Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Insomnia Clinical Trial

Official title:

Melatonin Replacement for Treatment of Sleep Disruption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507546
• Other study ID #: B6010-R
• Secondary ID: 06-038R
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2007
• Last updated: April 25, 2014
• Start date: July 2007
• Est. completion date: July 2011

Study information

• Verified date: April 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Parasomnias
• Quadriplegia
• Sleep Disorders
• Spinal Cord Injuries
• Spinal Cord Injury
• Tetraplegia

Intervention

Drug:
• Ramelteon
8 mg nightly
• Placebo
Nightly 8mg of placebo (same appearance as ramelteon)

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Stanford University, Takeda

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Wakefulness After Sleep Onset (WASO)	Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment	10 weeks	No
Secondary	Change in Subjective Morning Alertness	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	10 weeks	No