Trial reportClinical pharmacokinetics2019
Pharmacokinetics of ADS-5102 (Amantadine) Extended Release Capsules Administered Once Daily at Bedtime for the Treatment of Dyskinesia.
Trial report in Clinical pharmacokinetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 44 citations in OpenAlex.
- A Phase 3, double-blind, placebo-controlled efficacy and safety study of ADS-5102 (Amantadine) extended-release capsules in people with multiple sclerosis and walking impairment.Multiple sclerosis (Houndmills, Basingstoke, England) · 2022Trial
- EASE LID 2: A 2-Year Open-Label Trial of Gocovri (Amantadine) Extended Release for Dyskinesia in Parkinson's Disease.Journal of Parkinson's disease · 2020Trial
- Prevalence of Dyskinesia and OFF by 30-Minute Intervals Through the Day and Assessment of Daily Episodes of Dyskinesia and OFF: Novel Analyses of Diary Data from Gocovri Pivotal Trials.Journal of Parkinson's disease · 2019Trial
- Cutting-edge treatments in amyotrophic lateral sclerosis: the role of molecular pathogenesis in targeted therapies.Stem cell research & therapy · 2025Review
- Moving to a non-dopaminergic approach for the treatment of OFF fluctuations in Parkinson's disease.Clinical parkinsonism & related disorders · 2025Review
- Efficacy and safety of oral amantadine in Parkinson's disease with dyskinesia and motor fluctuations: a systematic review and meta-analysis of randomised controlled trials.BMJ neurology open · 2025Article
- Drug resistance and possible therapeutic options against influenza A virus infection over past years.Archives of microbiology · 2024Review
- Association of depression with disease duration, quality of life and adherence in Parkinson's disease: A cross sectional study.Journal of family medicine and primary care · 2023Article
- The convergent evolution of influenza A virus: Implications, therapeutic strategies and what we need to know.Current research in microbial sciences · 2023Article
- An Update on Nondopaminergic Treatments for Motor and Non-motor Symptoms of Parkinson's Disease.Current neuropharmacology · 2023Review
- Amantadine delayed release/extended release capsules significantly reduce OFF time in Parkinson's disease.NPJ Parkinson's disease · 2022Article
- Antiviral Drugs in Influenza.International journal of environmental research and public health · 2022Review
- Effects of Gocovri (Amantadine) Extended-Release Capsules on Motor Aspects of Experiences of Daily Living in People with Parkinson's Disease and Dyskinesia.Neurology and therapy · 2021Article
- An Update on Medical and Surgical Treatments of Parkinson's Disease.Aging and disease · 2021Review
- Effects of Gocovri (Amantadine) Extended Release Capsules on Non-Motor Symptoms in Patients with Parkinson's Disease and Dyskinesia.Neurology and therapy · 2021Article
- Amantadine: reappraisal of the timeless diamond-target updates and novel therapeutic potentials.Journal of neural transmission (Vienna, Austria : 1996) · 2021Review
- Therapeutic Strategies to Treat or Prevent Off Episodes in Adults with Parkinson's Disease.Drugs · 2020Review
- Amantadine Alleviates Postoperative Cognitive Dysfunction Possibly by Preserving Neurotrophic Factor Expression and Dendritic Arborization in the Hippocampus of Old Rodents.Frontiers in aging neuroscience · 2020Article
- Article
- Amantadine Combines Astroglial System XcBiomolecules · 2019Article
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPreclinical and clinical studies suggest amantadine immediate-release (IR) may reduce dyskinesia in Parkinson's disease (PD), although higher doses are associated with increased CNS adverse events (AEs). ADS-5102 is an extended release amantadine capsule formulation, designed for once-daily dosing at bedtime (qhs) to provide high concentrations upon waking and throughout the day, with lower concentrations in the evening. The pharmacokinetics (PK) of ADS-5102 were assessed in two phase I studies in healthy subjects, and a blinded, randomized phase II/III dose-finding study in PD patients.
methodsThe first phase I study assessed single ADS-5102 doses (68.5, 137, and 274 mg) in a crossover design, whereas the second phase I study evaluated ADS-5102 137 mg for 7 days followed by amantadine IR 81 mg twice daily (or reverse order). In the phase II/III double-blind study, PD patients with dyskinesia were randomized to ADS-5102 (210, 274, or 338 mg) or placebo for 8 weeks.
resultsSingle ADS-5102 doses resulted in a slow initial rise in amantadine plasma concentration, with delayed time to maximum concentration (12-16 h). Amantadine plasma concentrations were higher in PD patients versus healthy volunteers. The steady-state profile of once-daily ADS-5102 was significantly different from that of twice-daily amantadine IR, such that the two formulations are not bioequivalent. PK modeling suggested the recommended daily ADS-5102 dosage (274 mg qhs) resulted in 1.4- to 2.0-fold higher amantadine plasma concentrations during the day versus amantadine IR.
conclusionsADS-5102 can be administered once-daily qhs to achieve high amantadine plasma concentrations in the morning and throughout the day, when symptoms of dyskinesia occur.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.