Clinical Trials in Progress in Parkinson's Disease

Updated June 14, 2010

CLINICAL TRIALS IN PROGRESS

SPIN-PD: Spectroscopy in Parkinson Disease Diagnosis

...Recruitment for SPIN-PD is currently underway...

The Parkinson Study Group (PSG), under the direction of Anthony Lang, MD (Toronto Western University), and Bernard Ravina, MD, MSCE (University of Rochester), is conducting a multi-center observational study in individuals with Parkinson disease (PD). The purpose of the study is to assess the potential for biomarkers in diagnosis of PD and secondly, whether these biomarkers are predictors of disease progression. Approximately 37 research centers across North America will enroll up to 300 PD subjects and 200 Healthy Controls to be followed for 2 years.

Biospectroscopy technologies are able to identify the presence of biomarkers in blood plasma. Previously Molecular Biometrics, Inc. has demonstrated these biomarkers could be used to distinguish PD subjects from normal elderly controls. The goal of this study is to expand on earlier studies to determine if this technique can serve as a quick, non-invasive method of early identification of PD or as a biomarker for PD progression (see reference: Schipper et al. Biomarkers Med. 2008:2(3);229-238).

This study is being conducted with funds provided by Molecular Biometrics, Inc. made possible through grants from the Michael J. Fox Foundation and The National Institute of Neurological Disorders and Stroke. Dr. Hyman Schipper, Medical Director-Neuroscience, is the Company’s principal investigator for this study.

If you are interested in learning more about this study, please contact the Parkinson Study Group toll free at 1-888-887-3774 or see the study on www.ClinicalTrials.gov.

SURE-PD (Safety and Ability to Elevate Urate in Early Parkinson’s
Disease): A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral Inosine to Assess Safety and Ability to Elevate Urate in Early Parkinson's Disease

...Recruitment for SURE-PD is currently underway...

The SURE-PD study is being conducted by the Parkinson Study Group (PSG) under the direction of Principal Investigator Michael Schwarzschild, MD, PhD (Massachusetts General Hospital), Alberto Ascherio, MD, DRPH (Harvard School of Public Health), and Karl Kieburtz, MD, MPH (University of Rochester). The Michael J. Fox Foundation for Parkinson’s Research is funding the study.

Urate, also known as uric acid, is a substance that is a normal part of human blood (serum) and cerebrospinal fluid (CSF). There is some recent evidence that urate levels might predict both the risk of PD and its worsening over time (progression). Higher levels of urate may be related to a slower decline in PD. However, there is a need to conduct a well-designed clinical trial to find out if higher urate and slower PD decline just happen to occur together, or if urate causes PD to slow down.

Inosine, a nutritional supplement, is a substance that might be able to make such a clinical trial possible. When taken by mouth, inosine is absorbed by the body and changed into urate. Therefore, people who take inosine by mouth should be able to raise (elevate) the levels of urate in their bodies. But before we start a large study to see if inosine can change the progression of PD, it is best to find out in a smaller, pilot study some important things about inosine, about patient safety, and about the best research plan to answer our questions.

Therefore, SURE-PD has several purposes. We will look at how safe inosine is in patients with early PD, and if it causes side effects. We will also see if inosine can raise urate levels in serum and in CSF in patients with early PD. This information will help us decide whether and how to proceed with a larger study of inosine’s ability to slow down the rate of worsening disability in PD.

To participate in SURE-PD individuals must have at least two of the cardinal signs of PD (resting tremor, bradykinesia, rigidity), be age 30 or older at the time of PD diagnosis, have been diagnosed with PD within the past 3 years, and currently not be taking or needing any treatment for PD. Ninety participants will be enrolled at 11 sites across the U.S. and randomized to one of three treatment groups: 1) those who will receive placebo, 2) those who will receive inosine dosed to produce a mild elevation in urate levels, and 3) those who will receive inosine dosed to produce a moderate elevation in urate levels. Participants will be seen for two screening visits and then 14 visits over 25 months.

If you are interested in learning more about this study, please contact the Parkinson Study Group toll free at 1-888-887-3774 or see the study on www.pdtrials.org www.ClinicalTrials.gov (NCT00833690) where the participating sites are listed.

STEADY-PD: Safety, Tolerability, and Efficacy Assessment of Dynacirc® CR for Parkinson's Disease

...Recruitment for STEADY-PD is currently underway...

The Parkinson Study Group (PSG), under the direction of Tanya Simuni, MD (Northwestern University), and Kevin Biglan, MD, MPH (University of Rochester), is conducting a multi-center, randomized, double-blind, placebo-controlled study of isradipine CR (Dynacirc® CR) in individuals with early Parkinson disease (PD) The purpose of the study is to assess the general safety and tolerability of isradipine CR, to determine effective dosage of isradipine CR and obtain pilot data on the potential effect of isradipine on slowing the progression of PD. Approximately 18 research centers across North America will enroll up to 100 subjects for 12 months each.

