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Parkinson's Disease Research Studies

Study Title:   An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes, Cynapsus)  (Identifier NCT02542696)

Study Purpose:  A 24-week, prospective, multi-center, open-label, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to evaluate the long-term safety, tolerability and efficacy of APL-130277.

Principal Investigator: Lawrence Elmer, MD

Study Coordinator:  Stephanie Wilson, RN, for more information, please call 419.383.6721


Study Title:   Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID).   (Identifier NCT02202551)

Study Purpose:  This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).

Principal Investigator: Lawrence Elmer, MD

Study Coordinator:  Stephanie Wilson, RN, for more information, please call 419.383.6721


Study Title:   A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson's Disease Experiencing End of Dose "Wearing-off" (Biotie TOZ-CL05) (Identifier NCT02453386)

Principal Investigator: Lawrence Elmer, MD

Study Coordinator:  Stephanie Wilson, RN, for more information, please call 419.383.6721


Study Title:  A Clinical Study of Patients with Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy (RESTORE).  (Identifier NCT02586623)

Study Purpose:  The purpose of this study is to evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) deficiency who have been previously stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH) (dizziness, light-headedness, or feelings that they are about to black out).

Principal Investigator: Lawrence Elmer, MD

Study Coordinator:  Stephanie Wilson, RN, for more information, please call 419.383.6721


Study Title:   A 15-Week, Phase II, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging Study to Investigate the Efficacy, Safety and Tolerability of PF-06649751 in Subjects with Motor Fluctuations Due to Idiopathic Parkinson’s Disease. (Identifier NCT02687542)

Study Purpose:  The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.

Principal Investigator: Lawrence Elmer, MD

Study Coordinator:  Stephanie Wilson, RN, for more information, please call 419.383.6721


Study Title:   A Phase 3, Long-Term, Open-label Study of Istradefylline in Subjects with Moderate to Severe Parkinson's Disease. (Identifier NCT02610231)

Study Purpose:  This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination (levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for eligibility for the study. Eligible subjects will be treated with istradefylline at a starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on the Investigator's judgment of each subject's response and tolerability. If deemed necessary, one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in accordance with clinical judgment of the Investigator. Subjects who had a dose adjustment to 40 mg/d can have their dose decreased to 20 mg/d by the Investigator at a second unscheduled dose adjustment visit if there are tolerability issues. The istradefylline dose should remain fixed between Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is required prior to any unscheduled dose adjustment visits. A subject may discontinue from the study at any time.

Principal Investigator: Lawrence Elmer, MD

Study Coordinator:  Stephanie Wilson, RN, for more information, please call 419.383.6721


 

Last Updated: 9/22/16