دورية أكاديمية

Parkinson's Patients with Dyskinesia Switched from Immediate Release Amantadine to Open‐label ADS‐5102

التفاصيل البيبلوغرافية
العنوان: Parkinson's Patients with Dyskinesia Switched from Immediate Release Amantadine to Open‐label ADS‐5102
المؤلفون: Isaacson, Stuart H, Fahn, Stanley, Pahwa, Rajesh, Tanner, Caroline M, Espay, Alberto J, Trenkwalder, Claudia, Adler, Charles H, Patni, Rajiv, Johnson, Reed
المصدر: Movement Disorders Clinical Practice, vol 5, iss 2
بيانات النشر: eScholarship, University of California
سنة النشر: 2018
المجموعة: University of California: eScholarship
مصطلحات موضوعية: Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Clinical Sciences, Brain Disorders, Clinical Research, Parkinson's Disease, Aging, Neurodegenerative, Clinical Trials and Supportive Activities, Neurosciences, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Neurological, dyskinesia, amantadine, levodopa-induced, levodopa‐induced
جغرافية الموضوع: 183 - 190
الوصف: BackgroundADS-5102 (amantadine) extended release capsules (GOCOVRI™) are a treatment for dyskinesia in patients with Parkinson's disease (PD). ADS-5102 reduced dyskinesia and OFF time in phase 3 controlled trials of up to six months. Amantadine immediate release (IR) is used for dyskinesia, but suboptimal durability and tolerability limit its clinical utility.MethodsIn an ongoing, open-label, phase 3 study in the US and Western Europe (NCT02202551), patients with PD received 274 mg of ADS-5102 (equivalent to 340 mg amantadine HCl) once daily at bedtime for up to two years. Study outcomes included safety and assessment of motor complications, as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV. This manuscript focuses on those patients switched to ADS-5102 from amantadine IR. Results in two groups of patients who previously completed a randomized controlled trial (EASE LID or EASE LID 3) are also presented according to use of ADS-5102 or placebo in that study before enrollment in the open-label study.ResultsChange in MDS-UPDRS Part IV at week 8 was -0.3 in the previous ADS-5102 subgroup (n = 61), -3.4 in the previous placebo subgroup (n = 79), and -3.4 in the previous amantadine IR subgroup (n = 32). Effects were maintained to week 64. In the previous amantadine IR subgroup (mean treatment duration, 2.5 years), mean amantadine IR dose was 221 mg. Safety data were consistent with previous randomized controlled trials of ADS-5102.ConclusionThese open-label data suggest ADS-5102 provides incremental reduction from baseline in MDS-UDPRS Part IV score in patients switched directly from amantadine IR, without exacerbating adverse events.
نوع الوثيقة: article in journal/newspaper
وصف الملف: application/pdf
اللغة: unknown
العلاقة: qt9gj5p809; https://escholarship.org/uc/item/9gj5p809Test
الإتاحة: https://escholarship.org/uc/item/9gj5p809Test
حقوق: public
رقم الانضمام: edsbas.F7CFED5B
قاعدة البيانات: BASE