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Migraine | Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine

Migraine research study

What is the primary objective of this study?

The purpose of this study is to determine whether a fixed-dose combination of naratriptan + naproxen is effective compared each monotherapy for the acute treatment of migraine.

Who is eligible to participate?

Inclusion Criteria: - Male or female patient, age in the range of 18-65 years inclusive that has onset of migraine before age 50; - Patient has at least a 3-month history of migraine with or without aura according to the ICHD-II, 2004, IHS (International Headache Society) criteria; - Patients experienced an average migraine headache frequency of 2-6 moderate or severe attacks per month in the last 03 months prior to screening visit; - Patients able to distinguish his/her migraine attacks from any other types of headaches; - Patients able to understand and consent to participate in this clinical study, expressed by signing the Informed Consent (IC). Exclusion Criteria: - History of more than 6 migraine attacks/month in the last 03 months prior to screening visit; - History of non-migraine headache frequency ≥ 15 days/month in each of the 3 months prior to screening. - History of following migraine variants, according to the ICHD-II, 2004, IHS (International Headache Society): basilar migraine, aura without headache, familial hemiplegic migraine, sporadic hemiplegic migraine or aura with non-migraine headache; - If female of childbearing potential, has a negative urine pregnancy test at Visit 0 and uses, or agrees to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator; - Woman in pregnancy or lactation period; - History of epilepsy or psychiatric condition that may affect the compliance of the treatment; - Patients in acupuncture treatment for the symptoms of migraine attacks; - Suffers from cardiovascular disease (ischemic heart disease, including angina pectoris, myocardial infarction, documented silent ischemia, or with Prinzmetal's angina) or has symptoms of ischemic heart disease; - History of cerebrovascular pathology including stroke and/or transient ischemic attacks; - History of allergic reactions to naproxen preparations, including subjects in whom aspirin or other NSAID drugs induce the syndrome of asthma, rhinitis, nasal polyps or urticaria; - Diagnosis of renal or hepatic failure; - Has significant (as determined by the investigator) cardiovascular risk factors that may include uncontrolled high blood pressure, post-menopausal women, males over 40 years old, hypercholesterolemia, obesity, diabetes mellitus, smoking, or a family history of cardiovascular disease in a 1st degree relative. - Patients who have stopped or changed the dosage of the preventive treatment of migraine in the last 2 weeks prior the screening visit (V0), including the use of calcium channel blockers, tricyclic antidepressants, beta blockers or serotonergic medications for any other indications; - Use of prohibited medicine as shown in 9.3 item of this protocol; - Inability to understand and report the categorical scale debilitating functional of study or symptoms diary; - Has abused, in the opinion of the Investigator, any of the following drugs, currently or within the past 2 years: opioids, alcohol, barbiturates, benzodiazepine, cocaine or abuse of drugs for migraine treatment including narcotics ergotamines headache in the past 03 months; - Hypersensitivity, intolerance, or contraindication to the use of naratriptan or naproxen, any of its components; - Hypersensitivity, intolerance, or contraindication to the use of sulfonamides; - History of malignancy ≤ 5 years or > 5 years without documentation of remission / cure, for example, melanoma, leukemia, lymphoma, myeloproliferative disorders and renal cell carcinoma of any duration. Exception: Subjects with basal cell skin cancers, squamous cell, and cervical cancer in situ may be eligible; - Participation in last one year of clinical protocols, unless it can be direct benefit to patient; - Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the patient or interfere with the endpoints of study.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Migraine

Headache

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Fixed-dose combination of naratriptan+naproxenTablets containing naratriptan 2,5 mg + naproxen 500 mg

Drug:NaratriptanTablets containing naratriptan 2,5 mg

Drug:NaproxenTablets containing naproxen 500 mg

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Fixed-dose combination of naratriptan+naproxenFixed-dose combination of naratriptan+naproxen

NaratriptanNaratriptan

NaproxenNaproxen

Study Status

Withdrawn

Start Date: December 2011

Completed Date: March 2012

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Headache relief 2 hours after dosing, without use of rescue medication.

Secondary Outcome: Headache relief 4 hours after dosing, without use of rescue medication

Study sponsors, principal investigator, and references

Principal Investigator: Deusvenir S Carvalho

Lead Sponsor: Ache Laboratorios Farmaceuticos S.A.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01390324

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