E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Migraine with or without aura according to the IHS criteria |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027599 |
E.1.2 | Term | Migraine |
|
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 this study is to evaluate the subjective patient’s preference for either study medication after having tested both of them on a number of between 1 and 3 attacks of migraine in a maximum period of 3 months. This will be evaluated independently in the two sequence subgroups. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to evaluate, in the same target population, the reasons indicated by the patient to explain the expressed preference, the proportion of episodes rated as painless at 2 hours and 4 hours, the changes of migraine intensity in 4 hours, the proportion of episodes requiring the second drug dose/rescue medication, the proportion of recurring episodes and the time to recurrence. Clinical safety (adverse events, vital signs) will also be monitored prestudy and at the end of each treatment period. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A subject is eligible for inclusion in this study only if all of the following criteria apply: 1. ambulant male and non pregnant female subjects; 2. ≥18 and ≤65 years of age at the randomisation visit; 3. with a current history of migraine with or without aura according to the IHS criteria; 4. having experienced an average of at least one but not more than six migraine attacks per month for 6 months prior to entry into the study; 5. willing and able to understand and complete the anticipated study questionnaires; 6. willing and able to sign the informed consent prior to entry into the study. |
|
E.4 | Principal exclusion criteria |
Subjects will not be eligible for inclusion in this study if any of the following conditions apply: 1. history suggestive of ischaemic heart disease (IHD; e.g. myocardial infarction, angina pectoris, coronary vasospasm, vasospastic [Prinzmetal’s variant] angina) or any atherosclerotic disease (e.g. peripheral vascular disease) indicating an increased risk of coronary ischaemia; 2. symptomatic Wolff-Parkinson-White syndrome or cardiac arrhythmias associated with other cardiac accessory conduction pathway disorders; 3. history of stroke or transient ischaemic attack (TIA); 4. uncontrolled hypertension; 5. history of basilar, hemiplegic or ophthalmoplegic migraine; 6. severe liver impairment (i.e., Child-Pugh C); 7. severe renal impairment (i.e., CrCl <26 ml/min), renal disease, or renal failure; 8. known or suspected intolerance of, or hypersensitivity or contraindications to any component of the trial medications, including inert substances (e.g. intolerance to galactose, Lapp’s lactase deficiency, malabsorption of glucose-galactose, phenylketonuria); 9. use of either test medication to treat any one of the last three episodes of migraine; 10. history of intolerance or inefficacy of at least two triptans for the treatment of migraine attacks; 11. current use of propranolol or ergotamine (or its derivatives) as a prophylactic agent; 12. current use or use within the last 2 weeks of MAO-inhibitors; 13. abuse of alcohol, analgesics or psychotropic drugs; 14. any severe concurrent medical condition that, according to the site Investigator, may affect the interpretation of clinical trial results; 15. pregnancy or breastfeeding; 16. participation in a clinical trial within the previous month or current participation in any other clinical research study or clinical trial; 17. inability or unwillingness to issue the informed consent 18. more than six days of tension-type headache |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the preference expressed by the patient on a visual analogue scale for the first or second treatment received. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
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 | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
evaluation of patient´s preference for either study medication |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
| |
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |