Trial · NCT01286207

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

NCT01286207, Phase 3, Completed, Organon and Co; results first posted 2011-06-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029). Trials, record NCT01286207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01286207

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)
NCT number: NCT01286207
Status: Completed
Phases: Phase 3
Enrollment: 1,959 participants, actual
Lead sponsor: Organon and Co
Conditions: Migraine Disorders
Interventions: Rizatriptan 5 mg, Rizatriptan 10 mg, Standard Care
First posted: 2011-01-31
Last updated: 2022-02-03
Results first posted: 2011-06-10

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug	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.
Primary	Number of Participants With Serious Clinical Adverse Experiences	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.
Primary	Number of Participants With Drug-related Clinical Adverse Experiences	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.
Primary	Number of Participants Who Discontinued Due to Clinical Adverse Experiences	Up to 12 months
Primary	Number of Participants With Drug-related Lab Adverse Experiences	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug	2 hours after initial dose of test drug	All patients who took study medication and filled out their diary cards were included in the analysis of efficacy. No data were imputed.	percent of headaches	MEDIAN
PRIMARY	Number of Participants With Serious Clinical Adverse Experiences	Up to 12 months	All patients who took study medication were included in the analysis.	participants	NUMBER
PRIMARY	Number of Participants With Drug-related Clinical Adverse Experiences	Up to 12 months	All patients who took study medication were included in the analysis.	participants	NUMBER
PRIMARY	Number of Participants Who Discontinued Due to Clinical Adverse Experiences	Up to 12 months	All patients who took study medication were included in the analysis.	participants	NUMBER
PRIMARY	Number of Participants With Drug-related Lab Adverse Experiences	Up to 12 weeks	All patients who took study medication and had lab test(s)were included in the analysis.	participants	NUMBER

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug	Rizatriptan 5 mg		80	Inter-Quartile Range 55.6 to 93.8	percent of headaches
Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug	Rizatriptan 10 mg		89.5	Inter-Quartile Range 75.0 to 98.0	percent of headaches
Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug	Standard Care		69.6	Inter-Quartile Range 46.2 to 92.0	percent of headaches
Number of Participants With Serious Clinical Adverse Experiences	Rizatriptan 5 mg	With Serious CAEs	13		participants
Number of Participants With Serious Clinical Adverse Experiences	Rizatriptan 10 mg	With Serious CAEs	17		participants
Number of Participants With Serious Clinical Adverse Experiences	Standard Care	With Serious CAEs	10		participants
Number of Participants With Serious Clinical Adverse Experiences	Rizatriptan 5 mg	Without Serious CAEs	698		participants
Number of Participants With Serious Clinical Adverse Experiences	Rizatriptan 10 mg	Without Serious CAEs	817		participants
Number of Participants With Serious Clinical Adverse Experiences	Standard Care	Without Serious CAEs	324		participants
Number of Participants With Drug-related Clinical Adverse Experiences	Rizatriptan 5 mg	With drug-related CAEs	288		participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Rizatriptan 5 mg	751
Overall Study	STARTED	Rizatriptan 10 mg	857
Overall Study	STARTED	Standard Care	351
Overall Study	COMPLETED	Rizatriptan 5 mg	453
Overall Study	COMPLETED	Rizatriptan 10 mg	609
Overall Study	COMPLETED	Standard Care	261
Overall Study	NOT COMPLETED	Rizatriptan 5 mg	298
Overall Study	NOT COMPLETED	Rizatriptan 10 mg	248
Overall Study	NOT COMPLETED	Standard Care	90

Source ClinicalTrials.gov

Adverse events168

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Asthenia/fatigue	General disorders	Rizatriptan 5 mg	70	711
other	Asthenia/fatigue	General disorders	Rizatriptan 10 mg	111	834
other	Asthenia/fatigue	General disorders	Standard Care	44	334
other	Pain, abdominal	General disorders	Rizatriptan 5 mg	24	711
other	Pain, abdominal	General disorders	Rizatriptan 10 mg	27	834
other	Pain, abdominal	General disorders	Standard Care	18	334
other	Pain, chest	General disorders	Rizatriptan 5 mg	34	711
other	Pain, chest	General disorders	Rizatriptan 10 mg	61	834
other	Pain, chest	General disorders	Standard Care	28	334
other	Diarrhea	Gastrointestinal disorders	Rizatriptan 5 mg	21	711

1 to 10 of 168Source ClinicalTrials.gov

See all 168 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rizatriptan 5 mg
Total, all-cause mortality	Rizatriptan 10 mg
Total, all-cause mortality	Standard Care
Total, other adverse events	Rizatriptan 5 mg	492	711
Total, other adverse events	Rizatriptan 10 mg	679	834
Total, other adverse events	Standard Care	267	334
Total, serious adverse events	Rizatriptan 5 mg	13	711
Total, serious adverse events	Rizatriptan 10 mg	17	834
Total, serious adverse events	Standard Care	10	334

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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API reference For AI assistants