Isradipine CR is a medication that is approved for the treatment of high blood pressure by the Food and Drug Administration Agency (FDA), but not for the treatment of PD. Isradipine CR has been shown to have a neuroprotective effect in preclinical models of parkinsonism (see reference: Simuni T, Martel A, Zadikoff C, Videnovic A, Vainio L, Weaver F, Williams K, Surmeier DJ. Safety and tolerability of isradipine, a dihydropyridine calcium channel blocker, in patients with early Parkinson’s disease. Abstract. Mov Disord 2008;23(11):1629).

This study is being conducted under a research grant award from the Michael J. Fox Foundation (MJFF) and the Dixon Foundation.

If you are interested in learning more about this study, please contact the Parkinson Study Group toll free at 1-888-887-3774 or see the study on www.ClinicalTrials.gov where the participating sites are listed.

Effects of Coenzyme Q10 in Parkinson Disease – Phase 3 (QE3)

...Recruitment for QE3 is in progress...

The Parkinson Study Group (PSG), under the direction of Principal Investigators Neurologist Flint Beal, MD (Weill Medical College of Cornell University) and Biostatistician David Oakes, PhD (University of Rochester) and Co-Principal Investigator Neurologist Ira Shoulson, MD (University of Rochester), is conducting a multi-center, randomized, double-blind, placebo-controlled study of Coenzyme Q10 (CoQ) in individuals with Parkinson disease. The objective of this study, called ‘QE3’, is to evaluate the safety and effectiveness of high dosages of CoQ in slowing clinical decline in patients who have early Parkinson disease. Current medications are able to treat many of the symptoms of Parkinson disease, but there is no treatment to slow disease progression.

CoQ is a naturally occurring substance in the body and is also a nutritional supplement. The CoQ in this study, which will also contain vitamin E, is being studied as an investigational drug at higher dosages and, in previous studies, has been well tolerated with no serious safety issues reported.
Participants 30 years of age or older, diagnosed with Parkinson disease within the last 5 years, and are not yet receiving symptomatic treatment may be eligible for the study. Study doctors will follow participants every four months over a 16 month period. Researchers at approximately 60 clinical sites in the United States and Canada will enroll a total of 600 research subjects with early signs of Parkinson disease. Each center will enroll approximately 10 participants. Enrollment began in January 2009.

This study is sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH). If you are interested in learning more about this study, please contact the Parkinson Study Group toll free at 1-888-887-3774. This trial is also listed on ClinicalTrials.gov. For a list of participating centers, see the QE3 Participating Site List.

PROGENI: Parkinson's Research: The Organized GENetics Initiative

...Recruitment for PROGENI is in progress...To obtain additional information call 1-888-830-6299. Outside the United States, call 1-317-274-5734.

PROGENI (Parkinson's Research: The Organized GENetics Initiative) is a NIH-funded collaborative effort of the PSG, Indiana University, and University of Cincinnati. With Tatiana Foroud, PhD (Indiana University) as Principal Investigator, this initiative seeks to identify the gene or genes that predispose an individual to develop Parkinson's disease. This project identifies and recruits individuals with PD who have a living or deceased parent, child, or sibling who has/had PD. In total about 1800 individuals' DNA will undergo genetic analysis. Coupled with occupational, environmental and other risk factor data, the genetic information is expected to improve pre-clinical detection of Parkinson's disease and thereby foster the development of more effective therapies. This project is currently seeking participants. For additional information please visit the PROGENI website.

FOUND Project: (FOllow-Up of Persons with Neurologic Diseases)
...Recruitment for FOUND is in progress (although this is not a clinical trial)...

The goal of the PSG (Parkinson Study Group) FOUND (Follow-up of Persons with Neurologic Diseases) project in this early phase is to come up with a method for future follow-up of clinical trial subjects after the end of the trial, by using simple methods. Subjects are being recruited from two trials, which include persons with early, mild disease. In the next phase of this study, clinic subjects with moderate and advanced disease and subjects from epidemiologic studies will also be included. The goals of the first phase was to enroll and retain 100% of the clinical trial subjects and to develop a well-organized method for maintaining contact with participants through use of self-report questionnaires mailed three times a year. This is mostly important in chronic diseases such as Parkinson’s disease where the disease may last for decades. We hope to learn of the similarities and differences between clinical trial participants and the entire population of persons with Parkinson’s disease (PD). Knowing that information on the later course of the disease is the hardest to get, an easy, low-cost method for getting important information is desirable. Making the study larger to include clinical subjects and subjects from epidemiologic studies allows us to look at how useful these forms are for subjects with more advanced disease.

