Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine
RELIEF
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
1 other identifier
interventional
2,068
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2020
CompletedFirst Posted
Study publicly available on registry
May 12, 2020
CompletedStudy Start
First participant enrolled
December 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedFebruary 14, 2025
February 1, 2025
1.8 years
April 6, 2020
February 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
2-hour pain-free
2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)
11 weeks
Secondary Outcomes (1)
Most bothersome migraine-associated symptom
11 weeks
Study Arms (4)
Rizatriptan 10mg+ Naproxen 550mg
EXPERIMENTALRizatriptan 10mg+ Naproxen 550mg
Maxalt 10mg
ACTIVE COMPARATORRizatriptan10mg
Flanax 550mg
ACTIVE COMPARATORNaproxen 550mg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
oral - single dose
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Chronic migraine;
- Headache other than migraine (that is, tension-type headache, sinusitis, etc.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Eurofarma Laboratorios S.A
São Paulo, São Paulo, 06696-000, Brazil
CEPIC
São Paulo, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2020
First Posted
May 12, 2020
Study Start
December 30, 2022
Primary Completion
October 30, 2024
Study Completion
November 30, 2024
Last Updated
February 14, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share