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| ID | Type | Description | Link |
|---|---|---|---|
| 06-038R | Other Grant/Funding Number | VA |
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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Takeda | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramelteon then placebo | Experimental | 8 mg nightly ramelteon for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of nightly placebo (cross-over) |
|
| Placebo then ramelteon | Experimental | placebo nightly for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of 8 mg nightly ramelteon (cross-over) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramelteon | Drug | 8 mg nightly |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie M. Zeitzer, PhD | VA Palo Alto Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304-1290 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24090266 | Result | 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. |
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Subjects excluded if baseline measure detected the presence of melatonin metabolite in their urine.
Subjects recruited from community
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Ramelteon then placebo Ramelteon : 8 mg nightly |
| FG001 | Arm 2 | Placebo then ramelteon Placebo : Nightly 8mg of placebo (same appearance as ramelteon) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Ramelteon then placebo Ramelteon : 8 mg nightly |
| BG001 | Arm 2 | Placebo then ramelteon Placebo : Nightly 8mg of placebo (same appearance as ramelteon) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All participants who completed the entire protocol. | Posted | Median | Full Range | Minutes | 10 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Ramelteon then placebo Ramelteon : 8 mg nightly |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jamie Zeitzer | VAPAHCS | 6504935000 | 62410 | jzeitzer@stanford.edu |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D013119 | Spinal Cord Injuries |
| D011782 | Quadriplegia |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C495910 | ramelteon |
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| Placebo | Drug | Nightly 8mg of placebo (same appearance as ramelteon) |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
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|
|
| 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 | Posted | Median | Full Range | units on a scale | 10 weeks |
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|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Arm 2 | Placebo then ramelteon Placebo : Nightly 8mg of placebo (same appearance as ramelteon) | 0 | 4 | 0 | 4 |
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| D013118 |
| Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |