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MigrainePhase 3NCT02582996

Cefalium® Compared to Tylenol® in the Treatment of Migraine Attacks

A Phase 3 study testing Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide. and Acetaminophen in people with Migraine, run by Ache Laboratorios Farmaceuticos S.A. at 6 sites in Brazil.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

National clinical trials, phase III, randomized, open, parallel, study of superiority, in which three hundred thirty-six (336) participants of both sexes, aged between 18 and 65 years will be randomly allocated to one of two treatment groups. The Group 01 will use Cefalium® and group 02 will use Tylenol®. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine
What is being tested?
Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide. and Acetaminophen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
6 sitesBrazil
Study dates
Apr 2020to Jun 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects of both gender;
  • 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 (IHS International Headache Society) - 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;
  • Participants which are able to distinguish migraine attacks to any other type of headache;
  • Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF).

Who cannot join

  • Any clinical finding (clinical evaluation / physical) that is interpreted by the Investigator as a risk to the subject 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 subject of the study;
  • Hypersensitivity to the drug components used 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
  • Participants with glucose-6-phosphate dehydrogenase(G6PD) deficiency due to increased risk of hemolysis associated with the use of paracetamol;
  • 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: Participants 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 02 weeks before the screening visit (V0);
  • Subjects with hepatic or renal failure;
  • Subjects 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Brazil6 sites

  • Centro de Pesquisa Clínica Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul

  • Centro de Pesquisa Clínica - CPEC / Associação Obras Sociais Irmã Dulce

    Salvador, Estado de Bahia

  • Centro de Desenvolvimento em Estudos Clínicos Brasil - CDEC Brasil

    São Paulo

  • Cepic - Centro Paulista de Investigação Clínica

    São Paulo

  • CPCLIN - Centro de Pesquisas Clinicas Ltda

    São Paulo

  • Universidade Federal de São Paulo - Núcleo de Gestão de Pesquisa/HU/FAP

    São Paulo

Other trials in Brazil

About this study

Official title: National, Phase III, Multicenter, Randomized, Open, Parallel, to Evaluate the Efficacy, Safety and Superiority of Cefalium® Compared to the Tylenol® in the Treatment of Migraine Attacks

National clinical trials, phase III, randomized, open, parallel, study of superiority, in which three hundred thirty-six (336) participants of both sexes, aged between 18 and 65 years will be randomly allocated to one of two treatment groups. The Group 01 will use Cefalium® and group 02 will use Tylenol®.

Read the detailed description

Cefalium® is a combination of Caffeine + Paracetamol + dihydroergotamine mesylate + metoclopramide hydrochloride. The dihydroergotamine mesylate interacts with the serotonergic, dopaminergic and noradrenergic receptors, but it's mechanism is not totally known. 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). The Metoclopramide hydrochloride presents an anti-emetic action and prokinetic action in the gastrointestinal tract.One of its properties is the inhibition of nausea and vomiting triggered by drugs such as ergotamine.Paracetamol, also called acetaminophen is an effective agent analgesic and antipyretic with weak anti-inflammatory activity.

Conditions
Migraine
Being tested
Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide., Acetaminophen
Keywords
Headache, Aura, Migraine, Moderate to Severe
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.

  • Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide.Drug

    Also called Cefalium

    The subject must manage 02 tablets of Cefalium right after a moderate to severe migraine.

  • AcetaminophenDrug

    Also called Tylenol

    The subject must manage 02 tablets of Tylenol right after a moderate to severe migraine.

Study groups in NCT02582996
Study groupRoleWhat they receive
Cefalium®ExperimentalAcetaminophen+Caffeine+Dihydroergotamine+Metoclopramide.
Receives: Drug: Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide.
Tylenol®Active comparatorAcetaminophen
Receives: Drug: Acetaminophen

What is being measured

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

  1. Pain relief of Cefalium® compared to Tylenol®

    Relief of pain 2 hours after taking medication, being considered to reduce the intensity from strong(3) or moderate(2), at baseline, to mild(1) or absent(0) 2 hours after taking the medication, according to the functional and behavioral debilitating categorical scale without use of rescue medication as annotations the diary of symptoms

    Measured: 2 hours

Secondary outcomes (6)

  1. Pain decrease after use of investigational product, without a rescue medication

    Number of participants with pain decrease in 2 hours and 4 hours after the use of the investigational product,at 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: Up to 4 hours

  2. Pain decrease after use of the investigational product, without a rescue medication

    Number of participants with pain relief in 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: 4 hours

  3. Pain relief maintenance during the period 4-24 hours after use of investigational product

    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 rescue medication during this period;

    Measured: Up to 24 hours

  4. Nausea/vomiting Symptoms Free

    Participants free of nausea/vomiting symptoms 2 and 4 hours after use of investigational product,at the first migraine attack of moderate to severe pain 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: Up to 4 hours

  5. Photophobia/Phonophobia Symptoms Free

    Participants free of photophobia/phonophobia symptoms 2 and 4 hours after use of investigational product, at the first migraine attack of moderate to severe pain 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: Up to 4 hours

  6. Need of a rescue medication

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

    Measured: Up to 24 hours

Timeline

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

  1. First posted21 Oct 2015 (estimated)
  2. Study startApr 2020 (estimated)
  3. Primary completionApr 2021 (estimated)
  4. Study completionJun 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
None (open label)
Enrolment
336 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02582996
Sponsor's protocol ID
ACH-CFL-03(01/14)
Status last verified
Apr 2019
First submitted
31 Mar 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 testing Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide. and Acetaminophen in people with Migraine, run by Ache Laboratorios Farmaceuticos S.A. at 6 sites 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 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: paused, 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 6 sites 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?

Results are not available in the source record.

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?

Pain relief of Cefalium® compared to Tylenol® (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 NCT02582996.

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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