Migraine HeadachePhase 3NCT00898677

Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

A Phase 3 study testing rizatriptan benzoate and Comparator: sumatriptan in people with Migraine Headache, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine. 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 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: 1,268 participants
Where: No sites listed yet
Study dates: Sep 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

Patient had at least a 6-month history of migraine, with or without aura
Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
Patient was judged to be in good health, apart from migraine

Who cannot join

Patient was pregnant or a nursing mother
Patient had abused drugs or alcohol within 12 months prior to entering the study
Patient had a history of cardiovascular disease
Patient had clinically significant Electrocardiography (ECG) abnormality
Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
Patient received treatment with an investigational device or compound within 30 days of the study start

Show all 10Show fewer

Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
Patient had hypersensitivity to sumatriptan
Patient had participated in any previous study involving rizatriptan

About this study

Official title: A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Examine the Safety, Tolerability, and Efficacy of Single Oral Doses of MK0462 5 mg, MK0462 10 mg, and Sumatriptan 100 mg for Acute Treatment of Migraine

Conditions: Migraine Headache
Being tested: rizatriptan benzoate, 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 benzoateDrug
Also called rizatriptan, MK0462
single dose administration of 5mg rizatriptan (by Mouth) p.o.
rizatriptan benzoateDrug
Also called rizatriptan, MK0462
single dose administration of 10 mg rizatriptan p.o.
Comparator: sumatriptanDrug
Also called sumatriptan
single dose administration of sumatriptan 100 p.o.
Comparator: PlaceboDrug
placebo to rizatriptan

Study groups in NCT00898677
Study group	Role	What they receive
1	Experimental	rizatriptan 5 mg Receives: Drug: rizatriptan benzoate
2	Experimental	rizatriptan 10 mg Receives: Drug: rizatriptan benzoate
3	Active comparator	sumatriptan 100 mg Receives: Drug: Comparator: sumatriptan
4	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 Dose
Patients 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 dose
Time to Relief Within 2 Hours After Dose
Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose
Measured: within 2 hours after dose

Secondary outcomes (3)

Pain Free at 2 Hours After Dose
Patients pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
Measured: 2 hours after dose
Functional Status at 2 Hours After Dose
Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).
Measured: 2 hours after dose
Nausea at 2 Hours After Dose
Patients who recorded the presence or absence of nausea 2 hours after dose
Measured: 2 hours after dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 1995Sep 1996

First posted12 May 2009 (estimated)
Study startSep 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 (2)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: 1,268 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00898677
Sponsor's protocol ID: 0462-030
Other IDs: 2009_591
Status last verified: Feb 2022
First submitted: 8 May 2009
Last updated: 3 Feb 2022
Results posted: Yes, on ClinicalTrials.gov

Publications

Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12.
PubMed 19222588
Tfelt-Hansen P, Teall J, Rodriguez F, Giacovazzo M, Paz J, Malbecq W, Block GA, Reines SA, Visser WH. Oral rizatriptan versus oral sumatriptan: a direct comparative study in the acute treatment of migraine. Rizatriptan 030 Study Group. Headache. 1998 Nov-Dec;38(10):748-55. doi: 10.1046/j.1526-4610.1998.3810748.x.
PubMed 11284463

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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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 Examine the Safety, Tolerability, and Efficacy of Single Oral Doses of MK0462 5 mg, MK0462 10 mg, and Sumatriptan 100 mg for Acute Treatment of Migraine
ClinicalTrials.gov ID: NCT00898677
Acronym / sponsor ID: 0462-030
Conditions: Migraine Headache
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,268 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Sep 1995
Primary completion: May 1996 (actual)
Study completion: Sep 1996 (actual)
First posted: 12 May 2009 (estimated)
Results: Posted 14 Jul 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: rizatriptan benzoaterizatriptan 5 mg
2	Experimental	Drug: rizatriptan benzoaterizatriptan 10 mg
3	Active comparator	Drug: Comparator: sumatriptansumatriptan 100 mg
4	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)

Patient had at least a 6-month history of migraine, with or without aura
Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
Patient was judged to be in good health, apart from migraine

Key exclusion criteria (10 listed)

Patient was pregnant or a nursing mother
Patient had abused drugs or alcohol within 12 months prior to entering the study
Patient had a history of cardiovascular disease
Patient had clinically significant Electrocardiography (ECG) abnormality
Patient 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 benzoateAlso: rizatriptan, MK0462single dose administration of 5mg rizatriptan (by Mouth) p.o.	Drug	1
rizatriptan benzoateAlso: rizatriptan, MK0462single dose administration of 10 mg rizatriptan p.o.	Drug	2
Comparator: sumatriptanAlso: sumatriptansingle dose administration of sumatriptan 100 p.o.	Drug	3
Comparator: Placeboplacebo to rizatriptan	Drug	4

Primary outcome

Pain Relief at 2 Hours After Dose
Time frame: 2 hours after dose
Patients 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 Dose
Time frame: within 2 hours after dose
Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose

3 secondary outcomes

Pain Free at 2 Hours After Dose
Time frame: 2 hours after dose
Functional Status at 2 Hours After Dose
Time frame: 2 hours after dose
Nausea at 2 Hours After Dose
Time frame: 2 hours after dose

Results and safety

Results posted to the registry on 14 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rizatriptan 5 mg	180	163
Rizatriptan 10 mg	455	386
Sumatriptan 100 mg	455	383
Placebo	178	159

Primary outcome: Pain Relief at 2 Hours After Dose

Time frame: 2 hours after dose. Number. Unit: Participants

Measure	Rizatriptan 5 mg n = 164	Rizatriptan 10 mg n = 385	Sumatriptan 100 mg n = 387	Placebo n = 159
2-hour pain relief	99	258	239	64
No 2-hour pain relief	65	127	148	95

Population analysed: An "all-patients-treated" approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase.

Primary outcome: Time to Relief Within 2 Hours After Dose

Time frame: within 2 hours after dose. Number. Unit: Participants

Measure	Rizatriptan 5 mg n = 164	Rizatriptan 10 mg n = 385	Sumatriptan 100 mg n = 387	Placebo n = 159
First pain relief within 2 hrs	102	265	247	72
Pain relief did not occur within 2 hrs	62	120	140	87

Population analysed: An "all-patients-treated" approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the 24 hours treatment period, and up to and including 7 days after the last dose of study therapy.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rizatriptan 5 mg	1 of 164 (0.6%)	62 of 164 (37.8%)	Not reported
Rizatriptan 10 mg	0 of 387 (0%)	159 of 387 (41.1%)	Not reported
Sumatriptan 100 mg	0 of 388 (0%)	188 of 388 (48.5%)	Not reported
Placebo	0 of 160 (0%)	51 of 160 (31.9%)	Not reported

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 19222588Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12.
Results publication: PubMed 11284463Tfelt-Hansen P, Teall J, Rodriguez F, Giacovazzo M, Paz J, Malbecq W, Block GA, Reines SA, Visser WH. Oral rizatriptan versus oral sumatriptan: a direct comparative study in the acute treatment of migraine. Rizatriptan 030 Study Group. Headache. 1998 Nov-Dec;38(10):748-55. doi: 10.1046/j.1526-4610.1998.3810748.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 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 10 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 14 Jul 2009). 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 Dose (time frame: 2 hours after dose). 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 NCT00898677, 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 3 Feb 2022.