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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


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
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