InsomniaPhase 4NCT00507546
Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia
A Phase 4 study testing Ramelteon in people with Insomnia and Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Spinal Cord Injury, Tetraplegia
- What is being tested?
- Ramelteon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
About this study
Official title: Melatonin Replacement for Treatment of Sleep Disruption
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
- Being tested
- Ramelteon, Placebo
- Keywords
- sleep, melatonin, spinal cord injury, insomnia, tetraplegia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Spinal Cord Injuries, Quadriplegia, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamelteonDrug
Also called Rozerem
8 mg nightly
PlaceboDrug
Nightly 8mg of placebo (same appearance as ramelteon)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Ramelteon |
| 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks
Secondary outcomes (1)
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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Stanford University, Takeda
- Responsible party
- Sponsor
- Investigators
- Jamie M. Zeitzer, PhD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507546
- Sponsor's protocol ID
- B6010-R
- Other IDs
- 06-038R
- Status last verified
- Apr 2014
- First submitted
- 25 Jul 2007
- Last updated
- 22 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24090266
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Replacement for Treatment of Sleep Disruption
- ClinicalTrials.gov ID
- NCT00507546
- Acronym / sponsor ID
- B6010-R
- Conditions
- Insomnia, Spinal Cord Injury, Tetraplegia, Sleep Disorders
- Keywords
- sleep, melatonin, spinal cord injury, insomnia, tetraplegia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Stanford University, Takeda
- Study start
- Jul 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Jul 2007 (estimated)
- Results
- Posted 22 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ramelteon then placebo | Experimental | Drug: Ramelteon8 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 | Drug: Placeboplacebo nightly for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of 8 mg nightly ramelteon (cross-over) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamelteonAlso: Rozerem8 mg nightly | Drug | Ramelteon then placebo |
| PlaceboNightly 8mg of placebo (same appearance as ramelteon) | Drug | Placebo then ramelteon |
Primary outcome
Amount of Wakefulness After Sleep Onset (WASO)
Time frame: 10 weeks
Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment
1 secondary outcome
Change in Subjective Morning Alertness
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24090266Zeitzer 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie M. Zeitzer, PhD principal investigator
VA Palo Alto Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramelteon in people with Insomnia and Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Wakefulness After Sleep Onset (WASO) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00507546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014.