Migraine and Headache
The FOCUS study enrolled a total of 838 patients who experienced chronic or episodic migraines and had inadequate responses (defined as lack of efficacy after at least 3 months of therapy; or the patient cannot tolerate the drug; or the drug is contraindicated; or the drug is not suitable for the patient) to other classes of drugs (ie, beta-blockers, anticonvulsants, tricyclics, calcium channel blockers, angiotensin II receptor antagonists, onabotulinumtoxinA, valproic acid).
Migraine with aura is associated with an elevated risk for incident atrial fibrillation, according to a new study.
In Study 303 (N=1375), rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, achieved statistical significance in 2 co-primary endpoints: pain freedom and freedom from most bothersome symptom (MBS).
Recommendations on the use of these agents in this patient population were published in a Views and Perspectives paper in the journal Headache.
The approval was based on data from 3 randomized, double-blind, placebo-controlled trials (EVOLVE-1, EVOLVE-2, REGAIN) in patients with either episodic or chronic migraine.
The primary efficacy endpoint was the mean change from baseline in the monthly average number of headache days of at least moderate severity during the 3-month treatment period.
The Sapphire has a rechargeable and reloadable fill capacity; it can be activated monthly by inputting a unique, prescription-only authorization code, delivered via a radio-frequency identification card that is mailed to the patient.
The label includes a Boxed Warning describing the risk of hepatotoxicity associated with APAP. Most cases of liver injury were associated with APAP doses >4000mg daily and often involved >1 APAP-containing product.
For the migraine and non-migraine cohorts, the incidence rates of cochlear disorders were 81.4 and 29.4 per 1 million person-years, respectively.
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.