injuries
Sleep Disorders, Intrinsic
Dyssomnias
Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012