Available Clinical Trials

Clinical trials are studies designed to find new and better ways to treat patients with Parkinson's disease and other movement disorders. The physicians at the Maryland Parkinson's Disease and Movement Disorders Center are currently conducting the clinical trials listed below.

Studies open frequently. If interested in the latest information regarding our studies, please call Michelle Cines, BSN, CCRC at 410-328-7809 (Press 1).

Clinical Trial Detail - Efficacy of Isradipine as a disease modifying agent in early Parkinson disease

Definition:

The Parkinson Study Group is conducting a multi-center, randomized, double-blind, placebo-controlled study of isradipine in patients with early Parkinson disease (PD) called STEADY-PD III. This study plans to enroll newly diagnosed PD patients not yet in need of symptomatic therapy.  Isradipine is already approved for the treatment of high blood pressure and has been shown to slow the progression of PD by protecting dopaminergic neurons in animal models. To learn more about STEADY-PD III, please visit http://www.STEADYPD3.com, http://www.clinicaltrials.gov or call 1-855-825-3390.  

Investigator:

Dr. Melissa Armstrong

Eligibility:

Inclusion Criteria:

  • Subjects with early idiopathic PD (presence of two out of three cardinal manifestations of PD). If tremor is not present, subjects must have unilateral onset and persistent asymmetry of the symptoms
  • Age equal or greater than 30 years at the time of diagnosis of PD
  • Hoehn and Yahr stage less than or equal to 2
  • Diagnosis of PD less than 3 years.
  • Currently NOT receiving dopaminergic (levodopa, dopamine agonist or MAO-B inhibitors) therapy and NOT projected to require PD symptomatic therapy for at least 3 months from the baseline visit
  • Use of amantadine and/or anticholinergics will be allowed provided that the dose is stable for 12 weeks prior to the baseline visit
  • If subject is taking any central nervous system acting medications (e.g. benzodiazepines, antidepressants, hypnotics) regimen must be stable for 30 days prior to the baseline visit
  • Women of childbearing potential may enroll but must use a reliable measure of contraception and have a negative serum pregnancy test at the screening visit

Exclusion Criteria:

  • Subjects with a diagnosis of an atypical Parkinsonism
  • Subjects unwilling or unable to give informed consent
  • Exposure to dopaminergic PD therapy within 60 days prior to baseline visit or for consecutive 3 months or more at any point in the past
  • History of clinically significant orthostatic hypotension or presence of orthostatic hypotension at the screening or baseline visit defined as greater than or equal to 20 mmHg change in systolic BP and greater than or equal to 10 mmHg change in diastolic BP from sitting position to standing after 2 minutes, or baseline sitting BP less than 90/60
  • History of congestive heart failure
  • Clinically significant bradycardia
  • Presence of 2nd or 3rd degree atrioventricular block or other significant ECG abnormalities that in the investigator's opinion would compromise participation in study
  • Clinically significant abnormalities in the Screening Visit laboratory studies or electrocardiogram
  • Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study
  • Prior exposure to isradipine or other dihydropyridine calcium channel blockers within 6 months of the baseline visit
  • Subjects on greater than 2 concomitant antihypertensive medications. If a history of hypertension, then a maximum of 2 other antihypertensive agents will be allowed provided that the dosages of concomitant anti HTN therapy can be reduced/adjusted during the study based on the BP readings in consultation with the subject's primary care physician or cardiologist. Use of any concomitant calcium channel blockers will not be allowed from the baseline visit and for the duration of the study
  • Use of grapefruit juice, ginkgo biloba, St. John's wort or ginseng will be prohibited starting from the screening visit and for the duration of the study (as they interfere with the metabolism of isradipine)
  • Use of clarithromycin and erythromycin will be prohibited starting from the screening visit and for the duration of the study as the combination of clarithromycin or erythromycin and calcium channel blockers has been reported to be associated with increased risk of kidney injury
  • Presence of cognitive dysfunction defined by a Montreal Cognitive assessment (MoCA) score of less than 26 at screening
  • Subjects with clinically significant depression as determined by a Beck Depression Inventory II (BDI) score greater than 15 at the screening visit
  • History of exposure to typical or atypical antipsychotics or other dopamine blocking agents within 6 months prior to the baseline visit
  • History of use of an investigational drug within 30 days prior to the screening visit
  • History of brain surgery for PD
  • Allergy/sensitivity to isradipine or its matching placebo or their formulations
  • Pregnant or lactating woman

Contact:

If you would like information from your local study team, please contact Samantha Gibson, Study Coordinator at sagibson@som.umaryland.edu or (410) 328-4349.

Clinical Trial Detail - Exercise Study: Click here for more information.

Definition:

The Veteran's Affairs Medical Center has funded this study investigate ways to improve memory in Parkinson's disease. Executive memory loss is common in Parkinson's Disease (PD). There is no known treatment for it. This study looks at whether executive memory function is improved in PD by either treadmill aerobic training, computerized memory training, or a combination of both.

Investigator:

Frederick Ivey, Ph.D.

Eligibility:

Participants must have been diagnosed with Parkinson's Disease.

Contact:

For more information or to inquire about participating, call Terra Hill at 443-827-0677.

This page was last updated: October 15, 2014

         
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