MigrainePhase 3NCT00516737

Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

A Phase 3 study testing Comparator: rizatriptan benzoate in people with 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

The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Migraine
What is being tested?: Comparator: rizatriptan benzoate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 207 participants
Where: No sites listed yet
Study dates: 3 Oct 2007to 8 Apr 2008
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

Greater than one year history of migraine
Attacks typically mild when they begin and progress to moderate or severe
Experience 1-4 migraine attacks per month

Who cannot join

More than 15 headache days per month
Heart disease
Uncontrolled high blood pressure

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine

The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.

Conditions: Migraine
Being tested: Comparator: rizatriptan benzoate, 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.

Comparator: rizatriptan benzoateDrug
Also called MK0462
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Comparator: PlaceboDrug
Matching placebo; one dose, treatment of a single migraine attack

Study groups in NCT00516737
Study group	Role	What they receive
1	Experimental	Active Drug Receives: Drug: Comparator: rizatriptan benzoate
2	Placebo comparator	Matching Pbo Comparator Receives: Drug: Comparator: Placebo

What is being measured

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

Number of Participants Who Are Pain Free at 2 Hours Post-Dose
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.
Measured: 2 hours post-dose

Secondary outcomes (6)

Number of Participants With 24-Hour Sustained Pain Freedom
24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.
Measured: 24 hours post-dose
Number of Participants With no Rescue Use up to 24 Hours Post-Dose
Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.
Measured: 24 hours post-dose
Number of Participants With Absence of Photophobia at 2 Hours Post-dose
Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.
Measured: 2 hours post-dose
Number of Participants With Absence of Phonophobia at 2 Hours Post-dose
Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.
Measured: 2 hours post-dose
Number of Participants With Absence of Nausea at 2 Hours Post-dose
Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.
Measured: 2 hours post-dose
Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose
Level of functional disability was assessed on a paper diary by the participants.
Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours 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.

3 Oct 20078 Apr 2008

First posted15 Aug 2007 (estimated)
Study start3 Oct 2007
Primary completion8 Apr 2008
Study completion8 Apr 2008

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 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: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00516737
Sponsor's protocol ID: 0462-081
Other IDs: 2007_547
Status last verified: Feb 2022
First submitted: 13 Aug 2007
Last updated: 22 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Cady RK, Martin VT, Geraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96. doi: 10.1111/j.1526-4610.2009.01412.x.
PubMed 19472447

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

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine
ClinicalTrials.gov ID: NCT00516737
Acronym / sponsor ID: 0462-081
Conditions: Migraine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 3 Oct 2007 (actual)
Primary completion: 8 Apr 2008 (actual)
Study completion: 8 Apr 2008 (actual)
First posted: 15 Aug 2007 (estimated)
Results: Posted 14 Apr 2009

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 rizatriptan benzoate in the early treatment of an acute migraine attack.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Comparator: rizatriptan benzoateActive Drug
2	Placebo comparator	Drug: Comparator: PlaceboMatching Pbo Comparator

Who may qualify

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

Key inclusion criteria (3 listed)

Greater than one year history of migraine
Attacks typically mild when they begin and progress to moderate or severe
Experience 1-4 migraine attacks per month

Key exclusion criteria (3 listed)

More than 15 headache days per month
Heart disease
Uncontrolled high blood pressure

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
Comparator: rizatriptan benzoateAlso: MK0462Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Drug	1
Comparator: PlaceboMatching placebo; one dose, treatment of a single migraine attack	Drug	2

Primary outcome

Number of Participants Who Are Pain Free at 2 Hours Post-Dose
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), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.

6 secondary outcomes

Number of Participants With 24-Hour Sustained Pain Freedom
Time frame: 24 hours post-dose
Number of Participants With no Rescue Use up to 24 Hours Post-Dose
Time frame: 24 hours post-dose
Number of Participants With Absence of Photophobia at 2 Hours Post-dose
Time frame: 2 hours post-dose
Number of Participants With Absence of Phonophobia at 2 Hours Post-dose
Time frame: 2 hours post-dose
Number of Participants With Absence of Nausea at 2 Hours Post-dose
Time frame: 2 hours post-dose
Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose
Time frame: 2 hours post-dose

Results and safety

Results posted to the registry on 14 Apr 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 10 mg ODT	103	92
Placebo	104	96

Primary outcome: Number of Participants Who Are Pain Free at 2 Hours Post-Dose

Time frame: 2 hours post-dose. Number. Unit: Participants

Measure	Rizatriptan 10 mg ODT n = 92	Placebo n = 96
Value	61	27

Population analysed: Full Analysis Set (FAS): The FAS population includes all randomized participants who have at least one assessment within 2 hours post-dose (i.e., after baseline assessment).

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rizatriptan 10 mg ODT	0 of 92 (0%)	6 of 92 (6.5%)	Not reported
Placebo	0 of 96 (0%)	3 of 96 (3.1%)	Not reported

Limitations and caveats (from the sponsor): In the Adverse Events section, all non-serious adverse experiences reported are post-treatment, up to the time of taking rescue medication or 14 days post-dose, whichever comes first.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19472447Cady RK, Martin VT, Geraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96. doi: 10.1111/j.1526-4610.2009.01412.x.
Individual participant dataSharing planned: No

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

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 Comparator: rizatriptan benzoate 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 22 Apr 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. 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 Apr 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?

Number of Participants Who Are Pain Free at 2 Hours Post-Dose (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 NCT00516737, 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 22 Apr 2024.