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Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches (MAM)

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: NCT01035983
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : February 15, 2010
Vernalis (R&D) Ltd
Information provided by:
Endo Pharmaceuticals

Brief Summary:
In this open-label, multi-center study, patients were treated with frovatriptan for a maximum of 12 perimenstrual periods (PMPs). For each PMP, dosing commenced 2 days before the anticipated onset of the menstrual migraine (MM) headache and continued for a total of 6 days. Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6. During the study, patients were to visit the study site a total of 6 times. Efficacy and/or safety assessments were performed at each visit.

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

Detailed Description:
This Phase IIIb, open label, multi-centre study evaluated the safety and tolerability of frovatriptan taken by patients for up to 12 perimenstrual periods (PMPs) for the prevention of menstrual migraine (MM). The study required approximately 300 patients to treat 6 PMPs and 100 patients to treat 12 PMPs. To achieve these numbers, 550 patients were to be enrolled into the study. Once enrolled, patients were requested to treat at least 6 PMPs in the first 9 months and 12 PMPs overall. Patients were to remain in the study for a maximum of 15 months or until they had completed the treatment of 12 PMPs, whichever occurred sooner.Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Assess the Safety, Tolerability and Efficacy of Frovatriptan in the Prevention of Menstrually Associated Migraine (MAM) Headaches.
Study Start Date : December 2003
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Frovatriptan 2.5 mg
Frovatriptan 2.5 mg tablets administered orally 2 x 2.5 mg twice daily (loading dose) on day 1, followed by 2.5 mg twice daily days 2 to 6.
Drug: Frovatriptan 2.5 mg

Primary Outcome Measures :
  1. Incidence of all treatment-emergent adverse events (AEs). [ Time Frame: 9-15 months ]

Secondary Outcome Measures :
  1. Incidence of menstrual migraine headache [ Time Frame: 9-15 months ]
  2. Maximum headache severity [ Time Frame: 9-15 months ]
  3. Number of headache-free days during a treated perimenstrual period (PMP) [ Time Frame: 9-15 months ]
  4. Occurrence and severity of menstrual migraine headache-associated symptoms [ Time Frame: 9-15 months ]
  5. Maximum functional impairment during menstrual migraine headache [ Time Frame: 9-15 months ]
  6. Incidence and severity of intercurrent migraine [ Time Frame: 9-15 months ]
  7. Total migraine burden [ Time Frame: 9-15 months ]
  8. Standard hematology and biochemistry [ Time Frame: 9-15 months ]
  9. 12-lead electrocardiogram (ECG) and vital signs, physical examination [ Time Frame: 9-15 months ]
  10. Short-form 12 (SF-12) Health Related Quality of Life Questionnaire [ Time Frame: 9-12 months ]

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:

  • Female aged 15 years and over (≥18 years in United Kingdom and South Africa), with at least a 12 month documented history of experiencing migraine according to IHS criteria, including confirmation of a 3 month diary based documented history of MAM.
  • An average frequency of MAM in at least two out of three menstrual cycles, within the previous 12 months
  • Regular, predictable menstrual periods
  • MAM headaches occurring between Day -2 and day +4 of menses
  • Able and willing to sign informed consent and to comply with study procedures, including completion of the diary cards.

Exclusion Criteria:

  • More than three migraine attacks per month that were not MAM attacks
  • A history of myocardial infarction, ischemic heart disease (or presenting with symptoms or signs compatible with ischemic heart disease), coronary vasospasm or peripheral vascular disease
  • Significant cerebrovascular disease including basilar or hemiplegic migraine
  • Uncontrolled hypertension (SBP >180 mmHg, DBP >95 mmHg)
  • Severe hepatic or renal insufficiency
  • More than 15 headache days per month, exclusive of migraine headache
  • Any other condition or serious illness which, in the opinion of the investigator, would interfere with optimal participation in the study
  • A history of clinically relevant allergy, including that to frovatriptan or other triptans
  • Pregnant or breast-feeding, or intending to become pregnant or breast-feed during the study period (patients were to be using adequate contraception and have a negative pregnancy test at screening)
  • Treatment with another investigational drug within 30 days or 5 half-lives (whichever was longer) before the screening visit
  • Any change in their oral contraceptive medication (if applicable) in the 2 months prior to screening, or anticipation of any change during study participation
  • Any change in the type or dose of any prophylactic migraine medication in the 2 months prior to screening, or anticipation of any change during study participation
  • A history of migraine with aura, according to IHS criteria, and currently treated with a combined oral contraceptive (South Africa only).

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): NCT01035983

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Munich, Germany
Budapest, Hungary
Warsaw, Poland
South Africa
Cape Town, South Africa
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Endo Pharmaceuticals
Vernalis (R&D) Ltd
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Principal Investigator: Anne MacGregor, DIPM MFFP City of London Migraine Clinic
Publications of Results:
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Responsible Party: John C. Campbell, Director, Medical Affairs, Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01035983    
Other Study ID Numbers: VML 251-3MAM03
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010
Keywords provided by Endo Pharmaceuticals:
menstrually associated migraine (MAM), Migraines,Menstrual Migraines, menstrually related migraines
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs