Session Information
Date: Thursday, June 8, 2017
Session Title: Parkinson’s Disease: Clinical Trials, Pharmacology And Treatment
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
Objective: To review symptomatic therapy (ST) utilization trends in individuals with early Parkinson’s disease (PD).
Background: There are changing trends in ST utilization in early PD. Here, we present an interim analysis of the ST utilization characteristics in individuals with early PD at baseline, enrolled in a phase 3 disease modification clinical trial.
Methods: STEADY-PD III is an ongoing multicenter, phase 3, randomized, double-blind, placebo-controlled trial assessing the disease modifying effects of isradipine 10mg daily. The study population includes individuals with de novo PD, not treated with ST except stable doses of anticholinergics or amantadine at the time of enrollment. A secondary endpoint of the study is time to initiation of ST.
Results: 336 subjects were enrolled in a 36 month study, and 330 are currently active. Recruitment was concluded within 11 months. There have been 6 premature withdrawals and 223 (67.5%) subjects have initiated ST as of Dec 2016. 19% of all active subjects (330) were on ST by 3 months from baseline and 38% by 6 months. 43 % of the enrolled subjects are using Carbidopa/Levodopa, 20% MAO-Inhibitors, 19% Dopamine agonists and 13% are on other PD medications. 68% of ST users are on monotherapy and 25% are taking a combination of two different drug classes. The most common drug combination used by those on ST (223) are Carbidopa/Levodopa with a MAO-inhibitor (5.8%), and MAO-Inhibitor with a dopamine agonist (5.3%).
Conclusions: The de novo PD cohort enrolled in STEADY-PD III has earlier ST initiation compared to the previous disease modifying studies. This might be a reflection of the study design with its less stringent criteria for use of ST or the general trend for earlier ST initiation. Carbidopa/levodopa is the most commonly used ST. Secondary analyses will evaluate the impact of isradipine on ST initiation and take into account levodopa equivalents when assessing the primary outcome.
To cite this abstract in AMA style:
S. Sharma, T. Simuni, B. Greco, K. Biglan, C. Tarolli, K. Hodgeman, D. Oakes, D. Penz. Drug utilization characteristics in individuals with early Parkinson’s disease interim analysis of the STEADY-PD III study [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/drug-utilization-characteristics-in-individuals-with-early-parkinsons-disease-interim-analysis-of-the-steady-pd-iii-study/. Accessed May 21, 2025.« Back to 2017 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/drug-utilization-characteristics-in-individuals-with-early-parkinsons-disease-interim-analysis-of-the-steady-pd-iii-study/