MigrainePhase 2NCT00739024
A Study of a Melatonin Receptor Agonist to Prevent Migraine
A Phase 2 study testing Ramelteon in people with Migraine and Migraine With Aura, run by Swedish Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to see if ramelteon will reduce the number of migraine headaches over a 12 week period. The safety and tolerability of ramelteon will also be evaluated. Ramelteon has been approved by the U.S. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Migraine With Aura, Migraine Without Aura
- 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
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Sep 2010
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, ages 18 to 65 years, inclusive.
- An established history of migraine, with or without aura and probable migraine, conforming to the revised IHS criteria (2004) for at least 1 year before screening, sufficient to establish the diagnosis.
- To be randomized, during the prospective 4-week baseline period (approximately 28 days before Visit 2), subjects must have more than 4 migraine/probable migraine attacks per month (using the 24-hour rule).
- Must have been less than 50 years of age at the time of initial migraine onset.
- Must have no clinically significant and relevant abnormalities on physical or neurologic examinations
- Must have completed a washout of all prophylactic medications for migraine before the start of the 4-week prospective baseline period (ie, 28 days before Visit 2, when randomization occurs).
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- Female subjects must be at least 1 of the following:
- postmenopausal, or
- surgically incapable of being children, or
- practicing a highly effective method of birth control
Who cannot join
- Most frequent type of headache does not meet the revised IHS diagnostic criteria for migraine with aura or without aura or probable migraine.
- Pregnant or lactating women, or sexually active women of childbearing potential who are not using an appropriate method of contraception.
- Failed adequate trials of prophylactic agents with demonstrated or possible efficacy in the prophylaxis of migraine. These agents include beta-blockers, tricyclic antidepressants, valproate, topiramate, and methysergide.
- Unable to complete the diary in a timely and accurate manner after each migraine headache attacks, either independently or with assistance.
- Overuse of analgesics or specific agents for abortive treatment of migraine attacks, which makes the investigator suspect medication overuse headache.
- Receiving non-pharmacological prophylactic treatments such as acupuncture, chiropractic, or massage, if these were started less than 1 month before the screening visit (Day -28). These therapies may be continued if started before that time.
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- Currently abusing alcohol or other drugs.
- Have a central nervous system neoplasm or infection, demyelinating disease, degenerative or progressive central nervous system disease, or active epilepsy.
- History of serious systemic disease, including hepatic insufficiency, renal insufficiency, a malignant neoplasm, any disorder in which prognosis for survival is less than 3 months, or any disorder which in the judgment of the investigator will place the subject at excessive risk by participation in a controlled trial.
- Have a significant psychiatric disorder, such as acute psychosis, schizophrenia, severe bipolar disorder, or severe unipolar mood disorder, of sufficient severity to preclude safe and effective participation of the subject in the study.
- Require continued use of any of protocol-defined prohibited medications during the study
- Have any recent or remote history of suicide attempt or ideation
- Known or strongly suspected to be non-compliant in administering daily medications.
- Received an experimental drug or used an experimental device within 30 days before the Screening Visit.
- Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
- Any reason for which the investigator, upon her evaluation, feels that it is in the subject's best interest not to continue on in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Swedish Pain and Headache Center
Seattle, Washington, 98104
About this study
Official title: A Randomized, Double-blind Placebo-controlled, Parallel Group Study to Study the Efficacy and Tolerability of Ramelteon (Rozerem) in the Prophylaxis of Migraine
The purpose of this study is to see if ramelteon will reduce the number of migraine headaches over a 12 week period. The safety and tolerability of ramelteon will also be evaluated. Ramelteon has been approved by the U.S. Food and Drug Administration (FDA) for insomnia (trouble sleeping); however; ramelteon has not been approved for the prevention of migraines.
Read the detailed description
Sleep has played an important role in migraine. Younger migraine sufferers usually report relief of migraine after sleep. In older migraine sufferers migraine is sometimes triggered with sleep changes. Occurrence of migraine in the early morning is very common. Therefore in these individuals regulation of sleep may improve the frequency of migraine. Recent PET studies done during migraine demonstrated activation of hypothalamus during migraine. In light of this new data and the known action of ramelteon on the melatonin receptors it may theoretically provide an insight on a possible mechanism of action in migraine.
