Trial record 3 of 23 for:    neurology AND University AND San Francisco | Open Studies | Exclude Unknown

Efficacy of Isradipine in Early Parkinson Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Rochester
Sponsor:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Kevin Biglan, University of Rochester
ClinicalTrials.gov Identifier:
NCT02168842
First received: June 18, 2014
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Parkinson Disease
Drug: Isradipine
Drug: Placebo (for Isradipine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Unified Parkinson Disease Rating Scale (UPDRS) [ Time Frame: Baseline to 36 months of treatment ] [ Designated as safety issue: No ]
    Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the total (Part I-III) UPDRS score in the active treatment arm versus placebo between the baseline and 36 month visit.


Secondary Outcome Measures:
  • Motor function [ Time Frame: Baseline to 36 months of treatment ] [ Designated as safety issue: No ]
    To explore long term efficacy of isradipine treatment to slow progression of disability as measured by motor function (characterized by UPDRS Part III in the medications OFF state, UPDRS ambulatory capacity subscore, time to initiation of symptomatic therapy, time to onset of motor complications, dosage and utilization of symptomatic therapy, MDS-UPDRS Motor score)

  • Cognitive function [ Time Frame: Baseline to 36 months of treatment ] [ Designated as safety issue: No ]
    To explore long term efficacy of isradipine treatment to slow progression of disability as measured by cognitive function as measured by the Montreal Cognitive assessment Scale (MoCA)

  • Global measures [ Time Frame: Baseline to 36 months of treatment ] [ Designated as safety issue: No ]
    To explore long term efficacy of isradipine treatment to slow progression of disability as measured by Global measures of disability as measured by modified Rankin score

  • Functional status and quality of life [ Time Frame: Baseline to 36 months of treatment ] [ Designated as safety issue: No ]
    To explore long-term efficacy of isradipine to slow progression of disability as measured by functional status and quality of life (Non-Motor Experience of Daily Living)

  • Functional status and quality of life [ Time Frame: Baseline to 36 months of treatment ] [ Designated as safety issue: No ]
    To explore long-term efficacy of isradipine to slow progression of disability as measured by quality of life (PDQ-39)

  • Functional Status and Quality of Life [ Time Frame: Baseline to 36 months of treatment ] [ Designated as safety issue: No ]
    To explore long-term efficacy of isradipine to slow progression of disability as measured by functional status and quality of life (MDS- UPDRS Motor)


Estimated Enrollment: 336
Study Start Date: September 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Isradipine
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Drug: Isradipine
Oral capsules Isradipine IR, up to 10 mg, taken twice daily
Placebo Comparator: Placebo (for Isradipine)
Oral capsule taken twice daily for 36 months.
Drug: Placebo (for Isradipine)
Sugar Pill manufactured to look like Isradipine but has no active ingredients

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02168842

Contacts
Contact: STEADY-PD III Coordinator 855-825-3390 steadypd3@urmc.rochester.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Jeff Worrell    205-996-4034    jworrell@uab.edu   
Principal Investigator: Natividad Stover, MD         
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92093
Contact: Robin Ellam    858-822-5751    rellam@ucsd.edu   
Principal Investigator: Irene Litvan, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Ariane Marcus    415-502-1672    ariane.marcus@ucsf.edu   
Principal Investigator: Chadwick Christine, MD         
United States, Connecticut
Institute of Neurodegenerative Disorders Recruiting
New Haven, Connecticut, United States, 06510
Contact: Meghan Pajonas    203-508-1506    info@indd.org   
Principal Investigator: David Russell, MD PHD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Becky McMurray    404-728-6427    rmcmurr@emory.edu   
Principal Investigator: Marian Evatt, MD         
United States, Hawaii
Pacific Health Research & Education Institute Recruiting
Honolulu, Hawaii, United States, 96819
Contact: Stephanie Terashita    808-636-0681    stephanie.terashita@va.gov   
Principal Investigator: G. Webster Ross, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Samantha Gibson    410-328-4349    sagibson@som.umaryland.edu   
Principal Investigator: Melissa Armstrong, MD         
United States, Massachusetts
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Cathi-Ann Thomas    617-638-7737    neurocat@bu.edu   
Principal Investigator: Marie H Saint-Hilaire, MD         
United States, Michigan
Michigan State University Recruiting
East Lansing, Michigan, United States, 48824
Contact: Doozie Russell    517-884-2274    doozie.russell@hc.msu.edu   
Principal Investigator: John Goudreau, DO         
United States, Nebraska
Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Carolyn Peterson    402-552-2239    cpeterson@nebraska.com   
Principal Investigator: John M Bertoni, MD PHD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Alissa Davis    801-587-8581    alissa.davis@hsc.utah.edu   
Principal Investigator: David Shprecher, DO         
United States, Virginia
Sentara Neurology Specialists Recruiting
Virginia Beach, Virginia, United States, 23456
Contact: Lisa Richardson    757-507-0642    lhrichar@sentara.com   
Principal Investigator: Karen Thomas, DO         
Sponsors and Collaborators
University of Rochester
Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Tanya Simuni, MD Northwestern University
Principal Investigator: Kevin M. Biglan, MD MPH University of Rochester
  More Information

Additional Information:
No publications provided

Responsible Party: Kevin Biglan, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT02168842     History of Changes
Other Study ID Numbers: STEADY-PD III, U01NS080818-01A1, U01NS080840-01A1
Study First Received: June 18, 2014
Last Updated: October 22, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by University of Rochester:
Parkinson
Parkinson Disease

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Isradipine
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014