Migraine With AuraPhase 3NCT00471952
Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache
A Phase 3 study testing Maxalt 10mg MLT plus Caffeine 75mg in people with Migraine With Aura and Migraine Without Aura, run by Diamond Headache Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of rizatriptan, alone or combined with caffeine for treating acute attacks of migraine. Each subject will have 3 months to treat 3 acute migraine headache attacks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine With Aura, Migraine Without Aura
- What is being tested?
- Maxalt 10mg MLT plus Caffeine 75mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 2008
- Phase
- Phase 3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is 18-65 years of age
- Diagnosis of migraine with or without aura
- 1 year history of migraine with 1-6 migraine attacks per month in the the three months prior to screening
- Medication for migraine prevention with a stable dose for at least 1 month prior to screening
- Has successfully treated a migraine attack with a triptan medication
Who cannot join
- Confirmed or suspected ischemic heart disease
- History of congenital heart disease
- History of cerebrovascular disease, including stroke
- History of ischemic abdominal disease
- Uncontrolled hypertension
- History of epilepsy
Show all 16Show fewer
- History of basilar or hemiplegic migraine
- Impaired hepatic or renal function
- Greater than 15 headache days per month
- Subjects on an MAOI
- Subjects taking and ergotamine, or ergot containing preventive medication
- Subject is pregnant, trying to become pregnant or breast feeing
- Evidence of alcohol or substance abuse in the last year
- History of caffeine withdrawal headache
- Consumes more than 275 mg of caffeine on daily basis from dietary and medication sources
- Taking propanolol
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effect of rizatriptan, alone or combined with caffeine for treating acute attacks of migraine.
Each subject will have 3 months to treat 3 acute migraine headache attacks. Each subject will be dispensed one box containing 3 packets of study medication labeled for Headache #1, Headache #2, or Headache #3. Each packet wil contain either Maxalt 10mg MLT or a Maxalt placebo (sugar pill), and a capsule containing either caffeine 75mg or a capsule containing placebo (sugar).
Read more
One headache will be treated with a combination of Maxalt 10mg MLT and caffeine.
Another headache will be treated with a combination of Maxalt 10mg MLT and a capsule containing placebo.
A third headache will be treated with just placebo.
Neither the subject, the study coordinator, or your study doctor will know in which order you will receive the three different treatments. This information is available in case of emergency.
Read the detailed description
Oral Maxalt has an extensive record of providing relief of acute migraine headache with 2 hours in the vast majority of patients, especially when undertaken as an early intervention strategy. Caffeine has been demonstrated to have analgesic effects in patients treating tension type headache and is found as part of a combination including aspirin and acetaminophen as a treatment for acute migraine headache.
The mechanism by which Maxalt relieves migraine headache is believed to be through action on 5HT1B/1D receptors both on blood vessels as well as centrally. Caffeine may have effects on relief of migraine through modifying norepinephrine related mechanisms which have been suggested through clinical research. Patients commonly report that they may obtain partial or complete relief of their migraines by consuming the modest amounts of caffeine found in a cup of coffee. this is estimated to be approximately 100mg per cup. The analgesic effects of caffeine appear to be most significant in the first 3 hours after ingestion. Recent work suggests that intervention in migraine when the pain is still mild and has not persisted for a prolonged duration may increase the likelihood of complete migraine response. Therefore, the combination of the two agents with activity in migraine that work early in the migraine process, have good tolerability at the proposed doses and working via different mechanism may increase the likelihood of patients achieving better response with their migraine treatment than that which is currently available.
- Conditions
- Migraine With Aura, Migraine Without Aura
- Being tested
- Maxalt 10mg MLT plus Caffeine 75mg, Maxalt 10mg MLT plus Placebo, Placebo + Placebo
- Keywords
- Migraine
- Medical subject headings
- Migraine with Aura, Migraine without Aura, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxalt 10mg MLT plus Caffeine 75mgDrug
One migraine attack will be treated
Maxalt 10mg MLT plus PlaceboDrug
One migraine attack will be treated with Maxalt 10mg plus placebo
Placebo + PlaceboDrug
One migraine attack will be treated with double placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Maxalt 10mg with Caffeine 75mg Receives: Drug: Maxalt 10mg MLT plus Caffeine 75mg |
| 2 | Active comparator | Maxalt 10mg plus Placebo Receives: Drug: Maxalt 10mg MLT plus Placebo |
| 3 | Placebo comparator | Double placebo Receives: Drug: Placebo + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparative percentage of migraine attacks that produce pain free response at 2 hours in the Maxalt 10mg MLT plus caffeine 75mg arm versus the Maxalt 10mg MLT plus placebo caffeine versus double placebo.
Measured: 2 hours
Secondary outcomes (5)
The comparative percentage of attacks that produce pain relief at 2 hours.
Measured: 2 hours
The comparative percentage of attacks that produce a pain free response and do not require re-treatment during the subsequent 24 hours and are not associated with headache pain recurrence.
Measured: 24 hours
The comparative percentage of resolution of associated symptoms of migraine present at the time of treatment as well as achieving a pain free response within 2 hours with each of the treatments.
Measured: 2 hours
The comparative number of patients reporting adverse effects to study medication, the type of adverse events reported and the percentage of attacks that are associated with the adverse effect.
