Efficacy of Isradipine in Early Parkinson Disease

Condition(s) targeted: Parkinson Disease

Intervention: Isradipine (Drug); Placebo (for Isradipine) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Rochester

Official(s) and/or principal investigator(s):
Tanya Simuni, MD, Principal Investigator, Affiliation: Northwestern University
Kevin M. Biglan, MD MPH, Principal Investigator, Affiliation: University of Rochester

Overall contact:
STEADY-PD III Coordinator, Phone: 855-825-3390, Email: steadypd3@urmc.rochester.edu

The purpose of the study is to determine whether treatment with isradipine is effective in slowing the progression of Parkinson disease disability.

Official title: Phase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Unified Parkinson Disease Rating Scale (UPDRS)

Secondary outcome:

Motor function

Cognitive function

Global measures

Functional status and quality of life

Functional status and quality of life

Functional Status and Quality of Life

Detailed description: The study will enroll 336 participants in this multi-center study at approximately 56 sites across the US and Canada. In this study, we are comparing 10 mg of Isradipine to Placebo for treatment of newly diagnosed PD patients. Isradipine has been approved by the Food and Drug Administration (FDA) to treat high blood pressure but is considered investigational in this study, as it has not been approved for use in patients with PD. Isradipine can affect the function of specialized channels that are present in the types of brain cells that are affected in PD patient. These cells are usually responsible for making dopamine, which is depleted in patients with PD. Isradipine may block the damage caused by the flow of certain chemicals through these channels. Laboratory data has showed that Isradipine may prevent the development of Parkinson-like symptoms in animal studies. Isradipine has been evaluated in some patients with PD. The first study with isradipine controlled release (CR) in patients with early PD and normal blood pressure found that the drug was reasonably well tolerated and safe. The controlled release formulation of isradipine is not available for use and therefore this study is using the immediate release formulation. Eligible participants will be followed for up to 36 months and will be expected to complete 12 in-person visits and 4 telephone visits. The study visits will include clinical assessment of motor, neuropsychiatric and cognitive testing as well as collection of blood and urine samples. Study drug will taken twice daily, in the morning and in the evening with or without food. Prior to taking study drug, study participants will be required to take their blood pressure with a home blood pressure device provided to them for use in this study.

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects with early idiopathic PD (presence of at least 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 therapy (levodopa, dopamine agonist or MAO-B

inhibitors) 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 8 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 ECG

- 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 provider 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, telithromycin and erythromycin will be prohibited starting

from the screening visit and for the duration of the study as the combination of clarithromycin, telithromycin or erythromycin and calcium channel blockers has been reported to be associated with increased risk of kidney and heart 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

STEADY-PD III Coordinator, Phone: 855-825-3390, Email: steadypd3@urmc.rochester.edu

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States; Recruiting
Jeff Worrell, Phone: 205-996-4034, Email: jworrell@uab.edu
Natividad Stover, MD, Principal Investigator

University of Calgary, Calgary, Alberta T2N 4Z6, Canada; Recruiting
Lorelei Tainish, Phone: 403-220-8413, Email: derwent@ucalgary.ca
Ranjit Ranawaya, MD, Principal Investigator

University of Alberta Hospital, Edmonton, Alberta t6g 2g3, Canada; Recruiting
Paul McCann, Phone: 780-407-1614, Email: paul.mccann@albertahealthservices.ca
Oksana Suchowersky, MD, Principal Investigator

Banner Sun Health Research Institute, Sun City, Arizona 85315, United States; Recruiting
Molly Goddard, Phone: 623-832-5726, Email: molly.goddard@bannerhealth.com
Holly Shill, MD, Principal Investigator

The Parkinsons & Movement Disorder Institute, Fountain Valley, California 92708, United States; Recruiting
Rosie Magallon, Phone: 714-378-5021, Email: rmagallon@pmdi.org
Daniel D Truong, MD, Principal Investigator

University of California, Irvine, California 92697, United States; Recruiting
Katrina Samson, Phone: 949-824-3485, Email: samsonk@uci.edu
Neal Hermanowicz, MD, Principal Investigator

University of California, San Diego, San Diego, California 92093, United States; Recruiting
Robin Ellam, Phone: 858-822-5751, Email: rellam@ucsd.edu
Irene Litvan, MD, Principal Investigator

University of California, San Francisco, San Francisco, California 94143, United States; Recruiting
Ariane Marcus, Phone: 415-502-1672, Email: ariane.marcus@ucsf.edu
Chadwick Christine, MD, Principal Investigator

Rocky Mountain Movement Disorders Center, Englewood, Colorado 80113, United States; Recruiting
Breanna Nickels, Phone: 303-357-5445, Email: nickels@kumarneuro.com
Rajeev Kumar, MD, Principal Investigator

Eastern Connecticut Neurology Specialists, Manchester, Connecticut 06040, United States; Recruiting
Sheila Thurlow, Phone: 860-647-7831, Email: thurlow@uchc.edu
Antonelle J DeMarcaida, MD, Principal Investigator

