Incorporating Remote Electrical Neuromodulation (REN) Into Usual Care Reduces Acute Migraine Medication Use: An Open-Label Extension Study (NCT03361423)

Background

Medication overuse headache (MOH) may occur in patients with migraine as a consequence of frequent acute medication use with treatments such as triptans, ergots, barbiturates, or opiates as a complication of their underlying condition. Thus, a non-pharmacological treatment may reduce the percentage of patients suffer from MOH.

A recent randomized controlled study showed that 66.7% (66/99) and 37.4% (37/99) of people undergoing Nerivio treatment, achieve pain relief and pain freedom, respectively, at 2 h post-treatment. The participants who completed the 6-weeks double blind phase of this study were offered to participate in an open-label extension (OLE) with an active Nerivio device.

Study aims

This study investigated the clinical use of Nerivio, focusing on its potential in reducing the use of acute migraine medications.

Methods:

Participants continued in an 8-weeks OLE phase in which they could incorporate the Nerivio device into their usual care. Medication use rates were compared between the OLE and the run-in phase (4-weeks baseline) in a within-subject design.

Results

The analyses were performed on 117 participants with episodic migraine. During the OLE, 89.7% of the participants treated their attacks only with Nerivio and avoided medications in all their attacks compared with 15.4% in the run-in phase (p < 0.0001). The rates of pain relief and pain-freedom in at least 50% of the treatments at 2 h post-treatment were comparable (pain relief: 58.1% in the run-in phase and 57.3% in the OLE, p = 0.999; pain-free: 23.1% in the run-in vs. 30.8% in the OLE, p = 0.175).

During the OLE, 89.7% (105/117) of the participants treated their attacks only with Nerivio and avoided medications in all their reported attacks compared with 15.4% (18/117) in the run-in phase (p < 0.000). When Nerivio was available for the acute treatment of the attacks, 73.5% (86/117) of the participants achieved ≥50% reduction in the number of attacks treated with medication and 42.7% (50/117) achieved 100% reduction in the number of attacks treated with medication.

Conclusions

Nerivio may reduce the use of acute migraine medications intake. Thus, incorporating Nerivio into usual care treatment regime may reduce the risk for medication overuse headache (MOH).