BELOW IS A LISTING OF STUDIES FOR WHICH THE PARKINSON’S DISEASE AND MOVEMENT DISORDER CENTER IS CURRENTLY ENROLLING PARTICIPANTS. A BRIEF DESCRIPTION AND MAIN INCLUSION/EXCLUSION CRITERIA ARE LISTED. IF YOU ARE INTERESTED IN OBTAINING MORE INFORMATION OR POSSIBLY PARTICIPATING IN ONE OF THE STUDIES PLEASE CONTACT:
KELLY LYONS, PHD
KLYONS@KUMC.EDU OR 913-588-7159
Click the following links for more information
Studies for patients not taking any medication for Parkinson's disease
Studies for Parkinson's disease patients with off-time
Studies for Parkinson's disease patients with hallucinations
Studies for Parkinson's disease patients with dyskinesia
STUDIES FOR PARKINSON'S DISEASE PATIENTS NOT RECEIVING ANY TREATMENT
A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664AM2)
PURPOSE: This is a one year, 2-part study to determine the efficacy and safety of preladenant.
DURATION: 52 weeks
STUDY DESIGN: randomized, double-blind, placebo controlled.
INCLUSION CRITERIA:
30-85 years old
Subjects with a diagnosis of idiopathic PD for < 5 years
Each subject who is receiving amantadine and/or anticholinergics must have been on a stable regimen of treatment for at least the 4 weeks (Note: Subjects who are not taking any medications for PD are permitted to enroll in this trial.)
EXCLUSION CRITERIA:
A subject must not have a form of drug induced or atypical parkinsonism, cognitive impairment, bipolar disorder, schizophrenia, or other psychotic disorder
A subject must not have a history of repeated strokes or head injuries, or a stroke within 6 months
A subject must not have had any clinically significant cardiovascular event or procedure for 6 months, including, but not limited to, myocardial infarction, angioplasty, unstable angina, or heart failure
A subject must not have a history of Hepatitis B or C; Epstein Barr virus (EBV); cytomegalovirus (CMV) or a history of diagnosis of drug or alcohol induced hepatic toxicity
A subject must not have a history within the past 5 years
A subject must not have an average daily consumption of more than three 4 ounce glasses (180 mL) of wine or the equivalent.
Pioglitazone in Early Parkinson's Disease
PURPOSE: This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of oral pioglitazone (15 mg and 45 mg) for safety, tolerability, and futility.
DURATION: 44 Weeks
STUDY DESIGN: double-blind, randomized, placebo-controlled
INCLUSION CRITERIA:
30 years and older
Men and women with idiopathic Parkinson's Disease of less than 5 years duration from diagnosis On stable dosage of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8 weeks but not more than 8 months prior to baseline.
The clinical signs must be asymmetric.
Subjects may be taking stable doses (30 days) of anticholinergics, creatine (< 5gm/day) or Coenzyme Q10 (< 600 mg/day) but must be expected to remain on the same dose.
EXCLUSION CRITERIA:
Presence of freezing.
History of congestive heart failure.
Type I or Type II diabetes mellitus.
Known history of osteoporosis.
Drug or alcohol use or dependence that would interfere with the safe conduct of the study. Current or planned use of gemfibrozil or rifampin during the trial.
History of bladder cancer.
History of macular edema.
Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)
PURPOSE: A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease.
DURATION: 28 weeks
STUDY DESIGN: Randomized, double-blind, placebo-controlled
INCLUSION CRITERIA:
35-75 years old
Confirmed diagnosis of early-stage idiopathic PD within the 2 years prior to screening
Subjects who are not currently receiving any PD treatment
EXCLUSION CRITERIA:
Female of child-bearing potential
History of neurosurgical procedures for PD
History of severe psychiatric illness
STUDIES FOR PARKINSON’S DISEASE PATIENTS WITH OFF-TIME
A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease
PURPOSE: This trial will test the hypothesis that A2a receptor antagonism can lead to improvement in the function of PD subjects, as measured by a reduction in "off" time
DURATION: 12 weeks
STUDY DESIGN: Double-blind, randomized, placebo-controlled
INCLUSION CRITERIA
Each subject must have a diagnosis of moderate to severe idiopathic Parkinson's disease.
Each subject must have received prior therapy with L dopa for approximately 2 or more years. Each subject must have been on a stable dopaminergic treatment regimen for at least the 4 weeks. Each subject must be experiencing motor fluctuations (minimum of 2 hours/day of "off" time). Each subject must be to 85 years of age.
EXCLUSION CRITERIA:
A subject must not have a history of repeated strokes or head injuries, poorly controlled diabetes; abnormal renal function; or a severe or ongoing unstable medical condition.
A subject must not have had surgery for their PD.
A subject must not have a systolic blood pressure (BP) ≥ 140 mm Hg OR diastolic BP ≥ 90 mm Hg at screening.
A subject must not have had any clinically significant cardiovascular event or procedure for 6 months prior to study start .
A subject must not have a history within the past 5 years of malignant disease.
A subject must not have an average daily consumption of more than three 4 ounce glasses of wine or the equivalent.
Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off
PURPOSE: The purpose of this research study is to test the effect of SYN115 compared to placebo on movement during the "on" and "off" states.
STUDY DESIGN: Double-blind, Randomized, Placebo-controlled
INCLUSION CRITERIA:
30-80 years old
Stable regimen of anti-parkinson medications
Are able to complete a Parkinson's disease diary
EXCLUSION CRITERIA:
Secondary or atypical Parkinson's
Treatment with anti-psychotic or memory improving drugs
Subjects with untreated or uncontrolled current episode of major depression
Receipt of any anti-psychotic drugs greater than 1 month in the past 5 years or any exposure in past year
History of hepatitis, cholangitis or Gilbert's disease
Untreated or uncontrolled hypothyroidism or hyperthyroidism
Drops in blood pressure requiring medication to maintain blood pressure
Finding of malignant melanoma on full body skin exam
Impulse disorder conditions
STUDIES FOR PARKINSON’S DISEASE PATIENTS WITH HALLUCINATIONS OR PSYCHOSIS
A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis
PURPOSE: To evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP).
DURATION: 6 weeks
STUDY DESIGN: double-blind, randomized, placebo-controlled
INCLUSION CRITERIA:
40 years and older
A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
Subject must be on stable dose of anti-Parkinson’s disease medication for 1 month prior to study day 1 and during the trial
Caregiver is willing and able to accompany the subject to all visits
Exclusion criteria:
Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
Subject has had a myocardial infarction in last six months
Subject has any surgery planned during the screening, treatment or follow-up periods
The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP).
STUDIES FOR PARKINSON'S DISEASE PATIENTS WITH DYSKINESIA
Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
PURPOSE: To evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine
DURATION: 8 weeks
STUDY DESIGN: multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study
INCLUSION CRITERIA:
30- 80 years old
Parkinson's disease
On a stable regimen of antiparkinson's medications
Experiencing troublesome dyskinesia following levodopa dosing (peak dose dyskinesia)
EXCLUSION CRITERIA:
History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation)
History of seizures or stroke/TIA within 2 years of screening
History of cancer within 5 years of screening, except adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer
Presence of cognitive impairment
If you are interested in participating in clinical trials, please fill out the following information.
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