NON-PSG STUDIES IN PROGRESS
Updated: July 22, 2009

PSP Patients and Caregivers Needed for NIH-Funded Study:
Genetic and Environmental Risk Factors for PSP Research Study

...Recruitment is in progress...

This large case/control study that will involve 500 PSP patients and 1000 controls will seek to determine if there is an association between PSP and specific gene deficits and will also explore whether there is an association between PSP and occupational and or environmental chemical exposures functionally or structurally similar to known parkinsonian toxicants.

We are currently seeking subjects who have been diagnosed with PSP and meet the following criteria:
o 40 years of age or older
o able to participate in a telephone interview
o can visit one of our screening sites
o have no other major neurological disorders
o can identify two healthy controls (a spouse or caregiver and an age and gender-matched, non-blood relative such as an in-law, friend or neighbor).

The subject involvement requires visiting one of our 9 screening sites:
o University of Louisville (Louisville, KY)
o Baylor College of Medicine (Houston, TX)
o Case Western Reserve (Cleveland, OH)
o Emory School of Medicine (Atlanta, GA)
o University of California, Los Angeles (Los Angeles, CA)
o University of Alabama, Birmingham (Birmingham, AL)
o University of Maryland (Baltimore, MD)
o University of Colorado (Denver, CO)
o University of Washington (Seattle, WA)

Anyone interested in participating should contact the University of Louisville Division of Movement Disorders at 1-866-PSP-0448 or http://www.pspstudy.com.

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Updated June 14, 2010
CLINICAL TRIALS IN PROGRESS

SPIN-PD: Spectroscopy in Parkinson Disease Diagnosis ...Recruitment for SPIN-PD is currently underway...

The Parkinson Study Group (PSG), under the direction of Anthony Lang, MD (Toronto Western University), and Bernard Ravina, MD, MSCE (University of Rochester), is conducting a multi-center observational study in individuals with Parkinson disease (PD). The purpose of the study is to assess the potential for biomarkers in diagnosis of PD and secondly, whether these biomarkers are predictors of disease progression. Approximately 37 research centers across North America will enroll up to 300 PD subjects and 200 Healthy Controls to be followed for 2 years. Biospectroscopy technologies are able to identify the presence of biomarkers in blood plasma. Previously Molecular Biometrics, Inc. has demonstrated these biomarkers could be used to distinguish PD subjects from normal elderly controls. The goal of this study is to expand on earlier studies to determine if this technique can serve as a quick, non-invasive method of early identification of PD or as a biomarker for PD progression (see reference: Schipper et al. Biomarkers Med. 2008:2(3);229-238). This study is being conducted with funds provided by Molecular Biometrics, Inc. made possible through grants from the Michael J. Fox Foundation and The National Institute of Neurological Disorders and Stroke. Dr. Hyman Schipper, Medical Director-Neuroscience, is the Company’s principal investigator for this study. If you are interested in learning more about this study, please contact the Parkinson Study Group toll free at 1-888-887-3774 or see the study on www.ClinicalTrials.gov.

SURE-PD (Safety and Ability to Elevate Urate in Early Parkinson’s Disease): A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral Inosine to Assess Safety and Ability to Elevate Urate in Early Parkinson's Disease ...Recruitment for SURE-PD is currently underway...

The SURE-PD study is being conducted by the Parkinson Study Group (PSG) under the direction of Principal Investigator Michael Schwarzschild, MD, PhD (Massachusetts General Hospital), Alberto Ascherio, MD, DRPH (Harvard School of Public Health), and Karl Kieburtz, MD, MPH (University of Rochester). The Michael J. Fox Foundation for Parkinson’s Research is funding the study. Urate, also known as uric acid, is a substance that is a normal part of human blood (serum) and cerebrospinal fluid (CSF). There is some recent evidence that urate levels might predict both the risk of PD and its worsening over time (progression). Higher levels of urate may be related to a slower decline in PD. However, there is a need to conduct a well-designed clinical trial to find out if higher urate and slower PD decline just happen to occur together, or if urate causes PD to slow down. Inosine, a nutritional supplement, is a substance that might be able to make such a clinical trial possible. When taken by mouth, inosine is absorbed by the body and changed into urate. Therefore, people who take inosine by mouth should be able to raise (elevate) the levels of urate in their bodies. But before we start a large study to see if inosine can change the progression of PD, it is best to find out in a smaller, pilot study some important things about inosine, about patient safety, and about the best research plan to answer our questions. Therefore, SURE-PD has several purposes. We will look at how safe inosine is in patients with early PD, and if it causes side effects. We will also see if inosine can raise urate levels in serum and in CSF in patients with early PD. This information will help us decide whether and how to proceed with a larger study of inosine’s ability to slow down the rate of worsening disability in PD. To participate in SURE-PD individuals must have at least two of the cardinal signs of PD (resting tremor, bradykinesia, rigidity), be age 30 or older at the time of PD diagnosis, have been diagnosed with PD within the past 3 years, and currently not be taking or needing any treatment for PD. Ninety participants will be enrolled at 11 sites across the U.S. and randomized to one of three treatment groups: 1) those who will receive placebo, 2) those who will receive inosine dosed to produce a mild elevation in urate levels, and 3) those who will receive inosine dosed to produce a moderate elevation in urate levels. Participants will be seen for two screening visits and then 14 visits over 25 months. If you are interested in learning more about this study, please contact the Parkinson Study Group toll free at 1-888-887-3774 or see the study on www.pdtrials.org www.ClinicalTrials.gov (NCT00833690) where the participating sites are listed.

