migraine with or without aura MedDRA version: 9.1 Level: SOC Classification code 10029205 MedDRA version: 9.1 Level: PT Classification code 10027599
Conditions
Interventions
Trade Name: AURADOL
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Frovatriptan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Trade Name: AURA
Sponsors
LUSOFARMACO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female subjects between 18-65 years of age - Subjects signing their Informed Consent at V-1 - Diagnosis of migraine with or without aura, meeting the criteria issued by the International Headache Society in 2001, published in 2003 - Frequency of 1 to 6 migraine attacks per month for at least 6 months prior to start of the study - Women of childbearing age must have a negative pregnancy test before inclusion in the study and they must use adequate contraceptive protection for all study duration (from the moment they sign their informed consent at V-1, until the end of the follow-up period). 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: - Diagnosis of typical aura with non-migraine headache, typical aura without headache, basilar migraine, hemiplegic migraine, opthalmoplegic migraine. - Coexistence of other headache types, in addition to migraine with aura or migraine without aura. - History of drug abuse in acute migraine attacks treatment (subjects taking drugs to treat acute migraine attacks for 10 or more days a month). - Use of prophylactic migraine attacks therapy in case dose has not been stable for at least three months before V0 (in case of stable dose, it must remain the same for all study duration). - Subjects that have taken antipsychotics or antidepressant drugs (unless they were taken as prophylaxis of migraine attacks) within the three months prior to V0. - Subjects that received anti-psychotic medication. - Subject taking ergotamine, ergotamine-derived (including methysergide), St John?s Wort (Hypericum perforatum), monoamine-oxidase inhibitors, NSAIDs (COX-2 inhibitors), oral corticosteroid, warfarin or other coumarins, Selective serotonin reuptake inhibitors, antiaggregant agents such as aspirin, heparin, lithium, methotrexate, idantoine and sulphonamides. - Subjects who meet DSM-IV criteria for alcohol/drug abuse or dependence. - Subjects allergic to IMP or similar drugs or with hypersensitivity to any ingredient of the trial drug composition. - Subjects with anamnesis of myocardial infarction, ischemic heart disease, coronary vasospasm, peripheral vascular disease, signs or symptoms suggesting ischemic heart disease. - Severe or moderately severe hypertension, or non controlled mild hypertension. - Previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA). - Risk of coronary disease, including hard smokers or subjects following a nicotine substitute treatment, without a preliminary cardiovascular evaluation. - Subjects with familiar galactose intolerance, with lactase deficit or suffering from glucose-galactose malabsorption. - Liver pathology (AST or ALT >3 times greater than normal upper limit or total serum bilirubin >1.5 times greater than normal upper limit). - Renal insufficiency (serum creatinine >200 Omol/L or 2 mg/dL). - Subjects who have previously shown hypersensitivity reactions to NSAIDs (e.g., asthma, broncospasm, acute rhinitis, nasal polyp, urticaria, or angioneurotic edema). - Suspect or active peptic ulcer/bleeding or positive anamnesis for peptic ulcer/bleeding or chronic dyspepsia. - History of gastrointestinal bleeding or perforation related to NSAIDs therapies. - Subjects with gastrointestinal bleeding or other active bleeding, or blood coagulation diseases. - Crohn?s disease or ulcerous colitis. - Bronchial asthma. - Severe cardiac failure. - Bleeding diathesis or other coagulation disturbances. - Hemopoietic impairment, systemic lupus erythematosus or connective system pathologies. - Pregnancy or breast feeding. - Concurrent involvement in another investigational study or participation within 6 months prior to the start of this study (V0).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of treatments according to percentage of subjects pain-free at 2h, before any rescue medication.;Secondary Objective: To evaluate efficacy according to: percentage of subjects pain-free at 1h and 4h, before any rescue medication, sustained pain-free (percentage of subjects pain-free within 2h with no use of rescue medication or recurrence within 48h); percentage of subjects with a decrease in headache from severe or moderate to mild or none within 2h (headache relief); percentage of subjects with a decrease in headache from severe or moderate to mild or none at 1 hour, at 2 hours and at 4 hours; time to meaningful relief, defined subjectively by the subject; speed of onset of action evaluated by comparing pain intensity at 60, 90 120 and 240 min; percentage of subjects taking rescue medication; subjects? preference for treatments; percentage of subjects with resolution of nausea, vomiting, photophobia, phonophobia and osmophobia; incidence of recurrence: percentage of subjects pain-free within 2h after treatment and recurrence of headache within 48h from treatment. To evaluate safety of treatments;Primary end point(s): Primary endpoint will be the percentage of subjects pain-free at 2h, before any rescue medication. The assessment of possible superiority of frovatriptan plus dexketoprofen (high and low dose) versus frovatriptan alone will be based on the treatment group differences assuming a delta of 20% between frovatriptan plus dexketoprofen (high dose) and frovatriptan alone. | — |
Countries
Italy
Outcome results
None listed