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

NCT02582996 | Suspended Phase 3

• 1 other identifier: ACH-CFL-03(01/14)
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 6

Brief 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®.

Conditions

Migraine

Keywords

Headache; Aura; Migraine; Moderate to Severe

Outcome Measures

Primary Outcomes (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

  2 hours

Secondary Outcomes (6)

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

  Up to 4 hours

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

  4 hours

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

  Up to 24 hours

• Nausea/vomiting Symptoms Free

  Up to 4 hours

• Photophobia/Phonophobia Symptoms Free

  Up to 4 hours

Other Outcomes (4)

• Variation in laboratory exams ratings

  From baseline visit until 30 days after the end of the treatment

• Variation in clinical exams ratings

  From baseline visit until 30 days after the end of the treatment

• Variation in physical exams ratings

  From baseline visit until 30 days after the end of the treatment

Study Arms (2)

Cefalium®

EXPERIMENTAL

Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide.

Drug: Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide.

Tylenol®

ACTIVE COMPARATOR

Acetaminophen

Drug: Acetaminophen

Interventions

Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide. DRUG

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

Also known as: Cefalium

Cefalium®

Acetaminophen DRUG

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

Also known as: Tylenol

Tylenol®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (6)

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

Salvador, Estado de Bahia, Brazil

Location

Centro de Pesquisa Clínica Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Location

Centro de Desenvolvimento em Estudos Clínicos Brasil - CDEC Brasil

São Paulo, Brazil

Location

Cepic - Centro Paulista de Investigação Clínica

São Paulo, Brazil

Location

CPCLIN - Centro de Pesquisas Clinicas Ltda

São Paulo, Brazil

Location

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

São Paulo, Brazil

Location

MeSH Terms

Conditions

Migraine Disorders; Headache; Epilepsy

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Thais Villa

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: October 21, 2015
• Study Start: April 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

BR (6)