https://doi.org/10.55788/7a8928c2
The 3-year results of the BeyoND study (NCT02726386) were presented by Dr Aaron Ellenbogen (Michigan Institute for Neurological Disorders, MI, USA) [1]. This open-label, phase 2 study evaluated the long-term safety of ND0612 in participants with PD who experienced ≥2 hours of daily OFF-time. The results confirmed the previously published positive outcomes after 1 year, comprising data from 214 participants, 120 of whom completed 1 year, and 114 participants entered the extension study [2]. Dr Ellenbogen highlighted that 94 participants (82.5%) completed ≥2 years and 76 (80.1%) completed ≥3 years of ND0612 treatment; some participants were already in their 7th year. Of the 20 discontinuing participants, 10 withdrew consent and 4 experienced intolerable side effects (AEs).
At baseline, participants who entered the extension phase had a mean (± SD) OFF-time of 5.6 (± 2.9) hours and a mean Unified Parkinson’s Disease Rating Scale (UPDRS) motor score of 26.1 (±12.8). Further, 57 (50%) participants presented with a modified Hoehn and Yahr Scale score of 2, as opposed to 27 (23.7%) participants with a score of 2.5 and 30 (26.3%) participants with a score of 3. Dr Ellenbogen said the systemic safety profile was comparable with the expected profiles for a levodopa/carbidopa product. In year 1 of the extension period, 73.7% of the 114 participants showed drug-related AEs. In year 2, this percentage dropped to 36.9% of 111 participants and 39.4% of 94 participants in year 3. Infusion site reactions were common, mostly mild, and rarely led to discontinuation. These reactions also decreased over time (60.5% of participants in year 1, 26.1% in year 2, and 27.7% in year 3). The incidence of infusion-site infection shifted from 19.3% in year 1 to 9.9% in year 2, and 11.7% in year 3. Dyskinesia was seen in 3.5% of participants in year 1, none in year 2, and 1.1% in year 3.
Exploratory efficacy results in 45 participants at month 36 showed a mean reduction in OFF-time of -2.81 hours. The increase in Good ON-time was 2.79 hours.
- Ellenbogen AL, et al. Safety and efficacy of continuous subcutaneous levodopa/carbidopa infusion for Parkinson's disease. Three-year data from the open-label BeyoND study. PL4.003, AAN 2023 Annual Meeting, 22–27 April, Boston, USA.
- Poewe W, et al. Mov Disord. 2021;36(11):2687–92.
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Table of Contents: AAN 2023
Featured articles
Letter from the Editor
Positive results for hereditary transthyretin-mediated amyloid polyneuropathy
Infectious Diseases
Allogenic T-cell-based immunotherapy for PML in development
Cognitive Impairment and Dementia
Lecanemab may slow decline of cognition and function in Alzheimer’s Disease
Donanemab shows rapid and deep plaque clearance in early Alzheimer’s Disease
Epilepsy
Seizure forecasting and detection with wearable devices are feasible
Encouraging first results of GABAergic interneurons implants for focal epilepsy
Headache and Migraine
Lecture on migraine: from the prodromal phase to future paradigm shifts
Zavegepant nasal spray exhibits good efficacy and safety in acute migraine
A vaccine as a potentially safe and effective immunotherapy against CGRP
Multiple Sclerosis
Teriflunomide prevents conversion to MS in patients with RIS
Gold nanocrystals may be effective as adjunctive MS therapy
Muscle and Neuro-Muscular Disorders
First-ever ALS platform trial reports on outcomes of 4 treatments
Pridopidine for Huntington’s disease fails to meet the primary endpoint
Parkinson's Disease
Continuous levodopa/carbidopa infusion shows favourable safety and efficacy
Unilateral right STN-DBS improves verbal fluency
Stroke
Harnessing the microbiome as a possible stroke treatment
Patients with a large core infarct benefit from thrombectomy
Miscellaneous
Artificial intelligence applications in neurology: seize the moment
Spinal cord stimulation eases painful diabetic neuropathy
EVT improves functional outcomes in Chinese patients with BAO
Severe sleep apnoea associated with white matter hyperintensities
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