NCT00475514

Brief Summary

Although the predictability of an MRM headache attack lends itself to preventative treatment, there are currently no drugs specifically indicated for the prevention of MM. Such preventative therapies might be administered either short term (during the time around the period otherwise known as the peri-menstrual period or PMP) or continuously throughout the menstrual cycle. Frovatriptan has been developed for the management of migraine and is already licensed for use as an acute treatment for this condition. Previous well controlled clinical trials have highlighted the potential of frovatriptan as a short-term preventative medication for MM. This clinical trial was meant to further explore this indication for frovatriptan in an expanded population.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2004

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

Study Start

First participant enrolled

October 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

May 16, 2007

Last Update Submit

December 29, 2023

Conditions

Migraine

Keywords

Menstrually-related Migraine Headache'Difficult to Treat' as specified in protocol

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs

Secondary Outcomes (8)

  • Incidence of MRM headache

  • Maximum headache intensity

  • Incidence of moderate or severe MRM headaches

  • Number of MRM headache free days during treated PMPs

  • Incidence of MRM headache associated symptoms (e.g. photophobia, phonophobia, nausea and vomiting)

  • +3 more secondary outcomes

Interventions

Frovatriptan 2.5mg QDDRUG
Frovatriptan 2.5 mg BIDDRUG
placeboDRUG

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that fit the criteria for 'difficult to treat'

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Migraine Disorders

Interventions

frovatriptanBID protein, human

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 16, 2007

First Posted

May 21, 2007

Study Start

October 1, 2004

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

January 2, 2024

Record last verified: 2023-12