Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-072)

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg Tablets for the Treatment of Menstrual Migraine

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00111722

Enrollment

393

Registered

2005-05-25

Start date

2005-05-27

Completion date

2006-02-23

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 a marketed drug in the treatment of a menstrual migraine attack.

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

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Female patient at least 18 years old * Patient has menses approximately monthly * Patient has at least a 6 month history of migraine and at least a 6 month history of menstrual migraine

Exclusion criteria

* Pregnant and/or nursing mother * Cardiovascular disease * Uncontrolled hypertension

Design outcomes

Primary

Measure	Time frame
Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary	—

Secondary

Measure	Time frame
Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose recorded in patient diary	—

Outcome results

None listed

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