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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)  (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:  A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease (Identifier: NCT01968031).

Study Purpose:  A double-blinded, randomized, placebo-controlled study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease who are already on Levodopa/Carbidopa or Levodopa/Benserazide therapy. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group. Patients will continue on their existing Levodopa combination therapy throughout the study period.

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" (Identifier NCT02453386)

Principal Investigator: Lawrence Elmer, MD

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


 

Last Updated: 4/22/16