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Parkinson's Disease Research Studies

Study Title:  A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease (TEVA TVP1012) Phase 4 (Identifier: NCT01723228)

Study Purpose:  This is a 24-week, multicenter, randomized, double-blind, placebo-controlled, add-on, parallel-group study to evaluate the effect of rasagiline on cognitive function in adults with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI).

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  (Identifier: NCT01927055).

Study Purpose:  Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients wtih symptomatic NOH.

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:  A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose, Parallel Group Study to Evaluate the Pharmacodynamics, Efficacy and Safety of RM-131 Administered to Patients With Parkinson's Disease and Chronic Constipation Dissatisfied With Current Therapy (Identifier NCT01955616).

Study Purpose:  The purpose of this study, called MOVE-PD, is to investigate how individuals with Parkinson's disease (PD) and chronic constipation (CC) respond to RM-131 as compared to placebo. The study will look at how well RM-131 affects the frequency of spontaneous bowel movements over a 14-day period. The study will also evaluate the safety and tolerability of the study drug and evaluate whether the study drug relieves the uncomfortable GI symptoms related to chronic constipation in patients who are unsatisfied with other therapies they have tried for constipation.

Principal Investigator: Lawrence Elmer, MD

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


Study Title:  A Phase 2B, Twelve-week Mulit-Center, Randomized Double-Blind, Placebo Controllwed, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects with Early Parkinson’s Disease (PD) (Identifier NCT01968460)

Study Purpose: This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and rasagiline for the treatment of early Parkinson's disease.

Principal Investigator:  Lawrence Elmer, MD

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


Study Title:   Efficacy and Safety of ADS – 5102 (Amantadine HCL) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkenson’s Disease Patients (Identifier NCT02136914)

Study Purpose:  This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep.

Principal Investigator: Lawrence Elmer, MD

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

 

 

Last Updated: 7/2/14