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura
- Being tested
- Ramelteon, Placebo
- Keywords
- Migraine, Headache
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura, Headache
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 tablet, oral, once daily
PlaceboDrug
Placebo tablet, oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Ramelteon once daily (double-blind assignment) Receives: Drug: Ramelteon |
| Placebo | Placebo comparator | Placebo tablet, once daily (double-blind assignment) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-Test
It was planned to use a simple T-Test or ANoVa for data analysis. No Analysis was made due to insufficient recruitment. Planned primary efficacy variable was the percent reduction in the average monthly miqraine/probable migraine frequency from the baseline period to the entire double-blind treatment phase of the study.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionSep 2010
Why it stopped: Recruitment slow and administrative reasons
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.
- Other trials for MigraineStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Sheena K Aurora, MD, Principal investigator, Swedish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739024
- Sponsor's protocol ID
- CRC 0690
- Status last verified
- Aug 2012
- First submitted
- 19 Aug 2008
- Last updated
- 23 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Placebo-controlled, Parallel Group Study to Study the Efficacy and Tolerability of Ramelteon (Rozerem) in the Prophylaxis of Migraine
- ClinicalTrials.gov ID
- NCT00739024
- Acronym / sponsor ID
- CRC 0690
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura
- Keywords
- Migraine, Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment slow and administrative reasons
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Aug 2008 (estimated)
- Results
- Posted 23 Aug 2012
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 see if ramelteon will reduce the number of migraine headaches over a 12 week period. The safety and tolerability of ramelteon will also be evaluated. Ramelteon has been approved by the U.S. Food and Drug Administration (FDA) for insomnia (trouble sleeping); however; ramelteon has not been approved for the prevention of migraines.
Detailed description
Sleep has played an important role in migraine. Younger migraine sufferers usually report relief of migraine after sleep. In older migraine sufferers migraine is sometimes triggered with sleep changes. Occurrence of migraine in the early morning is very common. Therefore in these individuals regulation of sleep may improve the frequency of migraine. Recent PET studies done during migraine demonstrated activation of hypothalamus during migraine. In light of this new data and the known action of ramelteon on the melatonin receptors it may theoretically provide an insight on a possible mechanism of action in migraine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Drug: RamelteonRamelteon once daily (double-blind assignment) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet, once daily (double-blind assignment) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, ages 18 to 65 years, inclusive.
- An established history of migraine, with or without aura and probable migraine, conforming to the revised IHS criteria (2004) for at least 1 year before screening, sufficient to establish the diagnosis.
- To be randomized, during the prospective 4-week baseline period (approximately 28 days before Visit 2), subjects must have more than 4 migraine/probable migraine attacks per month (using the 24-hour rule).
- Must have been less than 50 years of age at the time of initial migraine onset.
- Must have no clinically significant and relevant abnormalities on physical or neurologic examinations
Key exclusion criteria (16 listed)
- Most frequent type of headache does not meet the revised IHS diagnostic criteria for migraine with aura or without aura or probable migraine.
- Pregnant or lactating women, or sexually active women of childbearing potential who are not using an appropriate method of contraception.
- Failed adequate trials of prophylactic agents with demonstrated or possible efficacy in the prophylaxis of migraine. These agents include beta-blockers, tricyclic antidepressants, valproate, topiramate, and methysergide.
- Unable to complete the diary in a timely and accurate manner after each migraine headache attacks, either independently or with assistance.
- Overuse of analgesics or specific agents for abortive treatment of migraine attacks, which makes the investigator suspect medication overuse headache.
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 tablet, oral, once daily | Drug | Active Treatment |
| PlaceboPlacebo tablet, oral, once daily | Drug | Placebo |
Primary outcome
T-Test
Time frame: 4 weeks
It was planned to use a simple T-Test or ANoVa for data analysis. No Analysis was made due to insufficient recruitment. Planned primary efficacy variable was the percent reduction in the average monthly miqraine/probable migraine frequency from the baseline period to the entire double-blind treatment phase of the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Swedish Headache ResearchLink provided by the sponsor.
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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.
Sheena K Aurora, MD principal investigator
Swedish Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ramelteon in people with Migraine and Migraine With Aura, run by Swedish Medical Center 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 10 inclusion and 16 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: stopped early, as of the sponsor's last update on 23 Aug 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 Aug 2012). 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?
T-Test (time frame: 4 weeks). 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 23 Aug 2012.