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

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904098
First received: May 15, 2009
Last updated: February 12, 2010
Last verified: February 2010
History of Changes
  Purpose

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 Intervention Phase
Menstrual Migraine (MM) Headaches
 Drug: Frovatriptan
Drug: Usual Care
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment)Of Menstrual Migraine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Headache pain severity [ Time Frame: Visit - V1(Day 0), V2 (Day 28), V3 (Day 56) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence and severity of MM symptoms associated with migraine headache pain (nausea, vomiting, photophobia, and phonophobia) [ Designated as safety issue: No ]
  • Occurrence and severity of functional impairment during menstrual migraine [ Designated as safety issue: No ]
  • Use of rescue medication and additional frovatriptan dose [ Designated as safety issue: No ]
  • Patient satisfaction with treatment [ Designated as safety issue: No ]
  • Patient preference of current vs. study treatment (end of study only) [ Designated as safety issue: No ]
  • Safety as assessed by occurrence of AEs [ Designated as safety issue: Yes ]

Enrollment: 192
Study Start Date: September 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904098

Locations
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
Study Director: Sr. Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sr. Director, Clinical R&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00904098     History of Changes
Other Study ID Numbers: EN3266-401
Study First Received: May 15, 2009
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
migraine

Additional relevant MeSH terms:
Menstruation Disturbances
Headache
Migraine Disorders
Premenstrual Syndrome
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Pathologic Processes
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 May 19, 2013