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Parkinson's Disease Research Studies

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:   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: 8/27/15