NCT00111722

Brief Summary

The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
393

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2005

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2005

Completed
2 days until next milestone

Study Start

First participant enrolled

May 27, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2006

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2006

Completed
Last Updated

August 14, 2024

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

May 24, 2005

Last Update Submit

August 12, 2024

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

MK0462, rizatriptan benzoate / Duration of Treatment -1dayDRUG
Comparator: placebo / Duration of Treatment - 1 dayDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Mannix LK, Loder E, Nett R, Mueller L, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies. Cephalalgia. 2007 May;27(5):414-21. doi: 10.1111/j.1468-2982.2007.01313.x.

    PMID: 17448179BACKGROUND

  • Nett R, Mannix LK, Mueller L, Rodgers A, Hustad CM, Skobieranda F, Ramsey KE. Rizatriptan efficacy in ICHD-II pure menstrual migraine and menstrually related migraine. Headache. 2008 Sep;48(8):1194-201. doi: 10.1111/j.1526-4610.2008.01093.x. Epub 2008 Apr 14.

    PMID: 18422606BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

rizatriptanDuration of Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2005

First Posted

May 25, 2005

Study Start

May 27, 2005

Primary Completion

February 15, 2006

Study Completion

February 23, 2006

Last Updated

August 14, 2024

Record last verified: 2022-02