E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
migraine with or without aura |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029205 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027599 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate efficacy of treatments according to percentage of subjects pain-free at 2h, before any rescue medication. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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). |
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E.4 | Principal 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). |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 25 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 3 |