E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Menstrually-Related Migraine (MRM) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- The primary objective of the study is to determine whether frovatriptan taken for 6 days, starting 2 days prior to the expected onset of a MRM headache, is effective in the prevention of MRM headaches compared to placebo, in a ‘difficult to treat population’. |
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E.2.2 | Secondary objectives of the trial |
- To determine the effect of frovatriptan 2.5 mg od and 2.5 mg bd on the incidence, and severity of MRM headaches and associated symptoms over consecutive treated peri-menstrual periods (PMPs).
- To determine if frovatriptan increases incidence of migraine headaches outside of the treated peri-menstrual period.
- To evaluate the safety and tolerability of frovatriptan 2.5 mg od and 2.5 mg bd as short-term prophylaxis.
- To determine the effect of frovatriptan on health related quality of life. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients must be/have: 1. Female aged 15 years and over, with at least a 12 month documented history of experiencing MRM headache, according to IHS classification 2. Classified as ‘difficult to treat’ (see Section 5.4 and Appendix IX of the protocol) 3. Provided adequate diary data during the run-in phase to confirm diagnosis of MRM headache 4. At least 2 MRM headaches in the previous 3 months 5. Regular predictable menstrual periods 6. MRM headaches occurring between Day –2 and Day +3 of menses 7. Able and willing to sign informed consent and to comply with study procedures, including collection and reporting of diary data |
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E.4 | Principal exclusion criteria |
Patients must not be/have: 1. More than three migraine attacks per month that are not MRM attacks 2. 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 3. Significant cerebrovascular disease including basilar or hemiplegic migraine 4. Uncontrolled hypertension SBP > 180 mmHg, DBP > 95 mmHg 5. Severe hepatic or renal insufficiency 6. More than 15 headache days per month 7. Any other condition or serious illness which, in the opinion of the investigator, would interfere with optimal participation in the study 8. A history of clinically relevant allergy, including that to frovatriptan or other triptans 9. Pregnant or breast feeding, or intending to become pregnant or breast-feed during the study period (patients must be using adequate contraception and have a negative pregnancy test at screening) 10. Participated in clinical study VML 251/00/02 (frovatriptan in the prevention of menstrually-related migraine) or VML 251-3MAM03 (open label safety study of frovatriptan in the prevention of menstrually-related migraine. 11. Had treatment with another investigational drug within 30 days or 5 half lives (whichever is longer) before the screening visit 12. Had any change in their oral contraceptive medication (if applicable) in the 2 months prior to screening, or anticipate any change during study participation 13. Had any change in the type or dose of any prophylactic migraine medication in the 2 months prior to screening or anticipate any change during study participation. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of MRM headache free PMPs out of a potential of three treated PMPs |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Single blind placebo running, double blind parallel placebo controlled with an open label extension |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |