Ticagrelor for Refractory Migraine/Patent Foramen Ovale (TRACTOR): An open-label pilot study.

OBJECTIVE: After finding that the thienopyridines clopidogrel and prasugrel reduced migraine headache (MHA) symptoms in some patients with patent foramen ovale (PFO), this small pilot study was undertaken to determine whether ticagrelor, a nonthienopyridine P2Y12 inhibitor, would have similar MHA effects and might be better suited for a future randomized trial. METHODS: MHA patients were screened for PFO. Participants with documented right to left shunt (RLS) and ≥6 monthly MHA days received ticagrelor therapy for 28 days. Those with ≥50% reduction in monthly MHA days were deemed responders and completed 2 additional treatment months. RESULTS: The 40 participants had a mean age of 36.2 years and mean MHA frequency of 17.4 d/mo. A total of 39/40 were female. A total of 14/40 met criteria for episodic MHA, 26/40 for chronic MHA, 14/40 had migraine with aura, and 22/40 had a moderate-large RLS (Spencer grade ≥4). Seventeen of 40 participants (43%) were responders. MHA reduction continued through 3 treatment months in all responders. MHA responder rates were not statistically different in participants with episodic or chronic MHA, with or without aura, or with small/larger RLS shunt magnitude. Thirteen (32%) patients had medication side effects, without serious adverse events. CONCLUSION: P2Y12 inhibition with ticagrelor reduced MHA symptoms similarly to our previous thienopyridine experience, but participants seemed to have a less robust MHA benefit and more frequent side effects than with the thienopyridines, making it an inferior choice for a randomized trial. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that ticagrelor reduced MHA symptoms in patients with PFO.

External Trigeminal Nerve Stimulation for the Acute Treatment of Migraine: Open-Label Trial on Safety and Efficacy.

OBJECTIVE: The aim of the current study is to assess the safety and efficacy of external trigeminal nerve stimulation (e-TNS) via a transcutaneous supraorbital stimulator as an acute treatment for migraine attacks. MATERIALS AND METHODS: This was a prospective, open-labeled clinical trial conducted at the Columbia University Headache Center (NY, USA). Thirty patients who were experiencing an acute migraine attack with or without aura were treated with a one-hour session of e-TNS (CEFALY Technology) at the clinic. Pain intensity was scored using a visual analogue scale (VAS) before the treatment, after the one-hour treatment session, and at two hours after treatment initiation. Rescue migraine medication intake was recorded at 2 and 24 hours. RESULTS: Thirty patients were included in the intention-to-treat analysis. Mean pain intensity was significantly reduced by 57.1% after the one-hour e-TNS treatment (-3.22 ± 2.40; p < 0.001) and by 52.8% at two hours (-2.98 ± 2.31; p < 0.001). No patients took rescue medication within the two-hour observation phase. Within the 24-hour follow-up, 34.6% of patients used a rescue medication. No adverse events or subjective complaints were reported. CONCLUSIONS: The findings from this open-labeled study suggest that transcutaneous supraorbital neurostimulation may be a safe and effective acute treatment for migraine attacks, and merits further study with a double-blind, randomized, sham-controlled trial.