Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches
This study has been completed.
Sponsor:
Endo Pharmaceuticals
Collaborator:
Vernalis (R&D) Ltd
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01035983
First received: December 17, 2009
Last updated: February 12, 2010
Last verified: February 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Migraine |
Drug: Frovatriptan 2.5 mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by Endo Pharmaceuticals:
Primary Outcome Measures:
- Incidence of all treatment-emergent adverse events (AEs). [ Time Frame: 9-15 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of menstrual migraine headache [ Time Frame: 9-15 months ] [ Designated as safety issue: No ]
- Maximum headache severity [ Time Frame: 9-15 months ] [ Designated as safety issue: No ]
- Number of headache-free days during a treated perimenstrual period (PMP) [ Time Frame: 9-15 months ] [ Designated as safety issue: No ]
- Occurrence and severity of menstrual migraine headache-associated symptoms [ Time Frame: 9-15 months ] [ Designated as safety issue: No ]
- Maximum functional impairment during menstrual migraine headache [ Time Frame: 9-15 months ] [ Designated as safety issue: No ]
- Incidence and severity of intercurrent migraine [ Time Frame: 9-15 months ] [ Designated as safety issue: No ]
- Total migraine burden [ Time Frame: 9-15 months ] [ Designated as safety issue: No ]
- Standard hematology and biochemistry [ Time Frame: 9-15 months ] [ Designated as safety issue: Yes ]
- 12-lead electrocardiogram (ECG) and vital signs, physical examination [ Time Frame: 9-15 months ] [ Designated as safety issue: Yes ]
- Short-form 12 (SF-12) Health Related Quality of Life Questionnaire [ Time Frame: 9-12 months ] [ Designated as safety issue: No ]
| Enrollment: | 550 |
| Study Start Date: | December 2003 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035983
Locations
| Germany | |
| Munich, Germany | |
| Hungary | |
| Budapest, Hungary | |
| Poland | |
| Warsaw, Poland | |
| South Africa | |
| Cape Town, South Africa | |
| United Kingdom | |
| London, United Kingdom | |
Sponsors and Collaborators
Endo Pharmaceuticals
Vernalis (R&D) Ltd
Investigators
| Principal Investigator: | Anne MacGregor, DIPM MFFP | City of London Migraine Clinic |
More Information
Publications:
| Responsible Party: | John C. Campbell, Director, Medical Affairs, Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01035983 History of Changes |
| Other Study ID Numbers: | VML 251-3MAM03 |
| Study First Received: | December 17, 2009 |
| Last Updated: | February 12, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Endo Pharmaceuticals:
|
menstrually associated migraine (MAM), Migraines,Menstrual Migraines, menstrually related migraines |
Additional relevant MeSH terms:
|
Headache Migraine Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases 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 21, 2013