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Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00904098
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
Endo Pharmaceuticals

Study Description
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Brief Summary:
Females 18 years of age or older with at least one year history of menstrual migraine (MM) headaches participated in a Phase 4 clinical trial to evaluate the efficacy of frovatriptan when used at the early stage (International Headache Society [IHS] Grade 1) of MM compared with patients' current treatment.

Condition or disease Intervention/treatment Phase
Menstrual Migraine (MM) Headaches Drug: Frovatriptan Drug: Usual Care Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment)Of Menstrual Migraine
Study Start Date : September 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Frovatriptan
Frovatriptan 2.5 mg oral tablet
 Drug: Frovatriptan

This study employed a prospective, non-randomized, open-label single-sequence design. The study was conducted in two phases:

  1. A Usual Care phase (approximately 1 month in duration) included one menstrual period during which female patients treated all episodes of migraine headaches using their current treatment (referred to as the Baseline phase in the protocol)
  2. An Acute Treatment phase (approximately 1 month in duration), following the Usual Care phase, included one menstrual period during which female patients used frovatriptan 2.5 mg to treat all episodes of migraine headache when their headache reached IHS Grade 1. If needed, a second dose of frovatriptan 2.5 mg was administered; however, this second dose could not be administered within 2 hours of the initial dose (i.e., there must have been at least 2 hours between doses of frovatriptan). The total daily dose of frovatriptan was not to exceed 3 tablets over a 24-hour period.
Active Comparator: Usual Care
Usual care includes the current treatment used to treat all episodes of migraine headache
 Drug: Usual Care
Current treatment used to treat all migraine headaches


Outcome Measures
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Primary Outcome Measures :
  1. Headache pain severity [ Time Frame: Visit - V1(Day 0), V2 (Day 28), V3 (Day 56) ]

Secondary Outcome Measures :
  1. Occurrence and severity of MM symptoms associated with migraine headache pain (nausea, vomiting, photophobia, and phonophobia)
  2. Occurrence and severity of functional impairment during menstrual migraine
  3. Use of rescue medication and additional frovatriptan dose
  4. Patient satisfaction with treatment
  5. Patient preference of current vs. study treatment (end of study only)
  6. Safety as assessed by occurrence of AEs

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Had MM headaches occurring between Day -2 and Day +3 of menses
  2. Had at least one year history of MM headaches
  3. Had at least 8 MM headaches in the previous 12 menstrual cycles (1 year)
  4. Had regular predictable menstrual periods (28 ± 4 days)

Exclusion Criteria:

  1. Had a history of more than 15 headache days per month
  2. As part of current MM treatment, used intermittent prevention with an analgesic (e.g., naproxen for 5 days to prevent the onset of MM)
  3. Had a history of myocardial infarction, ischemic heart disease (or presented with symptoms or signs compatible with ischemic heart disease), coronary vasospasm (including Prinzmetal's variant angina), other significant underlying cardiovascular disease, or peripheral vascular disease
  4. Had significant cerebrovascular disease, including basilar or hemiplegic migraine
  5. Had uncontrolled hypertension: systolic blood pressure >180mmHg and diastolic blood pressure >95mmHg
  6. Had severe hepatic or renal insufficiency
  7. Used an analgesic medication (including both prescription and over-the-counter) for any reason >50% of days per month
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904098


Locations
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United States, Connecticut
Stratford, Connecticut, United States
United States, Florida
Clearwater, Florida, United States
Jacksonville, Florida, United States
Largo, Florida, United States
Tampa, Florida, United States
United States, New Jersey
Blackwood, New Jersey, United States
United States, New York
New York, New York, United States
Plainview, New York, United States
Vestal, New York, United States
United States, North Carolina
Burlington, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
West Chester, Ohio, United States
United States, Pennsylvania
Norristown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
St. Petersburg, Pennsylvania, United States
Upland, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Sr. Director Endo Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sr. Director, Clinical R&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00904098    
Other Study ID Numbers: EN3266-401
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010
Keywords provided by Endo Pharmaceuticals:
migraine
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Premenstrual Syndrome
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
 Neurologic Manifestations
Menstruation Disturbances
Pathologic Processes
Frovatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs