FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4367303982> ?p ?o ?g. }

• W4367303982 abstract "<h3>Objective:</h3> Evaluate the efficacy and safety of P2B001 compared with Extended-Release pramipexole (Prami-ER) in untreated Parkinson’s disease (PD). <h3>Background:</h3> P2B001 is an investigational, fixed low-dose, once-daily combination of ER formulations of pramipexole and rasagiline (0.6/0.75mg). We have previously reported that P2B001 provided significantly superior symptomatic efficacy compared to each of its components (primary efficacy endpoint). Here we report exploratory findings of P2B001 versus Prami-ER which was titrated for optimal efficacy and tolerability. <h3>Design/Methods:</h3> This was an international, multicenter, randomized, double-blind, parallel-group study in patients with early untreated PD comparing once-daily P2B001 to its individual components and to optimally titrated Prami-ER (mean dose of 3.2mg). Eligible patients were aged 35–80y, <3 years from PD diagnosis, and not receiving anti-parkinsonian therapy. Exploratory endpoints are presented along with nominal p-values. <h3>Results:</h3> Changes from baseline to week 12 in total UPDRS (Part II+III) scores between P2B001 and Prami-ER were not significantly different (−8.35 ±0.86 vs 7.98 ±0.6); <i>post-hoc</i> analysis confirmed non-inferiority of P2B001 to Prami-ER (margin of 3 points, p=0.0052). Likewise, there were no significant differences between P2B001 and Prami-ER on UPDRS Part II (activities of daily living) or Part III (motor) scores. Overall, 74.1% of patients receiving P2B001 and 76.6% of patients receiving Prami-ER showed ≥4-point improvement in UPDRS Total scores (Odds ratio 0.87 [0.44, 1.75]; p=0.70). Overall, 74.7% of patients experienced ≥1 TEAE with P2B001 versus 86.5% with titrated Prami-ER and there was a lower frequency of dopaminergic-related TEAEs (44.7% versus 66.2%, respectively). Rates of somnolence (14.7% versus 31.1%) and orthostatic hypotension (2.7% versus 12.2%) were also lower with P2B001 compared with Prami-ER. <h3>Conclusions:</h3> These data indicate that P2B001 offers a once daily treatment option (without the need for titration) for patients with early PD with comparable efficacy to marketed Prami-ER but with reduced sleep-related and dopaminergic side effects. <b>Disclosure:</b> Dr. Elmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Acadia Pharmaceuticals. Dr. Elmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Acorda Therapeutics. Dr. Elmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal Pharmaceuticals. Dr. Elmer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva Pharmaceuticals. The institution of Dr. Elmer has received research support from Vaccinex, Inc.. The institution of Dr. Elmer has received research support from Cynapsus Therapeutics, Inc.. The institution of Dr. Elmer has received research support from Lundbeck Pharmaceuticals, Inc.. The institution of Dr. Elmer has received research support from Intec Pharmaceuticals, Inc.. The institution of Dr. Elmer has received research support from Pharma Two B. The institution of Dr. Elmer has received research support from Acadia Pharmaceuticals, Inc.. The institution of Dr. Elmer has received research support from Impax Laboratories, LLC. The institution of Dr. Elmer has received research support from Prilenia Therapeutics. The institution of Dr. Elmer has received research support from Neuraly, Inc.. Dr. Litman has received personal compensation for serving as an employee of PHARMA 2B. Mrs. Friedman has received personal compensation for serving as an employee of Pharma Two B. Dr. Fitzer-Attas has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma America. The institution of Dr. Fitzer-Attas has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Cyclerion. The institution of Dr. Fitzer-Attas has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Pharma Two B. The institution of Dr. Fitzer-Attas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Golden Heart Flower. The institution of Dr. Fitzer-Attas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for B-Portal Biologics. Dr. Fitzer-Attas has stock in Golden Heart Flower. Sheila Oren, MD, MBA has received personal compensation for serving as an employee of Neuroderm. Sheila Oren, MD, MBA has received personal compensation in the range of $0-$499 for serving as a Consultant for Neuroderm." @default.
• W4367303982 created "2023-04-29" @default.
• W4367303982 creator A5012965297 @default.
• W4367303982 creator A5028592744 @default.
• W4367303982 creator A5049671447 @default.
• W4367303982 creator A5051418285 @default.
• W4367303982 creator A5081208955 @default.
• W4367303982 date "2023-04-25" @default.
• W4367303982 modified "2023-10-14" @default.
• W4367303982 title "P2B001 (low dose combination of extended-release pramipexole and rasagiline) versus titrated extended-release pramipexole in the management of early Parkinson’s disease: Exploratory findings from a randomized, controlled trial (S32.010)" @default.
• W4367303982 doi "https://doi.org/10.1212/wnl.0000000000203489" @default.
• W4367303982 hasPublicationYear "2023" @default.
• W4367303982 type Work @default.
• W4367303982 citedByCount "0" @default.
• W4367303982 crossrefType "proceedings-article" @default.
• W4367303982 hasAuthorship W4367303982A5012965297 @default.
• W4367303982 hasAuthorship W4367303982A5028592744 @default.
• W4367303982 hasAuthorship W4367303982A5049671447 @default.
• W4367303982 hasAuthorship W4367303982A5051418285 @default.
• W4367303982 hasAuthorship W4367303982A5081208955 @default.
• W4367303982 hasConcept C126322002 @default.
• W4367303982 hasConcept C168563851 @default.
• W4367303982 hasConcept C197934379 @default.
• W4367303982 hasConcept C203092338 @default.
• W4367303982 hasConcept C2778375690 @default.
• W4367303982 hasConcept C2779134260 @default.
• W4367303982 hasConcept C2779734285 @default.
• W4367303982 hasConcept C2779989193 @default.
• W4367303982 hasConcept C2781249495 @default.
• W4367303982 hasConcept C3020385749 @default.
• W4367303982 hasConcept C67761136 @default.
• W4367303982 hasConcept C71924100 @default.
• W4367303982 hasConcept C98274493 @default.
• W4367303982 hasConceptScore W4367303982C126322002 @default.
• W4367303982 hasConceptScore W4367303982C168563851 @default.
• W4367303982 hasConceptScore W4367303982C197934379 @default.
• W4367303982 hasConceptScore W4367303982C203092338 @default.
• W4367303982 hasConceptScore W4367303982C2778375690 @default.
• W4367303982 hasConceptScore W4367303982C2779134260 @default.
• W4367303982 hasConceptScore W4367303982C2779734285 @default.
• W4367303982 hasConceptScore W4367303982C2779989193 @default.
• W4367303982 hasConceptScore W4367303982C2781249495 @default.
• W4367303982 hasConceptScore W4367303982C3020385749 @default.
• W4367303982 hasConceptScore W4367303982C67761136 @default.
• W4367303982 hasConceptScore W4367303982C71924100 @default.
• W4367303982 hasConceptScore W4367303982C98274493 @default.
• W4367303982 hasLocation W43673039821 @default.
• W4367303982 hasOpenAccess W4367303982 @default.
• W4367303982 hasPrimaryLocation W43673039821 @default.
• W4367303982 hasRelatedWork W1970082233 @default.
• W4367303982 hasRelatedWork W2005603178 @default.
• W4367303982 hasRelatedWork W2057733580 @default.
• W4367303982 hasRelatedWork W2074926250 @default.
• W4367303982 hasRelatedWork W2142359920 @default.
• W4367303982 hasRelatedWork W2185282305 @default.
• W4367303982 hasRelatedWork W2386495541 @default.
• W4367303982 hasRelatedWork W2405623111 @default.
• W4367303982 hasRelatedWork W2604132220 @default.
• W4367303982 hasRelatedWork W4221036987 @default.
• W4367303982 isParatext "false" @default.
• W4367303982 isRetracted "false" @default.
• W4367303982 workType "article" @default.