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Effects of Gocovri (Amantadine) Extended Release Capsules on Non-Motor Symptoms in Patients with Parkinson's Disease and Dyskinesia.
| Content Provider | Europe PMC |
|---|---|
| Author | Mehta, Shyamal H. Pahwa, Rajesh Tanner, Caroline M. Hauser, Robert A. Johnson, Reed |
| Abstract | IntroductionGocovri (amantadine) extended release capsules are approved for treatment of dyskinesia and as a levodopa adjunct for OFF episodes in patients with Parkinson’s disease (PD). We report treatment-related effects on non-motor symptoms (NMS) assessed as secondary outcomes in two trials using the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part I.MethodsEASE LID and EASE LID 3 enrolled levodopa-treated patients with PD and ≥ 1 h/day ON time with troublesome dyskinesia. Patients were randomized to Gocovri (274 mg) or placebo taken daily at bedtime. Treatment differences from baseline to week 12 in MDS-UPDRS Part I were evaluated for the pooled population (N = 196) from both trials. Correlation analyses of NMS (MDS-UPDRS Part I) with dyskinesia using Unified Dyskinesia Rating Scale (UDysRS) scores were performed.ResultsFor changes in the MDS-UPDRS Part I items, the treatment difference favored Gocovri in daytime sleepiness (P = 0.006) and depression (P = 0.049) scores, but favored placebo in cognitive impairment (P = 0.038), and hallucinations and psychosis (P < 0.001) scores. The treatment difference for the changes in total Part I score was −0.8, favoring Gocovri (P = 0.22). At baseline, MDS-UPDRS Part I modestly correlated with UDysRS score (r +0.25, P < 0.001), and improvement in NMS correlated with improvement in dyskinesia at week 12 for Gocovri (r +0.39, P < 0.001) but not placebo (r +0.12, P = 0.29). The most commonly reported adverse events for Gocovri were hallucination (21%); dizziness, dry mouth, and peripheral edema (16% each); and constipation, falls, and orthostatic hypotension (13% each).ConclusionThis post hoc analysis shows potential benefit with Gocovri treatment for the NMS of daytime sleepiness and depression in dyskinetic PD patients. Overall, improvement in NMS scores correlated with improvement in dyskinesia.Trial RegistrationClinicalTrials.gov identifiers: NCT02136914 and NCT02274766 |
| Related Links | https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC8140024&blobtype=pdf |
| ISSN | 21938253 |
| Journal | Neurology and Therapy [Neurol Ther] |
| Volume Number | 10 |
| DOI | 10.1007/s40120-021-00246-3 |
| PubMed Central reference number | PMC8140024 |
| Issue Number | 1 |
| PubMed reference number | 33864229 |
| e-ISSN | 21936536 |
| Language | English |
| Publisher | Springer Healthcare |
| Publisher Date | 2021-04-17 |
| Publisher Place | Cheshire |
| Access Restriction | Open |
| Rights License | Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/. © The Author(s) 2021 |
| Subject Keyword | Amantadine Depression Depressive disorder Dyskinesias Hallucinations Parkinson’s disease Sleep |
| Content Type | Text |
| Resource Type | Article |
| Subject | Neurology Neurology (clinical) |
