Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

This study has been completed.
Sponsor:
Collaborators:
Stanford University
Takeda
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00507546
First received: July 25, 2007
Last updated: April 25, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Department of Veterans Affairs:

Primary Outcome Measures:
  • Amount of Wakefulness After Sleep Onset (WASO) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Stanford University
Takeda
Investigators
Principal Investigator: Jamie M. Zeitzer, PhD VA Palo Alto Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00507546     History of Changes
Other Study ID Numbers: B6010-R, 06-038R
Study First Received: July 25, 2007
Results First Received: September 13, 2013
Last Updated: April 25, 2014
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
Wounds and Injuries
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Sleep Disorders, Intrinsic
Dyssomnias
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014