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

July 25, 2007
April 25, 2014
July 2007
December 2010   (final data collection date for primary outcome measure)
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
Improvement in subjective and objective sleep parameters [ Time Frame: 10 weeks ]
Complete list of historical versions of study NCT00507546 on ClinicalTrials.gov Archive Site
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
Improvement in daytime alertness and overall quality of life. [ Time Frame: 10 weeks ]
Not Provided
Not Provided
 
Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia
Melatonin Replacement for Treatment of Sleep Disruption

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Insomnia
  • Spinal Cord Injury
  • Tetraplegia
  • Sleep Disorders
  • Drug: Ramelteon
    8 mg nightly
    Other Name: Rozerem
  • Drug: Placebo
    Nightly 8mg of placebo (same appearance as ramelteon)
  • 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)
    Intervention: Drug: Ramelteon
  • 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)
    Intervention: Drug: Placebo
Zeitzer JM, Ku B, Ota D, Kiratli BJ. Randomized controlled trial of pharmacological replacement of melatonin for sleep disruption in individuals with tetraplegia. J Spinal Cord Med. 2014 Jan;37(1):46-53. doi: 10.1179/2045772313Y.0000000099. Epub 2013 Oct 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00507546
B6010-R, 06-038R
No
Department of Veterans Affairs
Department of Veterans Affairs
  • Stanford University
  • Takeda
Principal Investigator: Jamie M. Zeitzer, PhD VA Palo Alto Health Care System
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP