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Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine (Atenéia)

Primary Purpose

Migraine, Headache

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Fixed-dose combination of naratriptan+naproxen
Naratriptan
Naproxen
Sponsored by
Ache Laboratorios Farmaceuticos S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Naratriptan, Naproxen

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Fixed-dose combination of naratriptan+naproxen

    Naratriptan

    Naproxen

    Arm Description

    Fixed-dose combination of naratriptan+naproxen

    Naratriptan

    Naproxen

    Outcomes

    Primary Outcome Measures

    Headache relief 2 hours after dosing, without use of rescue medication.
    Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.

    Secondary Outcome Measures

    Headache relief 4 hours after dosing, without use of rescue medication
    Sustained headache relief over 24 hours, without use of rescue medication
    Pain-free response 2 and 4 hours after dosing, without use of rescue medication
    Sustained pain-free response over 24 hours, without use of rescue medication
    Freedom from photophobia, phonophobia and nausea 2 and 4 hours after dosing, without use of rescue medication
    Sustained freedom from photophobia, phonophobia and nausea from 2 through 24 hours after dosing, without use of rescue medication
    Proportion of subjects who used rescue medication between 2 and 24 hours after dosing, at least once
    Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.

    Full Information

    First Posted
    July 7, 2011
    Last Updated
    October 18, 2016
    Sponsor
    Ache Laboratorios Farmaceuticos S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01390324
    Brief Title
    Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine
    Acronym
    Atenéia
    Official Title
    A Multicenter, National, Double-blind, Randomized Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Naratriptan 2,5 mg + Naproxen 500 mg Relative to Efficacy and Safety of Each Monotherapy for the Acute Treatment of Migraine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ache Laboratorios Farmaceuticos S.A.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine, Headache
    Keywords
    Migraine, Naratriptan, Naproxen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fixed-dose combination of naratriptan+naproxen
    Arm Type
    Experimental
    Arm Description
    Fixed-dose combination of naratriptan+naproxen
    Arm Title
    Naratriptan
    Arm Type
    Active Comparator
    Arm Description
    Naratriptan
    Arm Title
    Naproxen
    Arm Type
    Active Comparator
    Arm Description
    Naproxen
    Intervention Type
    Drug
    Intervention Name(s)
    Fixed-dose combination of naratriptan+naproxen
    Intervention Description
    Tablets containing naratriptan 2,5 mg + naproxen 500 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Naratriptan
    Intervention Description
    Tablets containing naratriptan 2,5 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Naproxen
    Intervention Description
    Tablets containing naproxen 500 mg
    Primary Outcome Measure Information:
    Title
    Headache relief 2 hours after dosing, without use of rescue medication.
    Description
    Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.
    Time Frame
    2 hours after single dose of double-blind treatment
    Secondary Outcome Measure Information:
    Title
    Headache relief 4 hours after dosing, without use of rescue medication
    Time Frame
    4 hours after single dose of double-blind treatment
    Title
    Sustained headache relief over 24 hours, without use of rescue medication
    Time Frame
    24 hours after single dose of double-blind treatment
    Title
    Pain-free response 2 and 4 hours after dosing, without use of rescue medication
    Time Frame
    2 and 4 hours after single dose of double-blind treatment
    Title
    Sustained pain-free response over 24 hours, without use of rescue medication
    Time Frame
    24 hours after single dose of double-blind treatment
    Title
    Freedom from photophobia, phonophobia and nausea 2 and 4 hours after dosing, without use of rescue medication
    Time Frame
    2 and 4 hours after single dose of double-blind treatment
    Title
    Sustained freedom from photophobia, phonophobia and nausea from 2 through 24 hours after dosing, without use of rescue medication
    Time Frame
    2 through 24 hours after single dose of double-blind treatment
    Title
    Proportion of subjects who used rescue medication between 2 and 24 hours after dosing, at least once
    Time Frame
    2 and 24 hours after single dose of double-blind treatment
    Title
    Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
    Time Frame
    Collection of safety data throughout the whole study period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deusvenir S Carvalho
    Organizational Affiliation
    Federal University of São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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