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

This study is not yet open for participant recruitment.
Verified February 2017 by Ache Laboratorios Farmaceuticos S.A.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02582996
First Posted: October 21, 2015
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.
  Purpose
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®.

Condition Intervention Phase
Migraine Drug: Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide. Drug: Acetaminophen Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ache Laboratorios Farmaceuticos S.A.:

Primary Outcome Measures:
  • Pain relief of Cefalium® compared to Tylenol® [ Time Frame: 2 hours ]
    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


Secondary Outcome Measures:
  • Pain decrease after use of investigational product, without a rescue medication [ Time Frame: Up to 4 hours ]
    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

  • Pain decrease after use of the investigational product, without a rescue medication [ Time Frame: 4 hours ]
    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;

  • Pain relief maintenance during the period 4-24 hours after use of investigational product [ Time Frame: Up to 24 hours ]
    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;

  • Nausea/vomiting Symptoms Free [ Time Frame: Up to 4 hours ]
    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.

  • Photophobia/Phonophobia Symptoms Free [ Time Frame: Up to 4 hours ]
    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.

  • Need of a rescue medication [ Time Frame: Up to 24 hours ]
    Number of participants who use at least once the rescue medication in a 2-24 hours period after use of the investigational product.


Other Outcome Measures:
  • Variation in laboratory exams ratings [ Time Frame: From baseline visit until 30 days after the end of the treatment ]
    Number of participants with any relevant variation in laboratory exams from baseline visit until 30 days after the end of the treatment

  • Variation in clinical exams ratings [ Time Frame: From baseline visit until 30 days after the end of the treatment ]
    Number of participants with any relevant variation in clinical exams from baseline visit until 30 days after the end of the treatment

  • Variation in physical exams ratings [ Time Frame: From baseline visit until 30 days after the end of the treatment ]
    Number of participants with any relevant variation in physical exams from baseline visit until 30 days after the end of the treatment

  • Participants with adverse events [ Time Frame: From baseline visit until 30 days after the end of the treatment ]
    Number of participants with any adverse events from baseline visit until 30 days after the end of the treatment


Estimated Enrollment: 336
Anticipated Study Start Date: April 2018
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cefalium®
Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide.
Drug: Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide.
The subject must manage 02 tablets of Cefalium right after a moderate to severe migraine.
Other Name: Cefalium
Active Comparator: Tylenol®
Acetaminophen
Drug: Acetaminophen
The subject must manage 02 tablets of Tylenol right after a moderate to severe migraine.
Other Name: Tylenol

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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);
    • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582996


Contacts
Contact: Elisangela Rorato +55 11 2608-6130 Elisangela.rorato@ache.com.br

Locations
Brazil
Centro de Pesquisa Clínica - CPEC / Associação Obras Sociais Irmã Dulce Not yet recruiting
Salvador, Bahia, Brazil
Centro de Pesquisa Clínica Hospital São Lucas da PUCRS Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Desenvolvimento em Estudos Clínicos Brasil - CDEC Brasil Not yet recruiting
São Paulo, Brazil
Cepic - Centro Paulista de Investigação Clínica Not yet recruiting
São Paulo, Brazil
CPCLIN - Centro de Pesquisas Clinicas Ltda Not yet recruiting
São Paulo, Brazil
Universidade Federal de São Paulo - Núcleo de Gestão de Pesquisa/HU/FAP Not yet recruiting
São Paulo, Brazil
Sponsors and Collaborators
Ache Laboratorios Farmaceuticos S.A.
Investigators
Principal Investigator: Thais Villa Federal University of São Paulo
  More Information

Responsible Party: Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier: NCT02582996     History of Changes
Other Study ID Numbers: ACH-CFL-03(01/14)
First Submitted: March 31, 2015
First Posted: October 21, 2015
Last Update Posted: February 15, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
Headache
Aura
Migraine
Moderate to Severe

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acetaminophen
Dihydroergotamine
Metoclopramide
Caffeine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents