Novel Therapy May Help Reduce Acute Migraine Medication Use

April 30, 2020
Gianna Melillo
Gianna Melillo

Gianna is an assistant editor of The American Journal of Managed Care® (AJMC®). She has been working on AJMC® since 2019 and has a BA in philosophy and journalism & professional writing from The College of New Jersey.

Incorporation of remote electrical neuromodulation into usual care reduced migraineurs’ use of acute migraine medication, potentially decreasing the risk of medication overuse headache, according to a study published in Frontiers in Neurology.

Incorporation of remote electrical neuromodulation (REN) into usual care reduced migraineurs’ use of acute migraine medication, potentially decreasing the risk of medication overuse headache (MOH), according to a study published in Frontiers in Neurology.

REN is a novel acute migraine treatment “in which upper arm peripheral nerves (median and musculocutaneous) are stimulated to induce conditioned pain modulation—a descending endogenous analgesic mechanism in which sub-threshold conditioning stimulation inhibits pain in remote body regions,” researchers said.

MOH occurs in migraineurs who frequently use medications like triptans, ergots, barbiturates, or opiates. High-frequency use of these medications may not only increase frequency and intensity of headaches, but it can also lead to adverse events such as gastrointestinal issues, renal toxicities, and medication dependency and withdrawal.

In a randomized, double-blind, sham-controlled study, 296 participants received acute treatment for migraine. This parent study included a run-in phase, in which migraine was treated with usual care, in addition to a double-blind REN treatment phase. Of the 296 participants, 160 migraineurs continued with an 8-week open-label extension (OLE), which incorporated REN into usual care. In total, analyses were performed on 117 study participants with episodic migraine, 57 of whom were in the active group during the double-blind treatment phase and 60 of whom were in the sham group.

Researchers compared medication use patterns during the OLE phase to rates in the run-in phase in a within-subject design. This design included OLE participants who used the REN device for treatment of at least 1 migraine attack. Pain intensity at the 2-hour posttreatment point was reported and compared between the cohorts.

The study yielded the following results:

  • Mean (SD) reported attacks across subjects were 3.44 (1.25) in the run-in phase and 3.21 (2.27) in the OLE phase
  • During the OLE, 89.7% (105/117) of the participants treated their attacks only with REN and avoided medications in all their reported attacks compared with 15.4% (18/117) in the run-in phase (P <.0001)
  • When REN was available for the acute treatment of the attacks, 73.5% (86/117) of the participants achieved a 50% or greater 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
  • In OLE, 57.3% (67/117) of participants achieved pain relief at 2 hours post treatment in at least 50% of their attacks, compared with 58.1% (68/117) in the run-in phase (P = 0.999)

Investigators also found that pain relief (P = .735) and pain-free (P = .099) outcomes were not dependent on whether participants were in the active or sham groups during the double-blind treatment phase. In addition, during the OLE, “pain relief rates were lower in triptan users, but pain-free response did not depend on triptan use.”

Because there was no reduction of pain relief and pain-free rates associated with the incorporation of REN into usual care, researchers concluded that the efficacy of REN is similar to usual care and “that reducing medication use (and using the device instead) did not hinder the relief of migraine pain.”

Researchers suggest that future studies take place to evaluate whether REN reduces the use of acute migraine medications in a population specifically at risk for MOH.

Reference

Marmura MJ, Lin T, Harris D, et al. Incorporating remote electrical neuromodulation (REN) into usual care reduces acute migraine medication use: an open-label extension study [published online April 7, 2020]. Front Neurol. doi: 10.3389/fneur.2020.00226.