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Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00507546
First Posted: July 26, 2007
Last Update Posted: May 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Stanford University
Takeda
Information provided by (Responsible Party):
VA Office of Research and Development
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Melatonin Replacement for Treatment of Sleep Disruption

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Amount of Wakefulness After Sleep Onset (WASO) [ Time Frame: 10 weeks ]
    Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment


Secondary Outcome Measures:
  • Change in Subjective Morning Alertness [ Time Frame: 10 weeks ]
    Measured as the median of the average morning alertness (measured from 1-7 on the Stanford Sleepiness Scale, a Likert-like scale in which higher values are lower alertness) of the three weeks of either placebo or ramelteon treatment


Enrollment: 12
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: Ramelteon then placebo
8 mg nightly ramelteon for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of nightly placebo (cross-over)
Drug: Ramelteon
8 mg nightly
Other Name: Rozerem
Experimental: Placebo then ramelteon
placebo nightly for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of 8 mg nightly ramelteon (cross-over)
Drug: Placebo
Nightly 8mg of placebo (same appearance as ramelteon)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507546


Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
VA Office of Research and Development
Stanford University
Takeda
Investigators
Principal Investigator: Jamie M. Zeitzer, PhD VA Palo Alto Health Care System
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00507546     History of Changes
Other Study ID Numbers: B6010-R
06-038R ( Other Grant/Funding Number: VA )
First Submitted: July 25, 2007
First Posted: July 26, 2007
Results First Submitted: September 13, 2013
Results First Posted: May 22, 2014
Last Update Posted: May 22, 2014
Last Verified: April 2014

Keywords provided by VA Office of Research and Development:
sleep
melatonin
spinal cord injury
insomnia
tetraplegia

Additional relevant MeSH terms:
Spinal Cord Injuries
Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Parasomnias
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Sleep Disorders, Intrinsic
Dyssomnias
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Paralysis
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants