EFFICACY AND TOLERABILITY OF NIMESULIDE FOR THE TREATMENT OF MIGRAINE TTACKS: A RANDOMISED, MULTICOUNTRY, DOUBLE BLIND, PLACEBO CONTROLLED, CROSS-OVER TRIA

• Registration Number: EUCTR2005-000583-28-AT
• Lead Sponsor: HELSINN HEALTHCARE SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-29
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

•Adult males and females out-patients aged > 18 to < 65 years;
•Migraine with and / or without aura for more than 1 year following the ICHD II ( The International Classification of the Headache Disorders 2004 ) ( Appendix no. 3 )
•Frequency of attacks of more than one but less than 6 attacks per month ( in any case less than fifteen headache days per month );
•Age at migraine onset < 50 years;
•Ability to differentiate headache attacks that are not migraine from the very beginning of the attack;
•Physical examination results, including vital signs within the reference ranges or clinically acceptable to the Investigator;
•Able and willing to give written informed consent;

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

•Patients with more than one out of three attacks on waking;
•Patients with known hypersensitivity to nimesulide or to any of the excipients of the products;
•Presence or intention of pregnancy and breast feeding;
•Patients with hepatic impairment;
•Severe renal impairment or severe heart failure;
•Patients with abnormal routine laboratory biochemistry parameters (especially SGOT, GPT, ?GT and bilirubin) at screening.
•Patients with metabolic or other diseases like malignancy and major psychiatric disorders that, in the view of the investigator, could compromise the patient’s participation in the study;
•Patients with history of hypersensitivity reactions (i.e.: bronchospasm, rhinitis, urticaria) in response to acetylsalicylic acid or other non steroidal anti-inflammatory drugs.
•Patients with obstructive pulmonary disease;
•Concurrent treatment with glucocorticoids (unless given as supplements);
•Patients with active gastric or duodenal ulcer, a history of recurrence ulceration or gastrointestinal bleeding, cerebrovascolar bleeding or other active bleeding or bleeding disorders;
•Patients with severe coagulation disorders;
•Patients taking drugs during the previous three months in doses likely to produce amnesia during the study period (e.g. benzodiazepines, psychotropic and major tranquillisers);
•Treatments with oral contraceptive or prophylactic medication for migraine if taken for less than 2 months before the study start and/or modified during the trial;
•Patients with known contraindication to nimesulide or to any of the excipients of the products;
•Patients with known hepatotoxicity reaction in response to nimesulide;
•Patients using nimesulide or other NSAIDs and/or ASA on a daily basis;
•Patients who abuse of alcohol or other drugs;
•Patients who are treated with hepatotoxic drugs;
•Patients who have used any investigational drug and/or participated in any clinical trial within 3 months of entry to this study;
•Patients unable to give a valid informed consent or unable to properly follow the protocol.
•Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified