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Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

NCT00507546 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-05-22

Study results available
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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.

Conditions

  • Insomnia
  • Spinal Cord Injury
  • Tetraplegia
  • Sleep Disorders

Interventions

DRUG

Ramelteon

8 mg nightly

DRUG

Placebo

Nightly 8mg of placebo (same appearance as ramelteon)

Sponsors & Collaborators

Principal Investigators

  • Jamie M. Zeitzer, PhD · VA Palo Alto Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-12-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00507546 on ClinicalTrials.gov