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Official Study Title: A Pilot Phase II Double-Blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. Placebo-Controlled, Tolerability and Dosage Finding Study of Isradipine CR as a Disease Modifying Agent in Patients with Early Parkinson Disease
Sponsor: Parkinson Study Group
Clinicaltrials.gov ID: NCT00909545
Study ID:

Summary

The Parkinson Study Group (PSG) is conducting a study of the research medication isradipine CR in persons who have a recent diagnosis of Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD). Isradipine CR is a medication that is approved for the treatment of high blood pressure by the Food and Drug Administration  Food and Drug AdministrationThe U.S. Department of Health and Human Services is the agency responsible for ensuring the safety and effectiveness  EffectivenessAbility of a drug or treatment to produce a result. of all drugs, biologics, vaccines, and medical devices. Internet address: http://www.fda.gov. Agency (FDA), but not for the treatment of PD. STEADY-PD is designed to determine general safety, tolerability and to obtain pilot data on potentially effective doses of isradipine CR for slowing the progression of PD.

This study is partially funded by the Michael J. Fox Foundation for Parkinson’s Research and Northwestern University Dixon Foundation.

 

Study Phase

Phase 2
What is a study phase?

Symptoms Addressed: Movement and Non-movement

General PD symptoms

Time Commitment

• More than six months
• 11 in-person visits and 3 phone calls

Eligibility

• Gender(s) Accepted: Either
• Maximum Years Since Diagnosis: 3

Inclusion Criteria

You may be eligible for this study if you:

• Have a diagnosis of PD of less than 3 years
• Were over 30 years old at the time of diagnosis
• Are able to provide written informed consent
• Are able to take oral medication and be willing to comply with study-specific procedures
• May not be taking dopaminergic therapy  TherapyAnother word for “treatment”. (carbidopa/  CarbidopaDrug given in combination with levodopa to ensure that more of the latter reaches the brain and changes into dopamine, rather than being broken down in the bloodstream. This allows for lower doses of levodopa to be used, reducing the risk of nausea, vomiting, and other side effects. levodopa  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. or dopamine  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. agonists) and not projected to require therapy for 6 months after enrollment
• May be taking MAO Inhibitors (rasagiline and selegiline)  SelegilineInhibitor that increases the amount of dopamine in the brain to help control the symptoms of Parkinson's in people who are taking levodopa and carbidopa in combination (Sinemet). Selegiline may help people with Parkinson's to decrease the dose of levodopa/carbidopa needed to control symptoms, stopping the effects of levodopa/carbidopa from wearing off between doses, and increasing the length of time that levodopa/carbidopa will continue to control symptoms. , amantadine and anticholinergic medcations if stable for 3 months
  

Exclusion Criteria

You may not be eligible for this study if you: 

• Have a diagnosis of an atypical Parkinsonism
• Have significant low blood pressure
• Have heart failure
• Have a heart rate of less than 55
• Have significant EKG abnormality
• Show significant abnormalities in the Screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. Visit in blood, urine or an electrocardiogram
• Have other significant medical or psychiatric problem(s) that in the investigator’s opinion would compromise participation in the study
• Have been exposed to several other medications (the study staff will review these with you)
• Have significant cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. impairment or depression
• Have participated in other investigational drug  Investigational DrugDrug that is being tested in clinical trials prior to receiving FDA approval for use on the open market or as a treatment for a particular condition. trials within 30 days
• Have undergone brain surgery for PD
  
• Use of grapefruit juice, Ginkgo biloba, St. John’s wart and ginseng will be prohibited during the study (as they interfere with the study drug)
• Women of childbearing potential who are not surgically sterilized must agree to use a reliable birth control measure

Enrollment

Expected Enrollment: 100 (US)
Date Enrollment Began: Jul 2009
Date Enrollment Ends: Oct 2010
Last Updated Date: Aug 19 2010
Trial Post Date: Jul 20 2009
Website: http://www.parkinson-study-group.org/

Primary Contacts and Locations

New York

• IRENITA GARDNER, RN, CCRC
  nita.gardiner@ctcc.rochester.edu
  Phone: (585) 275-7311
  1351 MT. HOPE AVENUE
  ROCHESTER, NY 14620
  USA
  
• CHERYL DEELEY, MS, RNc
  Cheryl.deeley@ctcc.rochester.edu
  Phone: (585) 341-7515
  1351 MT. HOPE AVENUE
  ROCHESTER, NY 14620
  USA
  

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