REM Sleep Behavior DisorderPhase 4NCT01401413
Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder
A Phase 4 study testing ramelteon in people with REM Sleep Behavior Disorder, run by Sleep Medicine Centers of WNY at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the use of the drug ramelteon decreases the symptoms of REM Sleep Behavior Disorder. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- REM Sleep Behavior Disorder
- What is being tested?
- ramelteon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Sep 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets criteria for RBD as determined by screening PSG's
- steady bed partner for completion of RBD questionnaire
Who cannot join
- Hepatic impairment
- RBD associated with narcolepsy
- use of fluvoxamine, rifampin, fluconazole or ketoconazole
- current alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep Medicine Centers of WNY
West Seneca, New York, 14224
About this study
Official title: A Prospective Randomized, Placebo-Controlled Double-Blind Study to Determine the Efficacy of Ramelteon in REM Sleep Behavior Disorder
The purpose of this study is to determine whether the use of the drug ramelteon decreases the symptoms of REM Sleep Behavior Disorder.
Read the detailed description
This is a randomized double blind placebo controlled study to determine whether the use of ramelteon decreases symptoms of RBD. Outcome measures are determined by change in RBD polysomnographic score and assessment scores on the RBD symptom questionnaire and sleep diary.
- Conditions
- REM Sleep Behavior Disorder
- Being tested
- ramelteon, placebo
- Medical subject headings
- REM Sleep Behavior Disorder
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 for 30 nights
placeboDrug
placebo control i pill nightly for 30 nights
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | placebo control nightly Receives: Drug: placebo |
| 2 | Active comparator | 8 mg ramelteon nightly Receives: Drug: ramelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in polysomnographic scores
Measured: 30 days
Secondary outcomes (1)
change in RBD symptom questionnaire and sleep diary
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJan 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REM Sleep Behavior DisorderStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sleep Medicine Centers of WNY
- Sponsor type
- University, hospital or other
- Investigators
- Daniel I Rifkin, MD, Principal investigator, Sleep medicine Centers of Western New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401413
- Sponsor's protocol ID
- NEU1640207B
- Status last verified
- Jul 2011
- First submitted
- 22 Jul 2011
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Placebo-Controlled Double-Blind Study to Determine the Efficacy of Ramelteon in REM Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT01401413
- Acronym / sponsor ID
- NEU1640207B
- Conditions
- REM Sleep Behavior Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sleep Medicine Centers of WNYUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Not posted in the source record
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 whether the use of the drug ramelteon decreases the symptoms of REM Sleep Behavior Disorder.
Detailed description
This is a randomized double blind placebo controlled study to determine whether the use of ramelteon decreases symptoms of RBD. Outcome measures are determined by change in RBD polysomnographic score and assessment scores on the RBD symptom questionnaire and sleep diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboplacebo control nightly |
| 2 | Active comparator | Drug: ramelteon8 mg ramelteon nightly |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meets criteria for RBD as determined by screening PSG's
- steady bed partner for completion of RBD questionnaire
Key exclusion criteria (4 listed)
- Hepatic impairment
- RBD associated with narcolepsy
- use of fluvoxamine, rifampin, fluconazole or ketoconazole
- current alcohol or drug abuse
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 for 30 nights | Drug | 2 |
| placeboplacebo control i pill nightly for 30 nights | Drug | 1 |
Primary outcome
Change in polysomnographic scores
Time frame: 30 days
1 secondary outcome
change in RBD symptom questionnaire and sleep diary
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2011.
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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.
Daniel I Rifkin, MD principal investigator
Sleep medicine Centers of Western New York
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 REM Sleep Behavior Disorder, run by Sleep Medicine Centers of WNY 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 2 inclusion and 4 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 25 Jul 2011. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in polysomnographic scores (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2011.