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Migraine HeadachePhase 3NCT02706015

Cefaliv® Compared to Neosaldina® in the Treatment of Migraine Attacks

A Phase 3 study of Migraine Headache, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study evaluates the non-inferiority of Cefaliv® compared to Neosaldina® in the treatment of migraine attack in two hundred and sixteen adults of both sexes with age between eighteen and sixty five years old. The first Half of participants will receive Cefaliv®, the other half will receive Neosaldina®. Read more about this study

Who is it for?
Ages 18 to 66 years
Conditions the study is for
Migraine Headache
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteBrazil
Study dates
Oct 2020to Jul 2021
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 66 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects of both sexes;
  • Age older or equal to 18 and younger than 66 years if they have symptoms of migraine headache before 50 years of age;
  • Presence of migraine headache with or without aura symptoms, at least 03 months prior to the study, the criteria defined by International Classification of Headache Disorders(ICHD)-II, 2004 International Headache Society(IHS) - Annex I;
  • Subjects which are experiencing 2-6 migraine attacks per month with mild to moderate pain intensity in the last 3 months prior to screening visit;
  • Subjects which are able to distinguish migraine attacks to any other type of headache;
  • Aptitude to understand and consent to participate in this clinical study, manifested by signing the Informed Consent and Informed (IFC);

Who cannot join

  • Any clinical finding (clinical evaluation / physical) that is interpreted by the Investigator as a risk to the participant in the clinical trial;
  • Subjects which had recent episodes of headache, with frequency equal or higher than 15 daily episodes per month, 3 months prior to the screening visit;
  • Subjects with headache history defined by the ICHD-II criteria, 2004 IHS (International Headache Society) rated as:
  • Typical aura with non-migraine headache;
  • Typical aura without headache;
  • Familial Hemiplegic Migraine (FHM);
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  • Sporadic Hemiplegic Migraine;
  • Basilar type Migraine;
  • Any laboratorial finding that the Investigator consider a risk to the subject of the study;
  • Hypersensitivity to the drug components, during the study;
  • Women in pregnancy or nursing period;
  • Women in reproductive age who do not agree to use contraception acceptable [oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation]; other than surgically sterile (bilateral oophorectomy or hysterectomy), postmenopausal for at least one (01) years or sexual abstinence;
  • Inability to understand and answer to the functional categorical scale of the study, diary of symptoms, and not having accompanying to assist him/her;
  • History of abuse, according to the principal investigator, of the alcohol, opioids, barbiturates, benzodiazepines and illicit drugs in the last 02 years, or abuse of drugs for headache including ergotamines or narcotics in the last 03 months;
  • Subjects with prolonged hypotension, shock, sepsis, pheochromocytoma, hemorrhage, mechanical obstruction or perforation of the gastrointestinal tract;
  • Subjects with history of epilepsy or presence of psychiatric illness of any kind, in the opinion of the investigator, that may interfere with adherence to treatment;
  • Subjects with a malignant disease less than five years, or for more than five years, but without documentation about the remission/cure. As example: melanoma, leukemia, lymphoma, myeloproliferative diseases and renal cell carcinoma of any length should be excluded. Exceptions: Subjects with basal cell skin cancers, squamous cell, and cervical cancer in situ may be eligible.
  • Subjects which uses a preventive treatment and changed the dose in the last 3 months before the screening visit (V0);
  • Subjects who have made an interruption in the prophylactic treatment, in the last 30 days prior to screening visit (V0);
  • Subjects with hepatic or renal failure;
  • Subjects in the research that has participated in clinical trial protocols in the last twelve (12) months (National Board of Health- Resolution 251 of 07 August 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to it;
  • Subjects who are in prohibited medication as described in item 10.2 of the Protocol.
  • Subjects with previous diagnosis of uncontrolled hypertension;
  • Subjects with history of peripheral vascular disease; acute myocardial infarction, angina pectoris and other ischemic heart disease;
  • Subjects who have allergy to pyrazolones (eg phenazone, propyphenazone) or pyrazolidines (eg phenylbutazone,oxyphenbutazone) or who have submitted agranulocytosis in relation to any of these medicines;
  • Subjects with history of metabolic disorders such as porphyria and congenital deficiency of glucose-6-phosphate dehydrogenase;
  • Subjects with history of alteration in the bone marrow function or hematopoietic system diseases;
  • Subjects with history of bronchospasm or other allergic reactions (rhinitis, urticaria, angioedema) induced by aspirin, acetaminophen, or other anti-inflammatory medications.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Ache Laboratorios Farmaceuticos

    Guarulhos, São Paulo

Other trials in Brazil

About this study

Official title: National, Phase III, Multicenter, Randomized, Double-Blind, Parallel, Non-Inferiority Trial to Evaluate the Efficacy and Safety of Cefaliv® Compared to the Neosaldina® in the Treatment of Migraine Attacks

This study evaluates the non-inferiority of Cefaliv® compared to Neosaldina® in the treatment of migraine attack in two hundred and sixteen adults of both sexes with age between eighteen and sixty five years old. The first Half of participants will receive Cefaliv®, the other half will receive Neosaldina®.

