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Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine

Primary Purpose

Migraine

Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Rizatriptan 10 mg + Naproxen 550mg
Maxalt 10Mg Tablet
Flanax 550mg
Placebo oral tablet
Sponsored by
Eurofarma Laboratorios S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients of both sexes;
  • Aged between 18 and 65 years old;
  • Capable and willing to give free and informed informed consent in writing;
  • Migraine patients with or without aura, according to the International Headache Society (IHS).

Exclusion Criteria:

  • Chronic migraine;
  • Headache other than migraine (that is, tension-type headache, sinusitis, etc.).

Sites / Locations

  • CEPICRecruiting
  • Eurofarma Laboratorios S.ARecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Rizatriptan 10mg+ Naproxen 550mg

Maxalt 10mg

Flanax 550mg

Placebo

Arm Description

Rizatriptan 10mg+ Naproxen 550mg

Rizatriptan10mg

Naproxen 550mg

Placebo

Outcomes

Primary Outcome Measures

2-hour pain-free
2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)

Secondary Outcome Measures

Most bothersome migraine-associated symptom
Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)

Full Information

First Posted
April 6, 2020
Last Updated
May 4, 2023
Sponsor
Eurofarma Laboratorios S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04384367
Brief Title
Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine
Official Title
A Multicenter, Double-blind, Double-dummy, Randomized, Single-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2022 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
January 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A phase III study, multicenter, double-blind, double-dummy, randomized, single-dose, placebo-controlled study to evaluate the efficacy and safety of Rizatriptan-Naproxen (10/550 mg) in the acute treatment of migraine. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Detailed Description
This is a prospective, randomized, double-blind, double-dummy and placebo-controlled study in individuals with disabling migraine. The participants will be randomized to receive Rizatriptan + Naproxen (10/550mg), Rizatriptan (10mg), Naproxen (550mg) or placebo. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1664 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rizatriptan 10mg+ Naproxen 550mg
Arm Type
Experimental
Arm Description
Rizatriptan 10mg+ Naproxen 550mg
Arm Title
Maxalt 10mg
Arm Type
Active Comparator
Arm Description
Rizatriptan10mg
Arm Title
Flanax 550mg
Arm Type
Active Comparator
Arm Description
Naproxen 550mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Rizatriptan 10 mg + Naproxen 550mg
Other Intervention Name(s)
Medicamento
Intervention Description
oral - single dose
Intervention Type
Drug
Intervention Name(s)
Maxalt 10Mg Tablet
Other Intervention Name(s)
Medicamento
Intervention Description
oral - single dose
Intervention Type
Drug
Intervention Name(s)
Flanax 550mg
Other Intervention Name(s)
Medicamento
Intervention Description
oral - single dose
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Other Intervention Name(s)
Medicamento
Intervention Description
oral - single dose
Primary Outcome Measure Information:
Title
2-hour pain-free
Description
2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
Most bothersome migraine-associated symptom
Description
Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)
Time Frame
11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients of both sexes; Aged between 18 and 65 years old; Capable and willing to give free and informed informed consent in writing; Migraine patients with or without aura, according to the International Headache Society (IHS). Exclusion Criteria: Chronic migraine; Headache other than migraine (that is, tension-type headache, sinusitis, etc.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edilene Macedo, Analyst
Phone
5511 5090-8422
Email
edilene.macedo@eurofarma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia A Gianni, Analyst
Phone
41449500
Email
natalia.gianni@eurofarma.com
Facility Information:
Facility Name
CEPIC
City
São Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Pádua
Email
vanessa.padua@cepic.com.br
Facility Name
Eurofarma Laboratorios S.A
City
São Paulo
ZIP/Postal Code
06696-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edilene Macedo
Phone
55 11 50908600
Ext
8422
Email
edilene.macedo@eurofarma.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine

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