Migraine with or without aura according to the IHS criteria MedDRA version: 8.1 Level: LLT Classification code 10027599 Term: Migraine
Conditions
Interventions
Trade Name: Migard
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Frovatriptan
CAS Number: 158747-02-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-
Sponsors
Menarini International Operations Luxembourg S.A., Avenue de la Gare, 1611 Luxembourg, Luxembourg
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the subjective existence and strength of the 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. ;Secondary Objective: 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 pre-study and at the end of each treatment period. ;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. The secondary endpoints are: • the patient’s preference questionnaire; • the intensity of migraine, in particular at 2 h and 4 h after dosing, evaluated as: sum of intensity change from pre-dosing value, episodes with intensity=”nil” at 2 hours, episodes with intensity=”nil” at 4 hours; • the use of a second dose of medication or of rescue medication to treat the migraine episode (processed as proportion of episodes and as proportion of patients using this procedure at least once); • recurrence (another episode of migraine occurring within 48 hours from dosing, with a definite pain-free interval in between), to be processed as proportion of recurring episodes and as time to recurrence; • proportion of sustained pain-free episodes, defined as migraine attacks pain-free at two hour, not requiring the use of rescue medication and not recurring within 48 hours; • degree of patient’s satisfaction after 48 hours; • proportion | — |
Countries
Denmark, Ireland, Portugal, Spain
Outcome results
None listed