Trials / Completed
CompletedNCT00507546
Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia
Melatonin Replacement for Treatment of Sleep Disruption
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- US Department of Veterans Affairs · Federal
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ramelteon | 8 mg nightly |
| DRUG | Placebo | Nightly 8mg of placebo (same appearance as ramelteon) |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2010-12-01
- Completion
- 2011-07-01
- First posted
- 2007-07-26
- Last updated
- 2014-05-22
- Results posted
- 2014-05-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00507546. Inclusion in this directory is not an endorsement.