Study to Test an Approved Product in the Early Treatment of Migraine (0462-065)

A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Examine the Efficacy of Rizatriptan 10 mg Tablet Administered Early During a Migraine Attack While the Pain is Mild

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092963

Enrollment

529

Registered

2004-09-29

Start date

2004-08-17

Completion date

2005-01-14

Last updated

2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Brief summary

The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine while the pain is still mild.

Interventions

DRUGMK0462, rizatriptan benzoate / Duration of Treatment: 1day

DRUGComparator: placebo / Duration of Treatment: 1 day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 6-month history of migraine * Migraine attacks typically mild when they begin with 1-4 migraine attacks per month

Exclusion criteria

* Heart disease * High blood pressure

Design outcomes

Primary

Measure	Time frame
Percentage of patients who are pain free at 2 hours postdose.	—
Tolerability as measured by subjective adverse experience reporting.	—

Secondary

Measure	Time frame
Percentage of patients with associated symptoms at 2 hours	—
Percentage of patients with 24 hour sustained pain freedom	—
Percentage of patients with functional disability at 2 hours	—
Percentage of patients requiring rescue med between 2 & 24 hours	—
Percentage of patients free at 30/45/60/90 minutes postdose	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026