Partial rebreathing is not effective for early treatment of migraine with aura attacks: Results of a double-blind, randomized, controlled trial (PAREMA1)
Abstract
Objective: Evaluate the efficacy and safety of a novel partial rebreathing device for early treatment of acute attacks of migraine with aura.
Background: Earlier clinical studies have indicated a potential for CO2-enriched gas to be effective for acute treatment of migraine with aura, especially when applied during the early part of the aura stage. We developed a partial rebreathing device inducing moderate, steady-state hypercapnia with normoxia in order to provide a carbon dioxide delivery system combining efficacy, usability, safety, and affordability.
Methods: This randomized, double-blind, sham-controlled, parallel-group, group-sequential study was conducted at 15 study sites, nine located in the United States and six in Germany, between March 2023 and February 2025. The study enrolled patients aged 18-65 years with migraine with aura. The study had a sequential two-stage study design. At the beginning of stage 1, participants were randomized to active or sham and treated up to four attacks. Participants were instructed to treat from the onset of aura and until 5 min after aura cessation. After having reported four attacks in stage 1, participants had the option to continue into stage 2, an open-label extension in which they could treat up to five attacks with the active device. During stage 1, participants recorded symptom scores in a study diary app at the onset of aura and after 1, 2, 24, and 48 h.
Results: The study was terminated at the interim analysis point due…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 142 participants or records.
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