acute migraine MedDRA version: 6.1 Level: PT Classification code 10027599
Conditions
Interventions
Trade Name: RILAMIG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Frovatriptan
Current Sponsor code: Gui/06/Fro-pp/002
Concentration unit: µg microgram(s)
Concentration type: equal
Concentr
Sponsors
GUIDOTTI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: consenting ambulant male or non-pregnant female patients between >=18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: history suggestive of ischaemic heart disease or any atherosclerotic disease indicating an increased risk of coronary ischaemia; ? symptomatic Wolff-Parkinson-White syndrome or cardiac arrhythmias associated with other cardiac accessory conduction pathway disorders; ? history of stroke or transient ischaemic attack (TIA); ? uncontrolled hypertension; ? history of basilar, hemiplegic or ophthalmoplegic migraine; ? severe liver impairment (i.e., Child-Pugh score >=7); ? severe renal impairment (i.e., CrCl <26 ml/min), renal disease, or renal failure; ? 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); ? use of either test medication to treat any one of the last three episodes of migraine; ? history of intolerance or inefficacy of at least two triptans for the treatment of migraine attacks; ? current use of propranolol or ergotamine or its derivatives; ? current use or use within the last 2 weeks of MAO-inhibitors; ? abuse of alcohol, analgesics or psychotropic drugs; ? severe concurrent medical condition that may affect the interpretation of clinical trial results; ? pregnancy or breastfeeding; ? participation in a clinical trial, currently or within the previous month; ? inability or refusal to issue the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;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. | — |
Countries
Italy
Outcome results
None listed