A5060859207- Migraine and Headache Studies
- Olfactory and Sensory Function Studies
- Trigeminal Neuralgia and Treatments
- Botulinum Toxin and Related Neurological Disorders
- Psychosomatic Disorders and Their Treatments
- Sympathectomy and Hyperhidrosis Treatments
- Neurological Disorders and Treatments
- Cardiovascular Syncope and Autonomic Disorders
- Pharmacological Effects and Toxicity Studies
- Biomedical and Chemical Research
- Attention Deficit Hyperactivity Disorder
- Pharmaceutical studies and practices
- Substance Abuse Treatment and Outcomes
- Epilepsy research and treatment
- Respiratory and Cough-Related Research
- Health Systems, Economic Evaluations, Quality of Life
- Neurotransmitter Receptor Influence on Behavior
- Opioid Use Disorder Treatment
- Blood Pressure and Hypertension Studies
- Pharmacogenetics and Drug Metabolism
- Drug Transport and Resistance Mechanisms
- Alcohol Consumption and Health Effects
- Cholinesterase and Neurodegenerative Diseases
- Nicotinic Acetylcholine Receptors Study
- Fibromyalgia and Chronic Fatigue Syndrome Research
Biohaven Pharmaceuticals (United States)
2019-2025
Pfizer (United States)
2023
John Wiley & Sons (United States)
2023
Hudson Institute
2023
New England Institute for Neurology and Headache
2020
California Medical Clinic for Headache
2020
Albert Einstein College of Medicine
2020
American Headache Society
2020
New York Proton Center
2020
Bristol-Myers Squibb (United States)
2006-2012
Calcitonin gene-related peptide receptor has been implicated in the pathogenesis of migraine. Rimegepant is an orally administered, small-molecule, calcitonin antagonist that may be effective acute migraine treatment.In a multicenter, double-blind, phase 3 trial, we randomly assigned adults with at least 1-year history and two to eight attacks moderate or severe intensity per month receive rimegepant dose 75 mg matching placebo for treatment single attack. The primary end points were freedom...
Abstract Background Rimegepant orally disintegrating tablet (ODT), an oral small-molecule calcitonin gene-related peptide receptor antagonist, is indicated for acute and preventive treatment of migraine in the United States other countries. Previously, a large clinical trial assessed efficacy safety rimegepant ODT 75 mg adults living China or South Korea. A post hoc subgroup analysis this was performed to evaluate China. Methods Eligible participants were ≥ 18 years age had 1-year history...
The opioid antagonist, naltrexone, is reported, in single centre studies, to improve the clinical outcome of individuals with alcohol dependence participating outpatient psychosocial programmes. This first multicentre controlled study evaluate efficacy and safety naltrexone as adjunctive treatment for or abuse. Patients who met criteria (n = 169) abuse 6) were randomly assigned receive double-blind oral 50 mg daily 90) placebo 85) 12 weeks an adjunct treatment. primary variable was time...
<h3>Background:</h3> Naltrexone hydrochloride is the first medication approved in United States for treatment of alcohol dependence almost 50 years. This study was designed to collect safety data a setting that reflected expected clinical use naltrexone. <h3>Methods:</h3> 12-week, nonrandomized, open-label usage conducted 40 alcoholism centers throughout States, including free-standing programs, university clinics, Veterans Administration hospitals, and office-based primary care practices....
Objective Evaluate the safety and tolerability of oral rimegepant when used for acute treatment concomitantly with a monoclonal antibody (mAb) targeting calcitonin gene‐related peptide (CGRP) ligand or receptor (CGRP mAb) preventive migraine. Background The efficacy CGRP mAbs migraine small molecule antagonist has been demonstrated in randomized controlled clinical trials. Over past few years, US Food Drug Administration approved 4 2 antagonists A previous case report patients receiving...
Abstract Objective Evaluate the efficacy, safety, and tolerability of zavegepant nasal spray in acute treatment migraine. Background Calcitonin gene‐related peptide‐targeting agents are a novel class therapeutics for migraine, but none currently available as nonoral option treatment. Zavegepant, high‐affinity, selective, structurally unique calcitonin peptide‐receptor antagonist late‐stage development, is formulated Methods This randomized, dose‐ranging, placebo‐controlled, Phase 2/3 trial...
This post-hoc analysis from three phase 3 treatment trials of rimegepant 75 mg - an oral small molecule calcitonin gene-related peptide receptor antagonist for acute and preventive migraine assessed efficacy in adults with based on triptan experience.Participants were assigned to one four groups experience: insufficient response (e.g. lack and/or poor tolerability) 1 triptan, ≥2 triptans, current users, triptan-naïve participants. The co-primary endpoints pain freedom most bothersome symptom...
