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The objective of a 52-week extension Phase-3, open-label, dose-blinded study was to assess the effectiveness of Ubrogepant to manage migraine with mild vs. severe or moderate pain.
In adults diagnosed with migraine, treatment with Ubrogepant (50 mg or 100 mg) when pain is mild raises the likelihood of attaining positive outcomes, relative to the treatment of moderate or severe pain.
The objective of a 52-week extension Phase-3, open-label, dose-blinded study was to assess the effectiveness of Ubrogepant to manage migraine with mild vs. severe or moderate pain.
Adult migraine sufferers were randomly segregated to usual care, 50 mg Ubrogepant, and 100 mg Ubrogepant. Every four weeks, participants were treated upto eight attacks of migraine with varying degrees of pain. Effectiveness results (only gathered for Ubrogepant) were freedom from disability, freedom from symptoms, and 2-hour pain freedom (2hPF). In this post hoc analysis, the impact of baseline pain intensity on therapy outcomes was determined with the aid of a generalized linear mixed model along with logit link function and binomial distribution.
Data on 19,291 attacks from subjects (n = 808) were incorporated. For attacks treated with Ubrogepant 50 mg (47.1% against 23.6%; Odds ratio [OR]=2.89) and Ubrogepant 100 mg (55.2% versus 26.1%; OR=3.50), 2hPF rates were greater when the pain was mild compared to severe or moderate pain. Following treatment of mild pain vs. severe or moderate pain, the rates of relief from nausea, phonophobia, and photophobia 2 hours after treatment were considerably higher.
For both doses of Ubrogepant, the percentage of attacks with normal function at two hours was greater than double. The most frequently noted side effect was upper respiratory tract infection (∼11% for both dosages). For Ubrogepant 50mg and Ubrogepant 100 mg, 2% and 3% of volunteers witnessed severe adverse effects, respectively.
Treatment with Ubrogepant during mild pain led to noticeably greater rates of freedom from pain, freedom from accompanying symptoms, and regaining normal function 2 hours post-administration compared to attacks treated with severe or moderate pain.
Neurology
Efficacy of Ubrogepant in the Acute Treatment of Migraine With Mild Pain Versus Moderate or Severe Pain
Richard B. Lipton et al.
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