MigrainePhase 3NCT00111709
Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-071)
A Phase 3 study testing MK0462, rizatriptan benzoate / Duration of Treatment -1 day in people with Migraine, run by Organon and Co.
Trial summary
The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Migraine
- What is being tested?
- MK0462, rizatriptan benzoate / Duration of Treatment -1 day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 393 participants
- Where
- No sites listed yet
- Study dates
- 27 May 2005to 26 Feb 2006
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient at least 18 years old
- Patient has menses approximately monthly
- Patient has at least a 5 month history of migraine and at least a 6 month history of menstrual migraine
Who cannot join
- Pregnant and/or nursing
- Cardiovascular disease
- Uncontrolled hypertension
About this study
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg Tablets for the Treatment of Menstrual Migraine
The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.
- Conditions
- Migraine
- Being tested
- MK0462, rizatriptan benzoate / Duration of Treatment -1 day, Comparator: placebo / Duration of Treatment - 1 day
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0462, rizatriptan benzoate / Duration of Treatment -1 dayDrug
Comparator: placebo / Duration of Treatment - 1 dayDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary
Secondary outcomes (1)
Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose as recorded in patient diary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2005 (estimated)
- Study start27 May 2005
- Primary completion24 Feb 2006
- Study completion26 Feb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111709
- Sponsor's protocol ID
- 0462-071
- Other IDs
- 2005_024
- Status last verified
- Feb 2022
- First submitted
- 24 May 2005
- Last updated
- 14 Aug 2024
- Results posted
- No
Publications
Mannix LK, Loder E, Nett R, Mueller L, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies. Cephalalgia. 2007 May;27(5):414-21. doi: 10.1111/j.1468-2982.2007.01313.x.
PubMed 17448179Nett R, Mannix LK, Mueller L, Rodgers A, Hustad CM, Skobieranda F, Ramsey KE. Rizatriptan efficacy in ICHD-II pure menstrual migraine and menstrually related migraine. Headache. 2008 Sep;48(8):1194-201. doi: 10.1111/j.1526-4610.2008.01093.x. Epub 2008 Apr 14.
PubMed 18422606
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg Tablets for the Treatment of Menstrual Migraine
- ClinicalTrials.gov ID
- NCT00111709
- Acronym / sponsor ID
- 0462-071
- Conditions
- Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 27 May 2005 (actual)
- Primary completion
- 24 Feb 2006 (actual)
- Study completion
- 26 Feb 2006 (actual)
- First posted
- 25 May 2005 (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 the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patient at least 18 years old
- Patient has menses approximately monthly
- Patient has at least a 5 month history of migraine and at least a 6 month history of menstrual migraine
Key exclusion criteria (3 listed)
- Pregnant and/or nursing
- Cardiovascular 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 |
|---|---|---|
| MK0462, rizatriptan benzoate / Duration of Treatment -1 day | Drug | – |
| Comparator: placebo / Duration of Treatment - 1 day | Drug | – |
Primary outcome
Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary
1 secondary outcome
Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose as recorded in patient diary
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 14 Aug 2024.
- Background: PubMed 17448179Mannix LK, Loder E, Nett R, Mueller L, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies. Cephalalgia. 2007 May;27(5):414-21. doi: 10.1111/j.1468-2982.2007.01313.x.
- Background: PubMed 18422606Nett R, Mannix LK, Mueller L, Rodgers A, Hustad CM, Skobieranda F, Ramsey KE. Rizatriptan efficacy in ICHD-II pure menstrual migraine and menstrually related migraine. Headache. 2008 Sep;48(8):1194-201. doi: 10.1111/j.1526-4610.2008.01093.x. Epub 2008 Apr 14.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0462, rizatriptan benzoate / Duration of Treatment -1 day in people with Migraine, run by Organon and Co.
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 3 inclusion and 3 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 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary. 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 NCT00111709, which also lists 2 linked publications.
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 14 Aug 2024.