The present study evaluated the long-term safety and tolerability of rimegepant, an orally administered small molecule calcitonin gene-related peptide receptor antagonist, in people with migraine.
In a placebo-controlled, double-blind German multicenter study (seven sites) the efficacy of naltrexone as an adjunctive treatment in alcoholism to maintain abstinence was assessed for 12 weeks. A total 171 detoxified patients (97.7% met DSM-III-R criteria alcohol dependence) were included. Patients had been abstinent mean 19.5 ± 9.4 days at entry. Eighty-four and 87 randomized receive (50 mg/day) placebo, respectively. Each site instructed provide its usual psychosocial program. The primary...
Corticotropin releasing factor (CRF), a mediator of stress response, alters gastrointestinal (GI) functions. Stress-related changes in colonic motility are blocked by selective CRF(1) receptor antagonists. Our aim was to assess whether modulation central and peripheral receptors affects transit bowel function female patients with diarrhea-predominant irritable syndrome (D-IBS). This randomized, double-blind, placebo-controlled, 2-wk study evaluated the effects oral pexacerfont (BMS-562086),...
<h3>Objective</h3> To provide the first clinical report that 2 calcitonin gene-related peptide (CGRP) therapies, a small molecule CGRP receptor antagonist and an anti-CGRP antibody, can be used concomitantly to treat refractory migraine. <h3>Methods</h3> Case reports are presented of patients participating in long-term safety study rimegepant 75 mg oral tablets for acute treatment (NCT03266588). After Food Drug Administration approval erenumab, both started subcutaneous erenumab monthly as...
This study compared the efficacy, tolerability, and safety of rimegepant 75 mg oral tablet - a small molecule calcitonin-gene receptor peptide (CGRP) antagonist with placebo in acute treatment migraine.
Background Rimegepant is an oral, small molecule calcitonin gene-related peptide receptor antagonist for acute treatment of migraine and prevention. Methods This was a single-site, placebo-controlled, sequential, single multiple ascending dose study in healthy males females, aged 18–55 years, with no clinically significant medical history. The objectives were to assess the safety, tolerability, pharmacokinetics oral capsule free-base formulation. Single doses rimegepant from 25–1500 mg...
Zavegepant is a novel gepant administered as nasal spray approved in the United States at 10 mg dose for acute treatment of migraine with or without aura adults. The cardiovascular safety zavegepant was assessed both single-ascending (SAD) and multiple-ascending (MAD) studies healthy participants. SAD study included 72 participants (54 active/18 placebo) who received 0.1-40 placebo. MAD (56 active/16 5-40 placebo 1-14 days. Plasma pharmacokinetics electrocardiographic (ECG) parameters...
Abstract Rimegepant (Nurtec ODT)—an orally administered, small‐molecule calcitonin gene–related peptide receptor antagonist indicated for the acute and preventive treatment of migraine—is a substrate both P‐glycoprotein breast cancer resistance protein transporters in vitro. We evaluated effects concomitant administration strong inhibitors these on pharmacokinetics rimegepant healthy subjects. This single‐center, open‐label, randomized study was conducted 2 parts, which were 2‐period,...
Objective: Investigate whether rimegepant-an oral small molecule calcitonin gene-related peptide receptor antagonist for the treatment of migraine-is excreted in human milk after a single 75 mg dose and characterize its concentration-time profile plasma healthy lactating women to determine relative infant (RID). Methods: This open-label, single-center study enrolled aged 18-40 years with gestation 37-42 weeks uncomplicated delivery child ≥2 (14 days) ≤6 months before drug administration....
Background Rimegepant is an orally administered small molecule calcitonin gene-related peptide receptor antagonist indicated for the acute and preventive treatment of migraine. Methods Two single-center, phase 1, open-label, randomized bioequivalence studies were conducted in healthy adult non-smokers, aged 18–55 years. One study compared rate extent absorption marketed formulation rimegepant 75 mg disintegrating tablet (ODT) sublingually with oral tablet, earlier development formulation;...
A single-center, phase I, partially double-blind (double-blind regarding doses of rimegepant and placebo, open label with respect to moxifloxacin), randomized, 12-sequence, four-period crossover study therapeutic (75 mg) supratherapeutic (300 placebo moxifloxacin (400 controls was designed evaluate drug effect on the Fridericia corrected QT (QTcF) interval in healthy fasted adults. total 38 participants were randomized dosed study. Electrocardiogram (ECG) data available from 37 75-mg group,...