A5076401268- Migraine and Headache Studies
- Neurological Disorders and Treatments
- Trigeminal Neuralgia and Treatments
- Botulinum Toxin and Related Neurological Disorders
- Ophthalmology and Eye Disorders
- Psychosomatic Disorders and Their Treatments
- Attention Deficit Hyperactivity Disorder
- Cardiovascular Syncope and Autonomic Disorders
- Pain Management and Placebo Effect
- Cancer Treatment and Pharmacology
- Toxin Mechanisms and Immunotoxins
- Developmental Biology and Gene Regulation
- Plant-based Medicinal Research
- Acne and Rosacea Treatments and Effects
- Neurobiology of Language and Bilingualism
- Phytochemistry and biological activities of Ficus species
- Diet and metabolism studies
- Functional Brain Connectivity Studies
- Bipolar Disorder and Treatment
- Neurobiology and Insect Physiology Research
- Olfactory and Sensory Function Studies
- Spine and Intervertebral Disc Pathology
- Electroconvulsive Therapy Studies
- Dementia and Cognitive Impairment Research
- Sympathectomy and Hyperhidrosis Treatments
AbbVie (United States)
2021-2025
King's College London
2010-2024
Thomas Jefferson University
2024
Mayo Clinic
2024
AbbVie (Japan)
2021-2023
Abington Memorial Hospital
2023
Mayo Clinic in Florida
2022
Mayo Clinic in Arizona
2022
Albert Einstein College of Medicine
1996-2022
Harvard University
2022
To evaluate the long-term safety and tolerability of ubrogepant for acute treatment migraine.Ubrogepant is an oral, calcitonin gene-related receptor antagonist in development migraine. The efficacy was demonstrated 2 phase 3 trials which a significant improvement observed migraine headache pain, migraine-associated symptoms, ability to function.This 3, multicenter, randomized, open-label, 52-week extension trial. Adults with or without aura entered trial after completing one lead-in were...
Objective To evaluate the efficacy of ubrogepant on patient‐reported functional disability, satisfaction with study medication, and global impression change. Background Ubrogepant is a small‐molecule, oral calcitonin gene‐related peptide receptor antagonist indicated for acute treatment migraine. In 2 phase 3 trials (ACHIEVE I II), demonstrated vs placebo co‐primary endpoints headache pain freedom absence most bothersome migraine‐associated symptom at hours post dose 50 100 mg doses....
Abstract PRODROME was a phase 3, placebo-controlled, double-blind crossover trial evaluating whether ubrogepant 100 mg, calcitonin gene-related peptide receptor antagonist, dosed during the premonitory (prodromal) of migraine, prevented development headache and resolved prodromal symptoms. Qualifying events were defined as attacks with symptoms in which participant confident would follow within 1–6 h. Of 1,087 screened participants, 477 formed efficacy analysis population. Outcomes collected...
The authors determined the efficacy and safety of asenapine in preventing recurrence any mood episode adults with bipolar I disorder.Adults an acute manic or mixed per DSM-IV-TR criteria were enrolled this randomized, placebo-controlled trial consisting initial 12- to 16-week open-label period a 26-week double-blind randomized withdrawal period. target dosage was 10 mg b.i.d. but could be titrated down 5 After completing period, subjects meeting stabilization/stable-responder placebo...
Limited data are available describing the frequency, severity, and consistency of prodromal symptoms followed by headache. This analysis PRODROME trial screening period characterized in people with migraine, including most common their frequency which were
To examine the safety and efficacy of ubrogepant for acute treatment migraine across cardiovascular (CV) disease risk categories.ACHIEVE I II were multicenter, double-blind, single-attack, phase 3 trials in adults with migraine, or without aura. Participants randomized 1:1:1 to placebo (50 100 mg ACHIEVE I; 25 50 II), treat one attack moderate severe headache pain intensity. This post-hoc analysis pooled data from groups by baseline factors. Using a assessment algorithm, participants...
Background This study was designed to assess changes in brain volume and cognitive abilities memantine‐treated patients with Alzheimer's disease (AD) by using an exploratory, single‐arm, delayed‐start design. Methods Cholinesterase inhibitor‐treated AD (N = 47; Mini‐Mental State Examination score range: 15–23) were enrolled observational lead‐in period (weeks: 1–24), followed open‐label of add‐on memantine treatment 25–48). The underwent magnetic resonance imaging at weeks 0 (baseline), 24...
Ubrogepant is an oral, small-molecule calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine. The efficacy and safety ubrogepant were demonstrated in two pivotal phase 3, single-attack, randomized, placebo-controlled trials (ACHIEVE I ACHIEVE II).We conducted a post hoc analysis pooled data from to evaluate efficacy, safety, tolerability 50 mg (the only dose evaluated both trials) versus placebo across large population participants with coprimary...
