Acute MigrainePhase 3NCT00894556

A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)

A Phase 3 study testing rizatriptan and Comparator: Sumatriptan in people with Acute Migraine, run by Organon and Co.

Completed

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

Trial summary

A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Migraine
What is being tested?: rizatriptan 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: 109 participants
Where: No sites listed yet
Study dates: 10 Jun 2009to 12 Jan 2010
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month
Patient generally does not respond to treatment with sumatriptan
Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study
Patient is able to complete paper diary

Who cannot join

Patient is pregnant or breast feeding or excepts to become pregnant during the study
Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
Patient has basilar or hemiplegic migraines
Patient is unable to distinguish between migraine attacks from other types of headaches
Patient has more than 15 headache-days per month
Patient was greater than 50 years old at age of migraine onset

Show all 15Show fewer

Patient has failed to respond to 3 or more triptans
Patient has a repeated history of failing to respond to or tolerate rizatriptan
Patient uses opioids as primary migraine therapy
Patient uses daily opioids
Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease
Patient has uncontrolled hypertension
Patient has a history of neoplastic disease
Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening
Patient has a history of drug or alcohol abuse

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg for the Treatment of Acute Migraine in Sumatriptan Non-Responders

A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.

Conditions: Acute Migraine
Being tested: rizatriptan, Comparator: Placebo, Comparator: Sumatriptan
Keywords: Treatment of acute migraine with or without aura in adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rizatriptanDrug
Single dose of 10 mg orally disintegrating tablet at onset of migraine attack
Comparator: PlaceboDrug
Placebo to Rizatriptan
Comparator: SumatriptanDrug
single dose of generic sumatriptan 100 mg at onset of migraine attack

Study groups in NCT00894556
Study group	Role	What they receive
Treatment Sequence A	Experimental	Rizatriptan - Rizatriptan - Placebo Receives: Drug: rizatriptan; Drug: Comparator: Placebo
Treatment Sequence B	Experimental	Rizatriptan - Placebo - Rizatriptan Receives: Drug: rizatriptan; Drug: Comparator: Placebo
Treatment Sequence C	Experimental	Placebo - Rizatriptan - Rizatriptan Receives: Drug: rizatriptan; Drug: Comparator: Placebo
Baseline Phase	Other	Sumatriptan Receives: Drug: Comparator: Sumatriptan

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Relief (PR)
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.
Measured: 2 hours post dose

Secondary outcomes (1)

Pain Freedom (PF)
Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.
Measured: 2 hours post dose

Timeline

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

10 Jun 200912 Jan 2010

First posted7 May 2009 (estimated)
Study start10 Jun 2009
Primary completion12 Jan 2010
Study completion12 Jan 2010

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 (1)Papers the sponsor has linked to this study.
Other trials for Acute 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00894556
Sponsor's protocol ID: 0462-087
Other IDs: 2009_587
Status last verified: Feb 2022
First submitted: 5 May 2009
Last updated: 10 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Seeburger JL, Taylor FR, Friedman D, Newman L, Ge Y, Zhang Y, Hustad CM, Lasorda J, Fan X, Hewitt D, Ho T, Connor KM. Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders. Cephalalgia. 2011 May;31(7):786-96. doi: 10.1177/0333102410390399. Epub 2010 Nov 15.
PubMed 21078681

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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All Acute Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg for the Treatment of Acute Migraine in Sumatriptan Non-Responders
ClinicalTrials.gov ID: NCT00894556
Acronym / sponsor ID: 0462-087
Conditions: Acute Migraine
Keywords: Treatment of acute migraine with or without aura in adults
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 10 Jun 2009 (actual)
Primary completion: 12 Jan 2010 (actual)
Study completion: 12 Jan 2010 (actual)
First posted: 7 May 2009 (estimated)
Results: Posted 20 Jan 2011

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 provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.

Study design

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

Arm	Type	Receives
Treatment Sequence A	Experimental	Drug: rizatriptan, Drug: Comparator: PlaceboRizatriptan - Rizatriptan - Placebo
Treatment Sequence B	Experimental	Drug: rizatriptan, Drug: Comparator: PlaceboRizatriptan - Placebo - Rizatriptan
Treatment Sequence C	Experimental	Drug: rizatriptan, Drug: Comparator: PlaceboPlacebo - Rizatriptan - Rizatriptan
Baseline Phase	Other	Drug: Comparator: SumatriptanSumatriptan

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month
Patient generally does not respond to treatment with sumatriptan
Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study
Patient is able to complete paper diary

Key exclusion criteria (15 listed)

Patient is pregnant or breast feeding or excepts to become pregnant during the study
Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
Patient has basilar or hemiplegic migraines
Patient is unable to distinguish between migraine attacks from other types of headaches
Patient has more than 15 headache-days per month

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
rizatriptanSingle dose of 10 mg orally disintegrating tablet at onset of migraine attack	Drug	Treatment Sequence A, Treatment Sequence B, Treatment Sequence C
Comparator: PlaceboPlacebo to Rizatriptan	Drug	Treatment Sequence A, Treatment Sequence B, Treatment Sequence C
Comparator: Sumatriptansingle dose of generic sumatriptan 100 mg at onset of migraine attack	Drug	Baseline Phase

Primary outcome

Pain Relief (PR)
Time frame: 2 hours post dose
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.

1 secondary outcome

Pain Freedom (PF)
Time frame: 2 hours post dose

Results and safety

Results posted to the registry on 20 Jan 2011, 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 / Rizatriptan / Placebo	0	0
Rizatriptan / Placebo / Rizatriptan	0	0
Placebo / Rizatriptan / Rizatriptan	0	0
Sumatriptan 100 mg	194	109

Primary outcome: Pain Relief (PR)

Time frame: 2 hours post dose. Number. Unit: attacks

Measure	Rizatriptan n = 102	Placebo n = 99
Resulting in PR at 2 hours post dose	102	21
Not resulting in PR at 2 hours post dose	100	78

Rizatriptan vs Placebo: p <0.001, Generalized Linear Mixed Model (GLIMMIX)

Population analysed: The FAS population included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack the participant must have administered study treatment for this attack and must have had both a baseline severity measurement and at least one post-dose efficacy measurement prior to or including the 2-hour time point.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rizatriptan 10 mg	0 of 102 (0%)	18 of 102 (17.6%)	Not reported
Placebo	0 of 100 (0%)	3 of 100 (3%)	Not reported
Sumatriptan 100 mg	0 of 194 (0%)	29 of 194 (14.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21078681Seeburger JL, Taylor FR, Friedman D, Newman L, Ge Y, Zhang Y, Hustad CM, Lasorda J, Fan X, Hewitt D, Ho T, Connor KM. Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders. Cephalalgia. 2011 May;31(7):786-96. doi: 10.1177/0333102410390399. Epub 2010 Nov 15.
Individual participant dataSharing planned: No

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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 and Comparator: Sumatriptan in people with Acute 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 4 inclusion and 15 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 10 May 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?

Yes. Results are posted in the registry (first posted 20 Jan 2011). 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 (PR) (time frame: 2 hours post dose). 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 NCT00894556, which also lists 1 linked publication.

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 10 May 2024.