Migraine And Headache
This randomized, open-label study examined participant reported outcomes, safety, and tolerability of onabotulinumtoxinA and topiramate in adults with chronic migraines.
Fremanezumab, an anti-CGRP monoclonal antibody, is currently being reviewed by the Food and Drug Administration (FDA) as a quarterly or monthly injection for the preventive treatment of migraine in adults.
The antiepileptic drug levetiracetam may represent an effective prophylactic treatment option for episodic migraine.
A total of 858 adults with at least a 1-year history of migraine, 4 to 14 migraine headache days per month, and a mean of at least 2 migraine attacks per month within the past 3 months received once-monthly treatments for 6 months and were followed up for 5 months after the last injection.
The efficacy of Aimovig was evaluated as a preventive treatment of episodic or chronic migraine in 3 randomized, double-blind, placebo-controlled studies: 2 studies in patients with episodic migraine (4-14 migraine days per month) and 1 study in patients with chronic migraine (≥15 headache days per month with ≥8 migraine days per month).
In this randomized controlled trial, Fremanezumab slightly decreased the amount of headache free days in those with episodic migraines compared to placebo.
The researchers found that over 12 weeks, mean migraine days per month decreased from 8.9 to 4.9 days, from 9.2 to 5.3 days, and from 9.1 to 6.5 days in the fremanezumab monthly dosing group, the fremanezumab single-higher-dose group, and the placebo group, respectively.
The episodic cluster headache trial included a total of 106 patients with an average of 17.5 cluster headache attacks per week at baseline.
Compared to placebo, selective serotonin reuptake inhibitors (SSRIs) were associated with a significantly higher risk of headache (risk ratio [RR] 1.06, 95% CI: 1.00 to 1.13; P =.045).
Results showed that 14.3%, 20.7% (P=.0285), and 21.8% (P=.0129) achieved pain freedom in the placebo, ubrogepant 25mg dose, and 50mg dose groups, respectively.
"Our results show that people who thought their migraines were difficult to prevent may actually have hope of finding pain relief," Reuter said in a statement.
The application assesses 3 key balance metrics: (1) double stance, (2) right tandem stance, and (3) left tandem stance.
"This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention," the authors write.
DFN-02 was evaluated in a multicenter, double-blind, randomized, placebo-controlled study (N=107) which showed it was effective in treating pain and associated symptoms during a migraine attack and in reducing attack-related functional disability.
A total of 1,327 migraine patients were treated in the study for a single migraine attack. At 2 hours after migraine attack, 19.2% (n=423) and 21.2% (n=448) of ubrogepant 50mg and 100mg were pain free, respectively.
There were positive associations for migraine with myocardial infarction, ischemic stroke and hemorrhagic stroke, venous thromboembolism, and atrial fibrillation or flutter.
The new approval for migraine patients was supported by the PRESTO trial, a multicenter, randomized, double-blind, sham-controlled trial.
Aimovig is a fully human monoclonal antibody, designed to selectively block the calcitonin gene-related peptide (CGRP) receptor.
The 'PROMISE 2' study included 1,072 patients who were randomized to receive eptinezumab (300mg or 100mg), or placebo once every 12 weeks.
Results from the CM trial found that the fremanezumab arm experienced statistically significant reduction in the number of monthly headache days of at least moderate severity vs. placebo.
The new and revised standards from The Joint Commission were published in July 2017 to address some of the issues associated with over-prescribing and lack of monitoring.
Migraine days were cut by ≥50% for half of the 140mg group, by 43.3% for the 70mg group, and by 26.6% for the placebo group.
The Food and Drug Administration (FDA) approval was based on several studies that demonstrated 1 hour of use with Cefaly Acute could relieve or stop the migraine headache.
The mean length of ketamine infusion was 5.1 days, with the lowest pain rating on day 4, which was achieved at mean ketamine rates of 30.8±3.6 mg/hr less than the maximum dose.