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

Tracking Information
First Received Date ^ICMJE	May 16, 2007
Last Updated Date	February 12, 2010
Start Date ^ICMJE	October 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: May 17, 2007)	Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00475514 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 17, 2007)	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
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine
Official Title ^ICMJE	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
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.
Detailed Description	See above
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Allocation: Randomized Control: Placebo Control Intervention Model: Parallel Assignment Masking: Double-Blind
Condition ^ICMJE	Migraine
Intervention ^ICMJE	Drug: Frovatriptan 2.5mg QD Drug: Frovatriptan 2.5 mg BID Drug: placebo
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	April 2006
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that fit the criteria for 'difficult to treat'
Gender	Female
Ages	15 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00475514
Responsible Party
Study ID Numbers ^ICMJE	VML 251-3MRM02
Study Sponsor ^ICMJE	Endo Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Endo Pharmaceuticals
Verification Date	February 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP