ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson’s Disease (EASE LID 2 Study): Interim Results of an Open-Label Safety Study

Autor: Robert A. Hauser, Mary Jean Stempien, Rajesh Pahwa, Caroline M. Tanner, Reed Johnson, Wolfgang H. Oertel, Larissa Felt, Stuart Isaacson
Rok vydání: 2017
Předmět:
Research Report
Male
0301 basic medicine
Dyskinesia
Drug-Induced
Parkinson's disease
Peripheral edema
Kaplan-Meier Estimate
Neurodegenerative
Levodopa
Drug Delivery Systems
0302 clinical medicine
Medicine
Rehabilitation
levodopa-induced dyskinesia
Middle Aged
Treatment Outcome
Tolerability
6.1 Pharmaceuticals
Anesthesia
Neurological
Female
medicine.symptom
Clinical Trials and Supportive Activities
Placebo
Bedtime
03 medical and health sciences
Cellular and Molecular Neuroscience
Double-Blind Method
Clinical Research
Amantadine
Humans
Adverse effect
Aged
amantadine
Levodopa-induced dyskinesia
Dyskinesia
business.industry
Neurosciences
Evaluation of treatments and therapeutic interventions
Interim analysis
Brain Disorders
dyskinesia
030104 developmental biology
Drug-Induced
Parkinson’s disease
Biochemistry and Cell Biology
Neurology (clinical)
business
030217 neurology & neurosurgery
Zdroj: Journal of Parkinson's disease, vol 7, iss 3
Journal of Parkinson's Disease
ISSN: 1877-718X
1877-7171
DOI: 10.3233/jpd-171134
Popis: Author(s): Hauser, Robert A; Pahwa, Rajesh; Tanner, Caroline M; Oertel, Wolfgang; Isaacson, Stuart H; Johnson, Reed; Felt, Larissa; Stempien, Mary Jean | Abstract: BackgroundMedical treatment of levodopa-induced dyskinesia (LID) in Parkinson's disease (PD) is an unmet need. ADS-5102 (amantadine) extended-release capsules is being developed for the treatment of LID in patients with PD.ObjectiveEvaluate the long-term safety and tolerability of 274 mg ADS-5102 for LID in PD.MethodsIn an ongoing, open-label safety study (NCT02202551), PD patients with LID received 274 mg of ADS-5102 once daily at bedtime. Patients were recruited from previous ADS-5102 trials. In addition, patients were enrolled who were ineligible for previous ADS-5102 trials due to previous implantation of deep-brain stimulation (DBS) devices. The primary outcome measure was safety assessed through adverse events (AEs). Efficacy was assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part IV and its subparts.ResultsFor this interim analysis, 223 patients received ADS-5102 for a mean duration of 348 (SD 182) days. The most common AEs included falls (25.1%), visual hallucinations (19.3%), peripheral edema (13.0%), and constipation (12.6%). Overall, 32 patients (14.3%) discontinued due to an AE. In patients receiving placebo in previous studies, the mean MDS-UPDRS, Part IV scores decreased by 3.4 points from baseline (n = 78) to week 8 and remained stable through week 64 (n = 21). In patients receiving ADS-5102 in previous studies, the mean baseline (n = 61) MDS-UPDRS, Part IV score was low due to the response to ADS-5102 in previous studies and remained stable through week 64 (total of 88 weeks; n = 21). The effect was primarily due to reduction in item 4.2 (functional impact of dyskinesia) and item 4.4 (functional impact of motor fluctuations).ConclusionsADS-5102 was generally well tolerated in all groups, including DBS patients, and the safety profile was consistent with previous controlled studies. Long-term durability and tolerability were shown from the double-blind studies through participation in the open-label study up to 88 weeks.
Databáze: OpenAIRE
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