Azathioprine immunosuppression and disease modification in Parkinson’s disease (AZA-PD): a randomised double-blind placebo-controlled phase II clinical trial
Objective: To design a clinical trial to test the concept that the immune system is integral in the progression of Parkinson’s disease (PD) and establish…Should Amantadine DR/ER Be Considered Prior to Device-Aided Therapies for Parkinson’s Disease?
Objective: Evaluate delayed release/extended release amantadine (AMT DR/ER) capsules for motor complications in patients meeting 5-2-1 criteria for device-aided therapies (DAT) in advanced Parkinson disease.…Effects of Opicapone on Sleep in Patients with Parkinson’s Disease and Motor Fluctuations
Objective: To assess the effects of opicapone (OPC: 50 mg, once-daily) on sleep in patients with Parkinson’s disease (PD) and motor fluctuations. Background: OPC is…Cinpanemab in Parkinson’s Disease: Imaging and Fluid Biomarker Results from the Phase 2 SPARK Study
Objective: To evaluate the effects of cinpanemab on biomarkers in participants with Parkinson’s disease (PD). Background: SPARK (NCT03318523) was designed to evaluate the safety, pharmacokinetics,…FIRST-IN-MAN CLINICAL TRIAL OF INTRAPUTAMENAL CDNF IN PARKINSON’S DISEASE FINDS A CONSORTED BIOMARKER RESPONSE IN A SUBGROUP OF SUBJECTS
Objective: In the first-in-man clinical study of intermittent intraputamenal monthly infusions of CDNF in subjects with moderately advanced PD, we explored cerebrospinal fluid (CSF) biomarkers…Evaluating Engagement of ABBV-0805, an Anti-Alpha-Synuclein Monoclonal Antibody to Physiological and Pathological Forms of Alpha-Synuclein for Phase 2 Dose Selection: A PBPK Modeling and Simulation Approach
Objective: To develop a physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) model to assist in the dose and dosing regimen selection of ABBV-0805 for Phase 2 studies. Background:…Randomized, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-0805, an Anti-Alpha-Synuclein Monoclonal Antibody in Healthy Subjects
Objective: To evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of ABBV-0805 following administration of single ascending doses of ABBV-0805, administered as intravenous (IV) infusions…Measuring progression of Parkinson’s disease cardinal signs in the Phase 2 SPARK study
Objective: To evaluate a novel quantitative measure of Parkinson’s disease (PD) severity and progression in a Phase II clinical trial. Background: Cinpanemab, a monoclonal antibody,…Apomorphine Sublingual Film for “OFF” Episodes in Parkinson’s Disease: Impact on Dyskinesia
Objective: Assess impact of apomorphine sublingual film (APL) on time spent with and functional impact of dyskinesia among patients with Parkinson’s disease (PD) and “OFF”…OPTI-ON: A Longitudinal Real-World Study of Opicapone in Patients with Parkinson’s Disease and Motor Fluctuations
Objective: To conduct a longitudinal real-world study that examines treatment patterns, clinical outcomes, safety and tolerability of opicapone as an adjunctive treatment to carbidopa/levodopa (CD/LD)…
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