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

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ClinicalTrials.gov Identifier: NCT00475514
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : February 19, 2014
Information provided by:
Endo Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Frovatriptan 2.5mg QD Drug: Frovatriptan 2.5 mg BID Drug: placebo Phase 3

Detailed Description:
See above

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : October 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Primary Outcome Measures :
  1. Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs

Secondary Outcome Measures :
  1. Incidence of MRM headache
  2. Maximum headache intensity
  3. Incidence of moderate or severe MRM headaches
  4. Number of MRM headache free days during treated PMPs
  5. Incidence of MRM headache associated symptoms (e.g. photophobia, phonophobia, nausea and vomiting)
  6. Functional impairment during treatment phase
  7. Time to onset (days) of MRM headache (during the treated PMP and until five days post treatment)
  8. Time to onset of first post-treatment migraine Incidence of intercurrent migraine outside of the peri-menstrual period Use of rescue medication

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that fit the criteria for 'difficult to treat'
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ClinicalTrials.gov Identifier: NCT00475514    
Other Study ID Numbers: VML 251-3MRM02
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014
Keywords provided by Endo Pharmaceuticals:
Menstrually-related Migraine Headache
'Difficult to Treat' as specified in protocol
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs