MigrainePhase 3CopérnicoNCT01726920
Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine.
A Phase 3 study testing naratriptan + naproxen, naratriptan and naproxen in people with Migraine and Headache, run by Ache Laboratorios Farmaceuticos S.A..
Trial summary
The purpose of this study is to determine whether a fixed-dose combination of naratriptan 2,5 mg + naproxen 500 mg is effective and safe compared each monotherapy for the acute treatment of migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- naratriptan + naproxen, naratriptan and naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 doesn't use, or doesn't agree 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;
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- Patients in acupuncture treatment for the symptoms of migraine attacks;
- History or symptoms of cardiovascular disease (myocardial infarction, ischemic heart disease, or with Prinzmetal's angina) or has symptoms of ischemic heart disease;
- Suffers from peripheral vascular 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 or ergotamines headache in the past 03 months;
- Hypersensitivity to naratriptan, naproxen, or any of its components;
- Hypersensitivity to 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.
About this study
Official title: A Phase III, Multicenter, National, Open, Randomized, Parallel and Comparative Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Naratriptan 2,5 mg + Naproxen 500 mg for the Acute Treatment of Migraine.
The purpose of this study is to determine whether a fixed-dose combination of naratriptan 2,5 mg + naproxen 500 mg is effective and safe compared each monotherapy for the acute treatment of migraine.
- Being tested
- naratriptan + naproxen, naratriptan, naproxen
- Keywords
- Migraine, Naratriptan, Naproxen
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naratriptan + naproxenDrug
Tablets containing naratriptan 2,5 mg + naproxen 500 mg
naratriptanDrug
Tablets containing naratriptan 2,5 mg
naproxenDrug
Tablets containing naproxen 500 mg
| Study group | Role | What they receive |
|---|---|---|
| naratriptan + naproxen | Experimental | Fixed-dose combination of naratriptan + naproxen Receives: Drug: naratriptan + naproxen |
| naratriptan | Active comparator | Not described Receives: Drug: naratriptan |
| naproxen | Active comparator | Not described Receives: Drug: naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours after single dose treatment
Secondary outcomes (9)
Headache relief 4 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
Measured: 4 hours after single dose treatment
Maintenance of pain relief between 2 and 24 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.
Measured: 2 to 24 hours after single dose treatment
Pain-free response 2 and 4 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.
Measured: 2 and 4 hours after single dose treatment
Maintenance of pain-free response between 2 and 24 hours, 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.
Measured: 2 to 24 hours after single dose treatment
Freedom from nausea, vomiting, photophobia and phonophobia 2 and 4 hours after dosing
Participants were evaluated (self-assessment) for the presence of vomiting, nausea, photophobia and phonophobia.
Measured: 2 and 4 hours after single dose treatment
Maintenance of freedom from nausea, vomiting, photophobia and phonophobia between 2 and 24 hours after dosing, without use of rescue medication
Participants were evaluated (self-assessment) for the presence of vomiting, nausea, photophobia and phonophobia.
Measured: 2 to 24 hours after single dose treatment
Recurrence of pain between 2 and 24 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.
Measured: 2 to 24 hours after single dose treatment
Proportion of subjects who used rescue medication between 2 and 24 hours after dosing, at least once
Participants were evaluated (self-assessment) about use of rescue medication.
Measured: 2 to 24 hours after single dose treatment
Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
Measured: Collection of safety data throughout the whole study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startJul 2014
- Primary completionDec 2014 (estimated)
Why it stopped: Due to budget limitations, the company decided to withdraw this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726920
- Sponsor's protocol ID
- ACH-NRP-03(04/12)
- Acronym
- Copérnico
- Status last verified
- Mar 2016
- First submitted
- 12 Nov 2012
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, National, Open, Randomized, Parallel and Comparative Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Naratriptan 2,5 mg + Naproxen 500 mg for the Acute Treatment of Migraine.
- ClinicalTrials.gov ID
- NCT01726920
- Acronym / sponsor ID
- Copérnico / ACH-NRP-03(04/12)
- Keywords
- Migraine, Naratriptan, Naproxen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to budget limitations, the company decided to withdraw this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (estimated)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a fixed-dose combination of naratriptan 2,5 mg + naproxen 500 mg is effective and safe compared each monotherapy for the acute treatment of migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| naratriptan + naproxen | Experimental | Drug: naratriptan + naproxenFixed-dose combination of naratriptan + naproxen |
| naratriptan | Active comparator | Drug: naratriptan |
| naproxen | Active comparator | Drug: naproxen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (22 listed)
- 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 doesn't use, or doesn't agree 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naratriptan + naproxenTablets containing naratriptan 2,5 mg + naproxen 500 mg | Drug | naratriptan + naproxen |
| naratriptanTablets containing naratriptan 2,5 mg | Drug | naratriptan |
| naproxenTablets containing naproxen 500 mg | Drug | naproxen |
Primary outcome
Headache relief 2 hours after dosing, without use of rescue medication
Time frame: 2 hours after single dose treatment
Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0= none, 1= mild, 2= moderate, and 3= severe.
9 secondary outcomes
Headache relief 4 hours after dosing, without use of rescue medication
Time frame: 4 hours after single dose treatment
Maintenance of pain relief between 2 and 24 hours after dosing, without use of rescue medication
Time frame: 2 to 24 hours after single dose treatment
Pain-free response 2 and 4 hours after dosing, without use of rescue medication
Time frame: 2 and 4 hours after single dose treatment
Maintenance of pain-free response between 2 and 24 hours, without use of rescue medication
Time frame: 2 to 24 hours after single dose treatment
Freedom from nausea, vomiting, photophobia and phonophobia 2 and 4 hours after dosing
Time frame: 2 and 4 hours after single dose treatment
Maintenance of freedom from nausea, vomiting, photophobia and phonophobia between 2 and 24 hours after dosing, without use of rescue medication
Time frame: 2 to 24 hours after single dose treatment
Recurrence of pain between 2 and 24 hours after dosing, without use of rescue medication
Time frame: 2 to 24 hours after single dose treatment
Proportion of subjects who used rescue medication between 2 and 24 hours after dosing, at least once
Time frame: 2 to 24 hours after single dose treatment
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing naratriptan + naproxen, naratriptan and naproxen in people with Migraine and Headache, run by Ache Laboratorios Farmaceuticos S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache relief 2 hours after dosing, without use of rescue medication (time frame: 2 hours after single dose treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.