Migraine HeadachePhase 3NCT00897104
MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
A Phase 3 study testing rizatriptan benzoate (MK0462) and Comparator: sumatriptan in people with Migraine Headache, run by Organon and Co.
Trial summary
A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- rizatriptan benzoate (MK0462) and Comparator: sumatriptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 933 participants
- Where
- No sites listed yet
- Study dates
- Aug 1995to Sep 1996
- Phase
- Phase 3
- 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
- Participant had at least a 6-month history of migraine, with or without aura
- Participant was male, or if female, must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions
- Participant was judged to be in good health, apart from migraine
Who cannot join
- Participant was Pregnant or a nursing mother
- Participant had a history or current evidence of drug or alcohol abuse
- Participant had a history or clinical evidence of cardiovascular disease
- Participant had a clinically significant Electrocardiography (ECG) abnormality
- Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
- Participant had received treatment with an investigational device or compound within 30 days of the study
Show all 9Show fewer
- Participant typically suffered from less then 1 or more than 8 attacks of migraine per month
- Participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
- Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium
About this study
Official title: A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Compare the Efficacy and Safety of MK0462 5 mg p.o. and Sumatriptan 50 mg p.o. for the Acute Treatment of Migraine
A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.
- Conditions
- Migraine Headache
- Being tested
- rizatriptan benzoate (MK0462), Comparator: sumatriptan, Comparator: Placebo
- 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 benzoate (MK0462)Drug
Also called MK0462
single dose 5 mg rizatriptan p.o.
Comparator: sumatriptanDrug
single dose 50 mg sumatriptan p.o.
Comparator: PlaceboDrug
Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rizatriptan Receives: Drug: rizatriptan benzoate (MK0462) |
| 2 | Experimental | Sumatriptan Receives: Drug: Comparator: sumatriptan |
| 3 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief at 2 Hours After Treatment
Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
Measured: 2 hours after treatment
Time to Relief Within 2 Hours After Treatment
Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).
Measured: within 2 hours after treatment
Secondary outcomes (5)
Pain Free at 2 Hours After Treatment
Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
Measured: 2 hours after treatment
Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities
Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).
Measured: 2 hours after treatment
Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment
Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.
Measured: 2 hours after treatment
Participants Who Used Escape Medication 2 Hours After the Treatment Dose
Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.
Measured: 2 hours after treatment
Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])
Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence
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 posted12 May 2009 (estimated)
- Study startAug 1995
- Primary completionMay 1996
- Study completionSep 1996
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Migraine HeadacheStudies 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
- 933 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
- NCT00897104
- Sponsor's protocol ID
- 0462-029
- Other IDs
- 2009_593
- Status last verified
- Feb 2022
- First submitted
- 8 May 2009
- Last updated
- 3 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ho TW, Fan X, Rodgers A, Lines CR, Winner P, Shapiro RE. Age effects on placebo response rates in clinical trials of acute agents for migraine: pooled analysis of rizatriptan trials in adults. Cephalalgia. 2009 Jul;29(7):711-8. doi: 10.1111/j.1468-2982.2008.01788.x. Epub 2009 Feb 3.
PubMed 19210513Ferrari MD, Loder E, McCarroll KA, Lines CR. Meta-analysis of rizatriptan efficacy in randomized controlled clinical trials. Cephalalgia. 2001 Mar;21(2):129-36. doi: 10.1046/j.1468-2982.2001.00169.x.
PubMed 11422095Block GA, Goldstein J, Polis A, Reines SA, Smith ME. Efficacy and safety of rizatriptan versus standard care during long-term treatment for migraine. Rizatriptan Multicenter Study Groups. Headache. 1998 Nov-Dec;38(10):764-71. doi: 10.1046/j.1526-4610.1998.3810764.x.
PubMed 11284464
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Compare the Efficacy and Safety of MK0462 5 mg p.o. and Sumatriptan 50 mg p.o. for the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT00897104
- Acronym / sponsor ID
- 0462-029
- Conditions
- Migraine Headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 933 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Aug 1995
- Primary completion
- May 1996 (actual)
- Study completion
- Sep 1996 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Posted 23 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: rizatriptan benzoate (MK0462)Rizatriptan |
| 2 | Experimental | Drug: Comparator: sumatriptanSumatriptan |
| 3 | Placebo comparator | Drug: Comparator: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant had at least a 6-month history of migraine, with or without aura
- Participant was male, or if female, must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions
- Participant was judged to be in good health, apart from migraine
Key exclusion criteria (9 listed)
- Participant was Pregnant or a nursing mother
- Participant had a history or current evidence of drug or alcohol abuse
- Participant had a history or clinical evidence of cardiovascular disease
- Participant had a clinically significant Electrocardiography (ECG) abnormality
- Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
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 benzoate (MK0462)Also: MK0462single dose 5 mg rizatriptan p.o. | Drug | 1 |
| Comparator: sumatriptansingle dose 50 mg sumatriptan p.o. | Drug | 2 |
| Comparator: PlaceboPlacebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally | Drug | 3 |
Primary outcome
Pain Relief at 2 Hours After Treatment
Time frame: 2 hours after treatment
Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
Time to Relief Within 2 Hours After Treatment
Time frame: within 2 hours after treatment
Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).
5 secondary outcomes
Pain Free at 2 Hours After Treatment
Time frame: 2 hours after treatment
Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities
Time frame: 2 hours after treatment
Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment
Time frame: 2 hours after treatment
Participants Who Used Escape Medication 2 Hours After the Treatment Dose
Time frame: 2 hours after treatment
Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19210513Ho TW, Fan X, Rodgers A, Lines CR, Winner P, Shapiro RE. Age effects on placebo response rates in clinical trials of acute agents for migraine: pooled analysis of rizatriptan trials in adults. Cephalalgia. 2009 Jul;29(7):711-8. doi: 10.1111/j.1468-2982.2008.01788.x. Epub 2009 Feb 3.
- Results publication: PubMed 11422095Ferrari MD, Loder E, McCarroll KA, Lines CR. Meta-analysis of rizatriptan efficacy in randomized controlled clinical trials. Cephalalgia. 2001 Mar;21(2):129-36. doi: 10.1046/j.1468-2982.2001.00169.x.
- Results publication: PubMed 11284464Block GA, Goldstein J, Polis A, Reines SA, Smith ME. Efficacy and safety of rizatriptan versus standard care during long-term treatment for migraine. Rizatriptan Multicenter Study Groups. Headache. 1998 Nov-Dec;38(10):764-71. doi: 10.1046/j.1526-4610.1998.3810764.x.
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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 rizatriptan benzoate (MK0462) and Comparator: sumatriptan in people with Migraine Headache, 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 9 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 3 Feb 2022. 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. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2010). 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?
Pain Relief at 2 Hours After Treatment (time frame: 2 hours after treatment). The study lists 2 primary outcomes in all. 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 NCT00897104, which also lists 3 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 3 Feb 2022.