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

NCT04384367
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Phase
Phase 3
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Recruitment status
Completed
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Participants
2,068
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Lead sponsor
Eurofarma Laboratorios S.A.
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Start date
2022-12-30
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Number of sites
2
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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).
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Acronym
RELIEF
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Short title
Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2024-11-30
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First posted
2020-05-12
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Registry last updated
2025-02-14
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Primary completion date
2024-10-30
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Start date
2022-12-30
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Actual participants
2,068
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Participants
2,068
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
2
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eurofarma Laboratorios S.A.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT04384367
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ClinicalTrials.gov ID
NCT04384367
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. 2-hour pain-free

    Timeframe: 11 weeks

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

  1. Most bothersome migraine-associated symptom

    Timeframe: 11 weeks

    Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  • 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).

  • Chronic migraine;
  • Headache other than migraine (that is, tension-type headache, sinusitis, etc.).
Sources for eligibility
clinicaltrials.gov

  • Eurofarma Laboratorios S.ASão Paulo, Brazil
  • CEPICSão Paulo, Brazil
Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (4)