Measured: 24 hours
Patient global evaluation for each of the treatments
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study startApr 2007
- Primary completionFeb 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With AuraStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diamond Headache Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Frederick G Freitag, DO, Principal investigator, Diamond Headache Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471952
- Sponsor's protocol ID
- DHC 09
- Status last verified
- Apr 2012
- First submitted
- 8 May 2007
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache
- ClinicalTrials.gov ID
- NCT00471952
- Acronym / sponsor ID
- DHC 09
- Conditions
- Migraine With Aura, Migraine Without Aura
- Keywords
- Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Diamond Headache ClinicUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 10 May 2007 (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 evaluate the effect of rizatriptan, alone or combined with caffeine for treating acute attacks of migraine.
Each subject will have 3 months to treat 3 acute migraine headache attacks. Each subject will be dispensed one box containing 3 packets of study medication labeled for Headache #1, Headache #2, or Headache #3. Each packet wil contain either Maxalt 10mg MLT or a Maxalt placebo (sugar pill), and a capsule containing either caffeine 75mg or a capsule containing placebo (sugar).
One headache will be treated with a combination of Maxalt 10mg MLT and caffeine.
Another headache will be treated with a combination of Maxalt 10mg MLT and a capsule containing placebo.
A third headache will be treated with just placebo.
Neither the subject, the study coordinator, or your study doctor will know in which order you will receive the three different treatments. This information is available in case of emergency.
Detailed description
Oral Maxalt has an extensive record of providing relief of acute migraine headache with 2 hours in the vast majority of patients, especially when undertaken as an early intervention strategy. Caffeine has been demonstrated to have analgesic effects in patients treating tension type headache and is found as part of a combination including aspirin and acetaminophen as a treatment for acute migraine headache.
The mechanism by which Maxalt relieves migraine headache is believed to be through action on 5HT1B/1D receptors both on blood vessels as well as centrally. Caffeine may have effects on relief of migraine through modifying norepinephrine related mechanisms which have been suggested through clinical research. Patients commonly report that they may obtain partial or complete relief of their migraines by consuming the modest amounts of caffeine found in a cup of coffee. this is estimated to be approximately 100mg per cup. The analgesic effects of caffeine appear to be most significant in the first 3 hours after ingestion. Recent work suggests that intervention in migraine when the pain is still mild and has not persisted for a prolonged duration may increase the likelihood of complete migraine response. Therefore, the combination of the two agents with activity in migraine that work early in the migraine process, have good tolerability at the proposed doses and working via different mechanism may increase the likelihood of patients achieving better response with their migraine treatment than that which is currently available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Maxalt 10mg MLT plus Caffeine 75mgMaxalt 10mg with Caffeine 75mg |
| 2 | Active comparator | Drug: Maxalt 10mg MLT plus PlaceboMaxalt 10mg plus Placebo |
| 3 | Placebo comparator | Drug: Placebo + PlaceboDouble placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is 18-65 years of age
- Diagnosis of migraine with or without aura
- 1 year history of migraine with 1-6 migraine attacks per month in the the three months prior to screening
- Medication for migraine prevention with a stable dose for at least 1 month prior to screening
- Has successfully treated a migraine attack with a triptan medication
Key exclusion criteria (16 listed)
- Confirmed or suspected ischemic heart disease
- History of congenital heart disease
- History of cerebrovascular disease, including stroke
- History of ischemic abdominal disease
- Uncontrolled hypertension
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 |
|---|---|---|
| Maxalt 10mg MLT plus Caffeine 75mgOne migraine attack will be treated | Drug | 1 |
| Maxalt 10mg MLT plus PlaceboOne migraine attack will be treated with Maxalt 10mg plus placebo | Drug | 2 |
| Placebo + PlaceboOne migraine attack will be treated with double placebo | Drug | 3 |
Primary outcome
The comparative percentage of migraine attacks that produce pain free response at 2 hours in the Maxalt 10mg MLT plus caffeine 75mg arm versus the Maxalt 10mg MLT plus placebo caffeine versus double placebo.
Time frame: 2 hours
5 secondary outcomes
The comparative percentage of attacks that produce pain relief at 2 hours.
Time frame: 2 hours
The comparative percentage of attacks that produce a pain free response and do not require re-treatment during the subsequent 24 hours and are not associated with headache pain recurrence.
Time frame: 24 hours
The comparative percentage of resolution of associated symptoms of migraine present at the time of treatment as well as achieving a pain free response within 2 hours with each of the treatments.
Time frame: 2 hours
The comparative number of patients reporting adverse effects to study medication, the type of adverse events reported and the percentage of attacks that are associated with the adverse effect.
Time frame: 24 hours
Patient global evaluation for each of the treatments
Time frame: 24 hours
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 Apr 2012.
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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.
Frederick G Freitag, DO principal investigator
Diamond Headache Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Maxalt 10mg MLT plus Caffeine 75mg in people with Migraine With Aura and Migraine Without Aura, run by Diamond Headache Clinic 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 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: finished, as of the sponsor's last update on 25 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The comparative percentage of migraine attacks that produce pain free response at 2 hours in the Maxalt 10mg MLT plus caffeine 75mg arm versus the Maxalt 10mg MLT plus placebo caffeine versus double placebo. (time frame: 2 hours). 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 Apr 2012.