Migraine DisordersPhase 3NCT01286207

Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)

A Phase 3 study testing Rizatriptan 5 mg and Rizatriptan 10 mg in people with Migraine Disorders, 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

This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949); MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and migraine recurrence. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Migraine Disorders
What is being tested?: Rizatriptan 5 mg and Rizatriptan 10 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,959 participants
Where: No sites listed yet
Study dates: Mar 1995to May 1997
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 took part in study MK-0462-022, MK-0462-025, or MK-0462-029
History of migraine headache

Who cannot join

None listed.

About this study

Official title: Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Protocols 022, 025, 029)

Conditions: Migraine Disorders
Being tested: Rizatriptan 5 mg, Rizatriptan 10 mg, Standard Care
Keywords: Migraine headache
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 5 mgDrug
Also called MK-0462, Maxalt
Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
Rizatriptan 10 mgDrug
Also called MK-0462, Maxalt
Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
Standard CareDrug
Active standard care

Study groups in NCT01286207
Study group	Role	What they receive
Rizatriptan 5 mg	Experimental	Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) Receives: Drug: Rizatriptan 5 mg
Rizatriptan 10 mg	Experimental	Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) Receives: Drug: Rizatriptan 10 mg
Standard Care	Active comparator	Standard care at onset of migraine attack Receives: Drug: Standard Care

What is being measured

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

Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug
Headache severity was rated on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain) immediately before initial dose and at 2 hours thereafter. Pain relief was defined as a reduction of headache severity from grades 2/3 at baseline to 0/1.
Measured: 2 hours after initial dose of test drug
Number of Participants With Serious Clinical Adverse Experiences
Serious clinical adverse experiences (CAEs) are any adverse events (AEs) occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Measured: Up to 12 months
Number of Participants With Drug-related Clinical Adverse Experiences
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
Measured: Up to 12 months
Number of Participants Who Discontinued Due to Clinical Adverse Experiences
Measured: Up to 12 months
Number of Participants With Drug-related Lab Adverse Experiences
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) laboratory adverse experience (LAE).
A LAE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Measured: Up to 12 weeks

Timeline

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

Mar 1995May 1997

First posted31 Jan 2011 (estimated)
Study startMar 1995
Primary completionMay 1997
Study completionMay 1997

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.
Other trials for Migraine DisordersStudies 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: Single blind
Who is masked: Participant
Enrolment: 1,959 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01286207
Sponsor's protocol ID: 0462 Pooled 022/025/029
Status last verified: Feb 2022
First submitted: 27 Jan 2011
Last updated: 3 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 Migraine Disorders trials

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: Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Protocols 022, 025, 029)
ClinicalTrials.gov ID: NCT01286207
Acronym / sponsor ID: 0462 Pooled 022/025/029
Conditions: Migraine Disorders
Keywords: Migraine headache
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,959 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Mar 1995
Primary completion: May 1997 (actual)
Study completion: May 1997 (actual)
First posted: 31 Jan 2011 (estimated)
Results: Posted 10 Jun 2011

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: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Rizatriptan 5 mg	Experimental	Drug: Rizatriptan 5 mgRizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
Rizatriptan 10 mg	Experimental	Drug: Rizatriptan 10 mgRizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
Standard Care	Active comparator	Drug: Standard CareStandard care at onset of migraine attack

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029
History of migraine headache

Key exclusion criteria (0 listed)

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 5 mgAlso: MK-0462, MaxaltRizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)	Drug	Rizatriptan 5 mg
Rizatriptan 10 mgAlso: MK-0462, MaxaltRizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)	Drug	Rizatriptan 10 mg
Standard CareActive standard care	Drug	Standard Care

Primary outcome

Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug
Time frame: 2 hours after initial dose of test drug
Headache severity was rated on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain) immediately before initial dose and at 2 hours thereafter. Pain relief was defined as a reduction of headache severity from grades 2/3 at baseline to 0/1.
Number of Participants With Serious Clinical Adverse Experiences
Time frame: Up to 12 months
Serious clinical adverse experiences (CAEs) are any adverse events (AEs) occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Number of Participants With Drug-related Clinical Adverse Experiences
Time frame: Up to 12 months
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
Number of Participants Who Discontinued Due to Clinical Adverse Experiences
Time frame: Up to 12 months
Number of Participants With Drug-related Lab Adverse Experiences
Time frame: Up to 12 weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) laboratory adverse experience (LAE). A LAE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.

Results and safety

Results posted to the registry on 10 Jun 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 5 mg	751	453
Rizatriptan 10 mg	857	609
Standard Care	351	261

Primary outcome: Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug

Time frame: 2 hours after initial dose of test drug. Median (Inter-Quartile Range). Unit: percent of headaches

Measure	Rizatriptan 5 mg n = 606	Rizatriptan 10 mg n = 815	Standard Care n = 325
Value	80 (55.6 to 93.8)	89.5 (75.0 to 98.0)	69.6 (46.2 to 92.0)

Population analysed: All patients who took study medication and filled out their diary cards were included in the analysis of efficacy. No data were imputed.

Primary outcome: Number of Participants With Serious Clinical Adverse Experiences

Time frame: Up to 12 months. Number. Unit: participants

Measure	Rizatriptan 5 mg n = 711	Rizatriptan 10 mg n = 834	Standard Care n = 334
With Serious CAEs	13	17	10
Without Serious CAEs	698	817	324

Population analysed: All patients who took study medication were included in the analysis.

Primary outcome: Number of Participants With Drug-related Clinical Adverse Experiences

Time frame: Up to 12 months. Number. Unit: participants

Measure	Rizatriptan 5 mg n = 711	Rizatriptan 10 mg n = 834	Standard Care n = 334
With drug-related CAEs	288	456	139
Without drug-related CAEs	423	378	195

Population analysed: All patients who took study medication were included in the analysis.

Primary outcome: Number of Participants Who Discontinued Due to Clinical Adverse Experiences

Time frame: Up to 12 months. Number. Unit: participants

Measure	Rizatriptan 5 mg n = 711	Rizatriptan 10 mg n = 834	Standard Care n = 334
Discontinued due to CAEs	26	37	7
Not discontinued due to CAEs	685	797	327

Population analysed: All patients who took study medication were included in the analysis.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rizatriptan 5 mg	13 of 711 (1.8%)	492 of 711 (69.2%)	Not reported
Rizatriptan 10 mg	17 of 834 (2%)	679 of 834 (81.4%)	Not reported
Standard Care	10 of 334 (3%)	267 of 334 (79.9%)	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.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rizatriptan 5 mg and Rizatriptan 10 mg in people with Migraine Disorders, 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 2 inclusion and 0 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. 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 10 Jun 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?

Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug (time frame: 2 hours after initial dose of test drug). The study lists 5 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 NCT01286207.

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.