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

NCT02706015 | Withdrawn Phase 3

• 1 other identifier: ACH-CFL-03(10/14)
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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®.

Conditions

Migraine Headache

Keywords

Headache; Aura; Migraine

Outcome Measures

Primary Outcomes (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.

  2 Hours

Secondary Outcomes (5)

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

  2 and 4 hours after taking the medication

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

  2 and 4 hours after taking the medication

• 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

  4 to 24 hours after taking the medication

• Need for use of a rescue medication.

  2 to 24 hours after taking the experimental drug

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

  2 to 4 hours after taking the medication

Study Arms (2)

Cefaliv® & Placebo

EXPERIMENTAL

Dihydroergotamine mesylate+ dipyrone sodium + caffeine

Drug: Cefaliv® & Placebo

Neosaldina® & Placebo

ACTIVE COMPARATOR

Isometheptene mucate + dipyrone sodium + anhydrous caffeine

Drug: Neosaldina® & Placebo

Interventions

Cefaliv® & Placebo DRUG

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

Also known as: Cefaliv® (Dihydroergotamine mesylate+ dipyrone sodium + caffeine) & Placebo

Cefaliv® & Placebo

Neosaldina® & Placebo DRUG

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

Also known as: Neosaldina® (Isometheptene mucate + dipyrone sodium + anhydrous caffeine) & Placebo

Neosaldina® & Placebo

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (1)

Ache Laboratorios Farmaceuticos

Guarulhos, São Paulo, Brazil

Location

MeSH Terms

Conditions

Migraine Disorders; Headache; Epilepsy

Interventions

Caffeine

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)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: March 11, 2016
• Study Start: October 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

BR (1)