MigrainePhase 3NCT00300924
A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine
A Phase 3 study testing Rizatriptan co-administered with Acetaminophen in people with Migraine, run by Diamond Headache Clinic at 7 sites in United States.
Trial summary
The purpose of this study is to test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Rizatriptan co-administered with Acetaminophen
- How many people
- 200 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2006to Jan 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age
- Subject has at least a 6 month history of migraine, with or without aura
- Subject can distinguish between migraine attacks and other types of headaches
- Subject of childbearing potential agrees to use adequate contraception
Who cannot join
- Subject typically has fewer than 1 or greater than 6 migraine attacks per month
- Subject typically has greater than 10 headache days per month
- Subject has evidence of ischemic heart disease
- Subject has uncontrolled high blood pressure
- Subject has a history, within 1 year, or current evidence of drug or alcohol abuse
- This list is not all inclusive
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Diamond Headache Clinic
Chicago, Illinois, 60614
Westside Family Medical Center
Kalamazoo, Michigan, 49009
Elkind Headache Center
Mount Vernon, New York, 10550
SanFrancisco Headache Clinic
San Francisco, California, 94109
Clinvest
Springfield, Missouri
Mercy Health Research
St Louis, Missouri, 63141
ClinExcel
West Chester, Ohio, 44121
About this study
Official title: A Double-Blind, Double-Dummy, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10mg Co-Administered With Acetaminophen for the Treatment of Acute Migraine.
The purpose of this study is to test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen.
- Conditions
- Migraine
- Being tested
- Rizatriptan co-administered with Acetaminophen
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rizatriptan co-administered with AcetaminophenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of rizatriptan co-administered with acetaminophen to placebo, acetaminophen and rizatriptan for the acute treatment of migraine, as measured by the percentage of patients with pain relief at 2 hours.
Secondary outcomes (8)
24 hour sustained pain relief
Pain relief at 30, 45,60,90 minutes and 4 hours post dose
Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose
24 sustained pain freedom
Associated symptoms of phonophobia, photophobia, nausea and vomiting
Functional disability
Use of rescue medication
Self-reported adverse experiences
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Diamond Headache Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Merle Diamond, M.D., Study director, Diamond Headache Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300924
- Sponsor's protocol ID
- Merck 075-00
- Other IDs
- Merk 075-00
- Status last verified
- May 2008
- First submitted
- 9 Mar 2006
- Last updated
- 28 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Double-Dummy, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10mg Co-Administered With Acetaminophen for the Treatment of Acute Migraine.
- ClinicalTrials.gov ID
- NCT00300924
- Acronym / sponsor ID
- Merck 075-00
- Conditions
- Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Diamond Headache ClinicUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 10 Mar 2006 (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 test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is at least 18 years of age
- Subject has at least a 6 month history of migraine, with or without aura
- Subject can distinguish between migraine attacks and other types of headaches
- Subject of childbearing potential agrees to use adequate contraception
Key exclusion criteria (6 listed)
- Subject typically has fewer than 1 or greater than 6 migraine attacks per month
- Subject typically has greater than 10 headache days per month
- Subject has evidence of ischemic heart disease
- Subject has uncontrolled high blood pressure
- Subject has a history, within 1 year, or current evidence of drug or alcohol 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 |
|---|---|---|
| Rizatriptan co-administered with Acetaminophen | Drug | – |
Primary outcome
To compare the efficacy of rizatriptan co-administered with acetaminophen to placebo, acetaminophen and rizatriptan for the acute treatment of migraine, as measured by the percentage of patients with pain relief at 2 hours.
8 secondary outcomes
24 hour sustained pain relief
Pain relief at 30, 45,60,90 minutes and 4 hours post dose
Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose
24 sustained pain freedom
Associated symptoms of phonophobia, photophobia, nausea and vomiting
Functional disability
Use of rescue medication
Self-reported adverse experiences
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 28 May 2008.
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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.
Merle Diamond, M.D. study director
Diamond Headache Clinic
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rizatriptan co-administered with Acetaminophen in people with Migraine, run by Diamond Headache Clinic at 7 sites 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 4 inclusion and 6 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 28 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 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?
To compare the efficacy of rizatriptan co-administered with acetaminophen to placebo, acetaminophen and rizatriptan for the acute treatment of migraine, as measured by the percentage of patients with pain relief at 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 28 May 2008.