A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine - Full Text View

Sponsor:	Endo Pharmaceuticals
Information provided by:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00475514

Purpose

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.

Condition	Intervention	Phase
Migraine	Drug: Frovatriptan 2.5mg QD Drug: Frovatriptan 2.5 mg BID Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind
Official Title:	A Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, and Safety of Oral Frovatriptan in the Prevention on Menstrually-related Migraine (MRM) Headaches in a 'Difficult to Treat' Population

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Menstruation Migraine Nausea and Vomiting

Drug Information available for: Frovatriptan Frovatriptan succinate

U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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)
Functional impairment during treatment phase
Time to onset (days) of MRM headache (during the treated PMP and until five days post treatment)
Time to onset of first post-treatment migraine Incidence of intercurrent migraine outside of the peri-menstrual period Use of rescue medication

Study Start Date:	October 2004
Study Completion Date:	April 2006

Detailed Description:

See above

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00475514 History of Changes
Other Study ID Numbers:	VML 251-3MRM02
Study First Received:	May 16, 2007
Last Updated:	February 12, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:

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

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Frovatriptan

Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012