Ambulant male and non pregnant females aged 18 and 65 years with history of migraine according to the IHS criteria, having had at least one but not more than six episodes of migraine per month during the last 6 months, are eligible for enrolment in the study after having issued a written informed consent. MedDRA version: 6.1 Level: PT Classification code 10027599
Conditions
Interventions
Trade Name: AURADOL
Product Name: frovatriptan
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Frovatriptan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
LUSOFARMACO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is the evaluation of the existence and strength of the patient?s preference for either treatment medication.;Secondary Objective: The secondary objectives of this study include the evaluation of possible explanatory factors that may justify the results observed on the primary objective.;Primary end point(s): 1.The primary objective of this study is the evaluation of the existence and strength of the patient?s preference for either treatment medication. | — |
Countries
Italy
Outcome results
None listed