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. MedDRA version: 9.1 Level: LLT Classification code 10027599 Term: Migraine
Conditions
Interventions
Trade Name: AURADOL
Pharmaceutical Form: Capsule, hard
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Trade Name: ZOMIG
Pharmaceutical Form: Capsule, hard
Co
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. chronic cephalea; 7. severe liver impairment i.e., Child-Pugh 8805;7 ; 8. severe renal impairment i.e., CrCl 26 ml/min , renal disease, or renal failure; 9. 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 ; 10. use of either test medication in the last month; 11. history of intolerance or inefficacy of at least two different triptans taken in a correct way for the treatment of migraine attacks; 12. current use of ergotamine or its derivatives as a prophylactic agent; 13. current use or use within the last 2 weeks of MAO-inhibitors; 14. use as a prophylactic agent of amitriptilina with dose 25 mg/die; 15. abuse of alcohol, analgesics or psychotropic drugs; 16. any severe concurrent medical condition that, according to the site Investigator, may affect the interpretation of clinical trial results; 17. pregnancy or breastfeeding; females or childbearing potential not using an effective form of contraception; 18. participation in a clinical trial, currently or within the previous month; 19. inability or unwillingness to issue the informed consen.
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): 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