Institute of Neurodegenerative Disorders, New Haven, Connecticut 06510, United States; Recruiting
Meghan Pajonas, Phone: 203-508-1506, Email: info@indd.org
David Russell, MD PHD, Principal Investigator

University of Miami, Miami, Florida 33136, United States; Recruiting
Nathalie Padron, Phone: 305-243-3530, Email: npadron@med.miami.edu
Corneliu Luca, MD, Principal Investigator

University of South Florida, Tampa, Florida 33613, United States; Recruiting
Claudia Rocha, Phone: 813-396-0757, Email: Crocha1@health.usf.edu
Deborah Burke, MD, Principal Investigator

Cleveland Clinic Florida-Weston, Weston, Florida 33331, United States; Recruiting
Pamela Lackner, Phone: 954-659-6843, Email: lacknep@ccf.org
Nestor Galvez-Jimenez, MD, Principal Investigator

Emory University, Atlanta, Georgia 30329, United States; Recruiting
Becky McMurray, Phone: 404-728-6427, Email: rmcmurr@emory.edu
Marian Evatt, MD, Principal Investigator

Pacific Health Research & Education Institute, Honolulu, Hawaii 96819, United States; Recruiting
Stephanie Terashita, Phone: 808-636-0681, Email: stephanie.terashita@va.gov
G. Webster Ross, MD, Principal Investigator

Northwestern University, Chicago, Illinois 60611, United States; Recruiting
Karen Williams, Phone: 312-503-5645, Email: k-williams8@northwestern.edu
Cindy Zadikoff, MD FRCPC, Principal Investigator

Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting
Lucia Blasucci, Phone: 312-563-2184, Email: Lucia_m_blasucci@rush.edu
Katie Kompoliti, MD, Principal Investigator

University of Kentucky Medical Center, Lexington, Kentucky 40536, United States; Recruiting
Renee Wagner, Phone: 859-323-0028, Email: renee.wagner@uky.edu
John T Slevin, MD, Principal Investigator

LSU Health Science Center, Shreveport, Louisiana 71103, United States; Recruiting
Richard Zweig, Phone: 318-675-5683, Email: rzweig@lsuhsc.edu
RIchard Zweig, MD, Principal Investigator

Johns Hopkins University, Baltimore, Maryland 21287, United States; Recruiting
Becky Dunlop, Phone: 410-955-8795, Email: rdunlop@jhmi.edu
Kelly Mills, MD, Principal Investigator

University of Maryland, Baltimore, Maryland 21201, United States; Recruiting
Samantha Gibson, Phone: 410-328-4349, Email: sagibson@som.umaryland.edu
Melissa Armstrong, MD, Principal Investigator

Boston University Medical Center, Boston, Massachusetts 02118, United States; Recruiting
Cathi-Ann Thomas, Phone: 617-638-7737, Email: neurocat@bu.edu
Marie H Saint-Hilaire, MD, Principal Investigator

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Grace Bwala, Phone: 617-643-0654, Email: gbwala@partners.org
Albert Hung, MD PHD, Principal Investigator

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Grace Bwala, Phone: 617-643-0654
Albert Hung, MD PHD, Principal Investigator

University of Michigan, Ann Arbor, Michigan 48109, United States; Recruiting
Jamie Miller, Phone: 734-936-4817, Email: jamieann@med.umich.edu
Kelvin Chou, MD, Principal Investigator

Michigan State University, East Lansing, Michigan 48824, United States; Recruiting
Doozie Russell, Phone: 517-884-2274, Email: doozie.russell@hc.msu.edu
John Goudreau, DO, Principal Investigator

Struthers Parkinson's Center, Golden Valley, Minnesota 55427, United States; Recruiting
Kathryn Duderstadt, Phone: 952-993-5903, Email: kathryn.duderstadt@parknicollet.com
Sotirios Parashos, MD PHD, Principal Investigator

University of Minnesota, Minneapolis, Minnesota 55414, United States; Recruiting
Susan Rolandelli, Phone: 612-624-7745, Email: cnru@umn.edu
Paul Tuite, MD, Principal Investigator

Washington University, St. Louis, Missouri 63110, United States; Recruiting
Laura Rundell, Phone: 314-362-3372, Email: rundelll@neuro.wustl.edu
Brad A. Racette, MD, Principal Investigator

Nebraska Medical Center, Omaha, Nebraska 68198, United States; Recruiting
Carolyn Peterson, Phone: 402-552-2239, Email: carolyn.peterson@unmc.edu
John M Bertoni, MD PHD, Principal Investigator

University of Nevada School of Medicine, Las Vegas, Nevada 89102, United States; Recruiting
Shamine Poynor, Phone: 702-671-5093, Email: spoynor@medicine.nevada.edu
Eric Farbman, MD, Principal Investigator

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Recruiting
Polly Leblanc, Phone: 603-650-4411, Email: paulilne.r.leblanc@hitchcock.org
Stephen Lee, MD PHD, Principal Investigator

Atlantic Neuroscience Institute, Summit, New Jersey 07901, United States; Recruiting
Diane Babek, Phone: 908-598-7991, Email: diane.babek@atlantichealth.org
Roger Kurlan, MD, Principal Investigator