<h3>Background and Objectives</h3> To examine the efficacy of ubrogepant in treatment migraine with mild vs moderate or severe pain. <h3>Methods</h3> This was a phase 3, open-label, dose-blinded, 52-week extension trial. Adults were randomized 1:1:1 (usual care, 50 mg, 100 mg). Participants treated up to 8 attacks any pain intensity every 4 weeks. Efficacy outcomes (only collected for ubrogepant) included 2-hour freedom (2hPF), from associated symptoms, disability. A generalized linear mixed...
<h3>Objective:</h3> To evaluate the efficacy, safety, and tolerability of ubrogepant 100 mg when administered during prodrome (premonitory phase) a migraine attack. <h3>Background:</h3> Ubrogepant is calcitonin gene-related peptide (CGRP) receptor antagonist approved for acute treatment migraine. The earliest phase attack characterized by symptoms other than aura, which precede onset headache. This study examined potential ubrogepant, prodrome, to prevent or attenuate headache disability....
Atogepant is an oral, small-molecule, calcitonin gene-related peptide receptor antagonist for the preventive treatment of episodic migraine.In this 52-week, multicenter, randomized, open-label trial, adults with 4-14 monthly migraine days received atogepant 60 mg once-daily or standard care. Health outcome endpoints collected from participants randomized to included change baseline in Migraine-Specific Quality Life Questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive (RFR),...
<h3>Objective:</h3> To evaluate efficacy, safety, and tolerability of atogepant for preventive treatment chronic migraine (CM). <h3>Background:</h3> Atogepant is an oral CGRP receptor antagonist approved in the US episodic migraine. <h3>Design/Methods:</h3> PROGRESS(NCT03855137) was a 12-week phase 3 trial adults with CM who were randomized to (30mg twice daily [BID], 60mg once [QD]) or placebo. Primary efficacy endpoint change from baseline mean monthly days (MMDs) over 12 weeks. A key...
<h3>Objective:</h3> To evaluate the efficacy of ubrogepant 100 mg to treat migraine symptoms during prodrome (premonitory phase). <h3>Background:</h3> Ubrogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for acute treatment migraine. The primary objective PRODROME trial was prevent or attenuate headache following administration prodrome. Additionally, study rigorously assessed effect on prodromal symptoms. <h3>Design/Methods:</h3> (NCT04492020) multicenter,...
To evaluate the efficacy and safety of ubrogepant for acute treatment perimenstrual migraine (pmM) attacks.Ubrogepant is an oral calcitonin gene-related peptide receptor antagonist approved in adults.After completing one two phase 3 trials, participants could enroll a 3, 52-week, open-label, long-term extension trial were re-randomized 1:1:1 to usual care, 50 mg, or 100 mg. This post hoc analysis evaluated subset women who treated ≥1 pmM non-pmM attack with ubrogepant. A started on between 2...
<h3>Objective:</h3> Characterize prodromal (premonitory) symptoms and time to onset of headache in people with migraine who stated they could identify attacks reliably followed by headache. <h3>Background:</h3> The PRODROME trial assessed the efficacy, safety, tolerability ubrogepant vs placebo preventing moderate or severe when administered during prodrome. screening period was used characterize eligible participants. <h3>Design/Methods:</h3> (NCT04492020) enrolled adults 2–8 per month that...
Post hoc analyses of placebo-controlled studies suggest that memantine treatment may benefit language and conversation abilities patients' with Alzheimer's disease (AD). This study prospectively evaluated the effects on functional communication in patients moderate AD. Native English-speaking outpatients (N=265) AD (MMSE range: 10-19) participated a 12-week, international, double-blind, randomized, (20 mg/day) versus placebo. Concurrent cholinesterase inhibitor treatment, stable throughout...
To evaluate the safety and tolerability of ubrogepant from pooled ACHIEVE I II trials.
Assess the efficacy of ubrogepant 50 or 100 mg within participants who treated migraine attacks with mild and moderate/severe pain during a 52-week treatment period.
Monday, April 27April 14, 2020Free AccessSafety and Efficacy of Ubrogepant in Participants With Moderate to High Cardiovascular Risk (107)Lawrence Severt, Stephen D. Silberstein, Andrew M. Blumenfeld, Richard B. Lipton, Kaifeng Lu, Sung Yun Yu, Susan HutchinsonAuthors Info & AffiliationsApril 2020 issue94 (15_supplement)https://doi.org/10.1212/WNL.94.15_supplement.107 Letters the Editor
Monday, April 27April 14, 2020Free AccessEfficacy Is Maintained With Long-term Intermittent Use of Ubrogepant for the Acute Treatment Migraine (111)Joel M. Trugman, Jessica Ailani, Susan Hutchinson, Kerry Knievel, Kaifeng Lu, Sung Yun Yu, Michelle Finnegan, Lawrence Severt, Armin Szegedi, and Richard B. LiptonAuthors Info & AffiliationsApril 2020 issue94 (15_supplement)https://doi.org/10.1212/WNL.94.15_supplement.111 Letters to Editor
To determine the efficacy and safety of ubrogepant in acute treatment perimenstrual migraine (pmM) attacks.