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

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Frovatriptan 2.5 mg
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring menstrually associated migraine (MAM), Migraines,Menstrual Migraines, menstrually related migraines

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Frovatriptan 2.5 mg

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of all treatment-emergent adverse events (AEs).

Secondary Outcome Measures

Incidence of menstrual migraine headache
Maximum headache severity
Number of headache-free days during a treated perimenstrual period (PMP)
Occurrence and severity of menstrual migraine headache-associated symptoms
Maximum functional impairment during menstrual migraine headache
Incidence and severity of intercurrent migraine
Total migraine burden
Standard hematology and biochemistry
12-lead electrocardiogram (ECG) and vital signs, physical examination
Short-form 12 (SF-12) Health Related Quality of Life Questionnaire

Full Information

First Posted
December 17, 2009
Last Updated
February 12, 2010
Sponsor
Endo Pharmaceuticals
Collaborators
Vernalis (R&D) Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01035983
Brief Title
Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches
Acronym
MAM
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 Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Endo Pharmaceuticals
Collaborators
Vernalis (R&D) Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
menstrually associated migraine (MAM), Migraines,Menstrual Migraines, menstrually related migraines

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
550 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Frovatriptan 2.5 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Frovatriptan 2.5 mg
Primary Outcome Measure Information:
Title
Incidence of all treatment-emergent adverse events (AEs).
Time Frame
9-15 months
Secondary Outcome Measure Information:
Title
Incidence of menstrual migraine headache
Time Frame
9-15 months
Title
Maximum headache severity
Time Frame
9-15 months
Title
Number of headache-free days during a treated perimenstrual period (PMP)
Time Frame
9-15 months
Title
Occurrence and severity of menstrual migraine headache-associated symptoms
Time Frame
9-15 months
Title
Maximum functional impairment during menstrual migraine headache
Time Frame
9-15 months
Title
Incidence and severity of intercurrent migraine
Time Frame
9-15 months
Title
Total migraine burden
Time Frame
9-15 months
Title
Standard hematology and biochemistry
Time Frame
9-15 months
Title
12-lead electrocardiogram (ECG) and vital signs, physical examination
Time Frame
9-15 months
Title
Short-form 12 (SF-12) Health Related Quality of Life Questionnaire
Time Frame
9-12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne MacGregor, DIPM MFFP
Organizational Affiliation
City of London Migraine Clinic
Official's Role
Principal Investigator
Facility Information:
City
Munich
Country
Germany
City
Budapest
Country
Hungary
City
Warsaw
Country
Poland
City
Cape Town
Country
South Africa
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19788471
Citation
MacGregor EA, Brandes JL, Silberstein S, Jeka S, Czapinski P, Shaw B, Pawsey S. Safety and tolerability of short-term preventive frovatriptan: a combined analysis. Headache. 2009 Oct;49(9):1298-314. doi: 10.1111/j.1526-4610.2009.01513.x.
Results Reference
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Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches

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