Health Quest Kingston, Kingston, New York 12401, United States; Recruiting
Cindy Miller, Phone: 845-331-5165, Ext: 1143, Email: cmiller6@health-quest.org
Fabio Danisi, MD, Principal Investigator

North Shore LIJ Health System, Manhasset, New York 11030, United States; Recruiting
Jean Ayan, Phone: 516-562-2426, Email: jayan@nshs.edu
Andrew Feigin, MD, Principal Investigator

Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Amber Servi, Phone: 212-305-3938, Email: ads2178@cumc.columbia.edu
Cheryl Waters, MD, Principal Investigator

Weill Medical College of Cornell University, New York, New York 20021, United States; Recruiting
James Carter, Phone: 212-746-2474, Email: jac3003@med.cornell.edu
Alexander Shtilbans, MD PHD, Principal Investigator

University of Rochester, Rochester, New York 14618, United States; Recruiting
Ashley Owens, Phone: 585-341-7593, Email: ashley_owens@urmc.rochester.edu
Irene Richard, MD, Principal Investigator

University of Cincinnati, Cincinnati, Ohio 45267, United States; Recruiting
Hilary Perez, Phone: 513-558-0112, Email: hilary.perez@uc.edu
Alok Sahay, MD, Principal Investigator

The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States; Recruiting
Yvette Pitchford, Phone: 216-444-7513, Email: ellisy@ccf.org
Anwar Ahmed, MD, Principal Investigator

Ohio State University, Columbus, Ohio 43221, United States; Recruiting
Kate Ambrogi, Phone: 614-688-6685, Email: katherine.ambrogi@osumc.edu
Ariane Park, MD MPH, Principal Investigator

Ottawa Hospital Civic Site, Ottawa, Ontario K1Y 4E9, Canada; Recruiting
Jennifer Conway, Phone: 613-761-4583, Email: jeconway@toh.on.ca
Tiago Mestre, MD, Principal Investigator

Toronto Western Hospital, University Health Network, Toronto, Ontario M5T 2S8, Canada; Recruiting
Julie Racioppa, Phone: 416-603-5800, Ext: 2670, Email: julie.racioppa@uhnresearch.ca
Connie Marras, MD, Principal Investigator

Oregon Health & Science University, Portland, Oregon 97239, United States; Recruiting
Kellie Keith, Phone: 503-494-9531, Email: keithk@ohsu.edu
Matthew Brodsky, MD, Principal Investigator

Milton S Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Trang Doan, Phone: 717-531-0003, Ext: 287693, Email: tdoan@hmc.psu.edu
Thyagarajan Subramanian, MD, Principal Investigator

University of Pennsylvania, Philadelphia, Pennsylvania 19107, United States; Recruiting
Jeana LaBrie, Phone: 215-829-3582, Email: jeana.labrie@uphs.upenn.edu
Andres Deik, MD, Principal Investigator

CHUM - Hopital Notre-Dame, Montreal, Quebec H2L 4M1, Canada; Recruiting
Monica Beland, Phone: 514-890-8000, Ext: 26512, Email: Monica.beland.chum@ssss.gouv.qc.ca
Michel Panisset, MD, Principal Investigator

Centre Hospitalier Affilie, Quebec City, Quebec G1J 1Z4, Canada; Recruiting
Caroline Tremblay, Phone: 418-649-0252, Ext: 1516, Email: tremblay.caroline@crchudequebec.ulaval.ca
Melanie Langlois, MD

Medical University of South Carolina, Charleston, South Carolina 29401, United States; Recruiting
Shonna Jenkins, Phone: 845-792-9115, Email: jenkinsho@musc.edu
Vanessa Hinson, MD PHD, Principal Investigator

University of Texas Health Science Center, Houston, Texas 77030, United States; Recruiting
Vicki Ephron, Phone: 713-704-6861, Email: vicki.j.ephron@uth.tmc.edu
Mya C Schiess, MD, Principal Investigator

University of Utah, Salt Lake City, Utah 84108, United States; Recruiting
Alissa Davis, Phone: 801-587-8581, Email: alissa.davis@hsc.utah.edu
David Shprecher, DO, Principal Investigator

University of Virginia, Charlottesville, Virginia 22903, United States; Recruiting
Allison Mann, Phone: 434-924-0453, Email: adm4g@virginia.edu
Binit Shah, MD, Principal Investigator

Sentara Neurology Specialists, Virginia Beach, Virginia 23456, United States; Recruiting
Lisa Richardson, Phone: 757-507-0642, Email: lhrichar@sentara.com
Karen Thomas, DO, Principal Investigator

Booth Gardner Parkinson's Care Center, Kirkland, Washington 98034, United States; Recruiting
Cherissa Sia, Phone: 425-899-3126, Email: csia@evergreenhealthcare.org
Pinky Agarwal, MD, Principal Investigator

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting
Lynn Wheeler, Phone: 414-805-9307, Email: lwheeler@mcw.edu
Karen Blindauer, MD, Principal Investigator

STEADY-PD III Study Website

Starting date: September 2014
Last updated: June 10, 2015