Read the detailed description

Cefaliv® is a combination of 3 drugs: dihydroergotamine mesylate, dipyrone sodium, and caffeine. The dihydroergotamine mesylate interacts with the serotonergic, dopaminergic and noradrenergic receptors, but it's mechanism is not totally known. The dipyrone is a non-steroidal antiinflammatory which has an analgesic, antiinflammatory and antipyretic effect. And the caffeine presents mechanisms that are not totally clear, but it may relieves the pain by activating of the central noradenosine pathway (pain suppressing system).

Being tested
Cefaliv® & Placebo, Neosaldina® & Placebo
Keywords
Headache, Aura, Migraine
Medical subject headings
Migraine Disorders, Headache, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cefaliv® & PlaceboDrug

    Also called Cefaliv® (Dihydroergotamine mesylate+ dipyrone sodium + caffeine) & Placebo

    02 tablet of Cefaliv® + 02 tablet of comparator placebo, VO, after the beging of migraine with with mild to moderate pain

  • Neosaldina® & PlaceboDrug

    Also called Neosaldina® (Isometheptene mucate + dipyrone sodium + anhydrous caffeine) & Placebo

    02 tablets of Neosaldina® + 02 tablet of comparator placebo, VO, after the beging of migraine with with mild to moderate pain

Study groups in NCT02706015
Study groupRoleWhat they receive
Cefaliv® & PlaceboExperimentalDihydroergotamine mesylate+ dipyrone sodium + caffeine
Receives: Drug: Cefaliv® & Placebo
Neosaldina® & PlaceboActive comparatorIsometheptene mucate + dipyrone sodium + anhydrous caffeine
Receives: Drug: Neosaldina® & Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the efficacy and non-inferiority of Cefaliv® compared to Neosaldina® in pain relief

    The evaluation will be measured by the absolute variation of VAS (0 mm no pain - 100 mm pain as bad as can be) 2 hours after taking the medication, without taking any rescue medication.

    Measured: 2 Hours

Secondary outcomes (5)

  1. The remission of the pain after use of the investigational product, without use of a rescue medication;

    Proportion of participants with pain remission in 2 hours and 4 hours after the use of the investigational product, in the first migraine attack with mild or moderate pain, with remission defined as no pain (0) in categorical scale debilitating functional and behavioral (4 point-scale), without use of a rescue medication;

    Measured: 2 and 4 hours after taking the medication

  2. The relief of pain after use of the investigational product, without use of a rescue medication;

    Proportion of participants with pain relief in 2 hours and 4 hours after the use of the investigational product, in the first migraine attack with mild or moderate pain,and is considered the relief reduction of at least 01 point in pain intensity from baseline, according to functional and behavioral debilitating categorical scale without use of a rescue medication;

    Measured: 2 and 4 hours after taking the medication

  3. Proportion of participants with pain relief maintenance during the period 4-24 hours after use of the investigational product, the first migraine attack with mild or moderate pain

    The maintenance will be observed if the relief reached the first 4 hours will remain at 24 hours after use of the investigational product, according to functional and behavioral debilitating categorical scale (4 point scale) without use of a rescue medication during this period;

    Measured: 4 to 24 hours after taking the medication

  4. Need for use of a rescue medication.

    Proportion of participants who use at least once a rescue medication in the period 2-24 hours after use of the investigational product.

    Measured: 2 to 24 hours after taking the experimental drug

  5. The proportion of subjects with no symptoms of Nausea / vomiting and photophobia / phonophobia

    Free of photophobia, phonophobia, nausea and vomiting response rate symptoms 2 and 4 hours after use of the investigational product, the first with migraine pain of mild to moderate intensity, defined as the proportion of subjects with no symptoms of both among the participants have at least one symptom at baseline of migraine without use of a rescue medication during this period.

    Measured: 2 to 4 hours after taking the medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2016 (estimated)
  2. Study startOct 2020 (estimated)
  3. Primary completionMay 2021 (estimated)
  4. Study completionJul 2021 (estimated)

Why it stopped: Strategic reasons of the company

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02706015
Sponsor's protocol ID
ACH-CFL-03(10/14)
Status last verified
Apr 2019
First submitted
23 Nov 2015
Last updated
10 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Migraine Headache, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.

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 6 inclusion and 28 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 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Evaluate the efficacy and non-inferiority of Cefaliv® compared to Neosaldina® in pain relief (time frame: 2 Hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02706015.

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 10 Apr 2019.

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