Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial
Sign Up to like & getrecommendations! Published in 2017 at "JAMA Neurology"
DOI: 10.1001/jamaneurol.2016.4703
Abstract: Importance Catechol O-methyltransferase (COMT) inhibitors are an established treatment for end-of-dose motor fluctuations associated with levodopa therapy in patients with Parkinson disease (PD). Current COMT inhibitors carry a high risk for toxic effects to hepatic… read more here.
Keywords: phase; opicapone; treatment; time ... See more keywords
Investigating Potential Bias in Patient-Reported Outcomes in Open-label Cancer Trials.
Sign Up to like & getrecommendations! Published in 2019 at "JAMA oncology"
DOI: 10.1001/jamaoncol.2018.6205
Abstract: Recent legislative efforts such as the 21st Century Cures Act have emphasized capturing and communicating the patient experience. Patient-reported outcome (PRO) assessments are one method to measure symptoms, function, and health-related quality of life. In… read more here.
Keywords: open label; cancer trials; cancer; patient reported ... See more keywords
Levetiracetam as a sensitizer of concurrent chemoradiotherapy in newly diagnosed glioblastoma: An open‐label phase 2 study
Sign Up to like & getrecommendations! Published in 2021 at "Cancer Medicine"
DOI: 10.1002/cam4.4454
Abstract: An open‐label single‐arm phase 2 study was conducted to evaluate the role of levetiracetam as a sensitizer of concurrent chemoradiotherapy (CCRT) for patients with newly diagnosed glioblastoma. This study aimed to determine the survival benefit… read more here.
Keywords: study; levetiracetam sensitizer; glioblastoma; sensitizer concurrent ... See more keywords
Effect of Roxadustat on the Pharmacokinetics of Simvastatin, Rosuvastatin, and Atorvastatin in Healthy Subjects: Results From 3 Phase 1, Open‐Label, 1‐Sequence, Crossover Studies
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1076
Abstract: Roxadustat inhibits breast cancer resistance protein and organic anion transporting polypeptide 1B1, which can affect coadministered statin concentrations. Three open‐label, 1‐sequence crossover phase 1 studies in healthy subjects were conducted to assess effects from steady‐state… read more here.
Keywords: roxadustat; label sequence; sequence crossover; atorvastatin ... See more keywords
Pharmacokinetics and Bioequivalence of 2 Azithromycin Tablet Formulations: A Randomized, Open‐Label, 2‐Stage Crossover Study in Healthy Volunteers
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1098
Abstract: The current study aimed to assess the bioequivalence of a new branded azithromycin with the reference formulation. An open‐label, randomized, 2‐stage, crossover study design was implemented involving 77 healthy volunteers under fasting conditions. Each volunteer… read more here.
Keywords: reference; crossover study; bioequivalence; open label ... See more keywords
Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1, Open-Label, Single-Dose, Parallel-Group Study.
Sign Up to like & getrecommendations! Published in 2023 at "Clinical pharmacology in drug development"
DOI: 10.1002/cpdd.1244
Abstract: Rimegepant is a small-molecule calcitonin gene-related peptide receptor antagonist (gepant) with demonstrated efficacy and safety in the acute and preventive treatment of migraine. Here, we report the pharmacokinetics and safety of a single 75-mg oral… read more here.
Keywords: label single; rimegepant subjects; hepatic impairment; impairment ... See more keywords
A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study of Zanubrutinib with Rifabutin in Healthy Volunteers.
Sign Up to like & getrecommendations! Published in 2023 at "Clinical pharmacology in drug development"
DOI: 10.1002/cpdd.1250
Abstract: Zanubrutinib is a second-generation Bruton tyrosine kinase inhibitor that is primarily metabolized by CYP3A enzymes. Previous drug-drug interaction (DDI) studies have demonstrated that co-administration of zanubrutinib with rifampin, a strong CYP3A inducer, reduces zanubrutinib plasma… read more here.
Keywords: open label; zanubrutinib; drug drug; phase open ... See more keywords
Long‐term open‐label perampanel: Generalized tonic–clonic seizures in idiopathic generalized epilepsy
Sign Up to like & getrecommendations! Published in 2022 at "Epilepsia Open"
DOI: 10.1002/epi4.12602
Abstract: Assess the longer‐term efficacy and safety of adjunctive perampanel (up to 12 mg/day) in patients aged ≥12 years with generalized tonic–clonic (GTC) seizures from the Open‐label Extension (OLEx) Phase of Study 332 to determine whether responses obtained… read more here.
Keywords: long term; generalized tonic; term; tonic clonic ... See more keywords
Maribavir Pharmacokinetics and Safety in Participants With Moderate Hepatic Impairment: A Phase 1, Open‐Label, Single‐Dose, Parallel Group Study
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Clinical Pharmacology"
DOI: 10.1002/jcph.2155
Abstract: Maribavir, an orally bioavailable antiviral, has shown superior activity against posttransplant cytomegalovirus infection compared with conventional antivirals. It is primarily metabolized in the liver. This open‐label, single‐center study evaluated the effect of hepatic impairment on… read more here.
Keywords: participants moderate; hepatic impairment; maribavir; impairment ... See more keywords
Budesonide orodispersible tablets for induction of remission in patients with active eosinophilic oesophagitis: A 6‐week open‐label trial of the EOS‐2 Programme
Sign Up to like & getrecommendations! Published in 2022 at "United European Gastroenterology Journal"
DOI: 10.1002/ueg2.12220
Abstract: Abstract Background A novel budesonide orodispersible tablet (BOT) has been proven effective in adult patients with active eosinophilic oesophagitis (EoE) in a 6‐week placebo‐controlled trial (EOS‐1). Aims To report the efficacy of an open‐label induction… read more here.
Keywords: histological remission; week; open label; trial ... See more keywords
Der Schein trügt nicht – klinische Evidenz und neue Forschungsansätze zum Open-label-Placebo
Sign Up to like & getrecommendations! Published in 2020 at "Der Nervenarzt"
DOI: 10.1007/s00115-020-00953-6
Abstract: Die Wirkung des Placeboeffekts ist seit mehreren Jahren in experimentellen, klinischen und metaanalytischen Studien belegt. Die bislang als notwendig erachtete Verschleierung der Wirkstofffreiheit einer Placeboanwendung stand bislang der einfachen klinischen Nutzung dieser positiven Effekte sowohl… read more here.
Keywords: die; label placebo; bislang; der ... See more keywords