Evaluation of the effectiveness and the tollerability of paracetamol 1000 mgs + caffeine 130 mgs in the treatment of the migraine. I study randomizzato, double blind, double dummy, vs. sumatriptan 50 mgs and placebo - ND

Conditions: Patients will be enlisted you cut from migraine with and without aura (codes 1.1 and 1.2.1, according to the criterions defined by the International Classification ICH2 of the 2004)
MedDRA version: 9.1Level: HLGTClassification code 10019231

Registration Number: EUCTR2010-019083-36-IT

Lead Sponsor: .O. Tossicologia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

males and females who come to our observation in outpatient access regime with a history of migraine of at least two years of age `of between 18 and 65 years, usually taking at least two cups of coffee` a day), women age ` fertile adopt an adequate system of contraception; average frequency of crises between two and fourteen episodes per month, duration of episodes of headache between 4 and 72 hours; diagnosis of migraine with and without aura, as defined by the presence of at least two of the following characteristics : unilateral pain or pain-type button; intensity or `mild to moderate headache or aggravated by normal activities` physics, such as walking or climbing stairs; detection of both characteristics: the presence of, or nausea or vomiting or photophobia and phonophobia, or osmofobia. headache not attributable to any other concomitant pathology, subjects could potentially also benefit from treatment with opioid analgesics not; availability `to sign the informed consent form.
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

hypersensitivity or allergy verified to the products in study; positive anamnesis for chronic cefalea, recurrent continuous e/o; cefalea postraumatica; positive anamnesis for cardiopatia ischemica, pregresso heart attack miocardico, my goodness cerebro-vascular or you attach transitory (TIA) ischemici, coronaropatia, peripheral vasculopatie, troubles pancreatici, meaningful liver and renal troubles clinically, arterial (I save the light forms and under pharmacological control) hypertension, fenilchetonuria, serious anemia emolitica; concomitant use and abuse of antiinfiammatori not steroidei and other analgesics; treatment with anticoagulants or medicines that inhibit the aggregation piastrinica; in treatment for psychiatric troubles or under the influence of alcohol or drugs; in treatment with experimental medicines in the preceding 4 weeks. presence of renal or liver insufficiency; presence of syndrome of Gilbert; pregnancy or nursing.