- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01035983
Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches (MAM)
December 29, 2023 updated by: Endo Pharmaceuticals
An Open Label Study to Assess the Safety, Tolerability and Efficacy of Frovatriptan in the Prevention of Menstrually Associated Migraine (MAM) Headaches.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
550
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Munich, Germany
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Budapest, Hungary
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Warsaw, Poland
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Cape Town, South Africa
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London, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of all treatment-emergent adverse events (AEs).
Time Frame: 9-15 months
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9-15 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of menstrual migraine headache
Time Frame: 9-15 months
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9-15 months
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Maximum headache severity
Time Frame: 9-15 months
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9-15 months
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Number of headache-free days during a treated perimenstrual period (PMP)
Time Frame: 9-15 months
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9-15 months
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Occurrence and severity of menstrual migraine headache-associated symptoms
Time Frame: 9-15 months
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9-15 months
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Maximum functional impairment during menstrual migraine headache
Time Frame: 9-15 months
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9-15 months
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Incidence and severity of intercurrent migraine
Time Frame: 9-15 months
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9-15 months
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Total migraine burden
Time Frame: 9-15 months
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9-15 months
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Standard hematology and biochemistry
Time Frame: 9-15 months
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9-15 months
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12-lead electrocardiogram (ECG) and vital signs, physical examination
Time Frame: 9-15 months
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9-15 months
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Short-form 12 (SF-12) Health Related Quality of Life Questionnaire
Time Frame: 9-12 months
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9-12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne MacGregor, DIPM MFFP, City of London Migraine Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
December 17, 2009
First Submitted That Met QC Criteria
December 18, 2009
First Posted (Estimated)
December 21, 2009
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 29, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Headache
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Serotonin Agents
- Serotonin Receptor Agonists
- Frovatriptan
Other Study ID Numbers
- VML 251-3MAM03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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