STEADY-PD: Safety, Tolerability, and Efficacy Assessment of Dynacirc® CR for Parkinson's Disease ...Recruitment for STEADY-PD is currently underway...

The Parkinson Study Group (PSG), under the direction of Tanya Simuni, MD (Northwestern University), and Kevin Biglan, MD, MPH (University of Rochester), is conducting a multi-center, randomized, double-blind, placebo-controlled study of isradipine CR (Dynacirc® CR) in individuals with early Parkinson disease (PD) The purpose of the study is to assess the general safety and tolerability of isradipine CR, to determine effective dosage of isradipine CR and obtain pilot data on the potential effect of isradipine on slowing the progression of PD. Approximately 18 research centers across North America will enroll up to 100 subjects for 12 months each. Isradipine CR is a medication that is approved for the treatment of high blood pressure by the Food and Drug Administration Agency (FDA), but not for the treatment of PD. Isradipine CR has been shown to have a neuroprotective effect in preclinical models of parkinsonism (see reference: Simuni T, Martel A, Zadikoff C, Videnovic A, Vainio L, Weaver F, Williams K, Surmeier DJ. Safety and tolerability of isradipine, a dihydropyridine calcium channel blocker, in patients with early Parkinson’s disease. Abstract. Mov Disord 2008;23(11):1629). This study is being conducted under a research grant award from the Michael J. Fox Foundation (MJFF) and the Dixon Foundation. If you are interested in learning more about this study, please contact the Parkinson Study Group toll free at 1-888-887-3774 or see the study on www.ClinicalTrials.gov where the participating sites are listed.

Effects of Coenzyme Q10 in Parkinson Disease – Phase 3 (QE3) ...Recruitment for QE3 is in progress...

The Parkinson Study Group (PSG), under the direction of Principal Investigators Neurologist Flint Beal, MD (Weill Medical College of Cornell University) and Biostatistician David Oakes, PhD (University of Rochester) and Co-Principal Investigator Neurologist Ira Shoulson, MD (University of Rochester), is conducting a multi-center, randomized, double-blind, placebo-controlled study of Coenzyme Q10 (CoQ) in individuals with Parkinson disease. The objective of this study, called ‘QE3’, is to evaluate the safety and effectiveness of high dosages of CoQ in slowing clinical decline in patients who have early Parkinson disease. Current medications are able to treat many of the symptoms of Parkinson disease, but there is no treatment to slow disease progression. CoQ is a naturally occurring substance in the body and is also a nutritional supplement. The CoQ in this study, which will also contain vitamin E, is being studied as an investigational drug at higher dosages and, in previous studies, has been well tolerated with no serious safety issues reported. Participants 30 years of age or older, diagnosed with Parkinson disease within the last 5 years, and are not yet receiving symptomatic treatment may be eligible for the study. Study doctors will follow participants every four months over a 16 month period. Researchers at approximately 60 clinical sites in the United States and Canada will enroll a total of 600 research subjects with early signs of Parkinson disease. Each center will enroll approximately 10 participants. Enrollment began in January 2009. This study is sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH). If you are interested in learning more about this study, please contact the Parkinson Study Group toll free at 1-888-887-3774. This trial is also listed on ClinicalTrials.gov. For a list of participating centers, see the QE3 Participating Site List.

PROGENI: Parkinson's Research: The Organized GENetics Initiative ...Recruitment for PROGENI is in progress...To obtain additional information call 1-888-830-6299. Outside the United States, call 1-317-274-5734.

PROGENI (Parkinson's Research: The Organized GENetics Initiative) is a NIH-funded collaborative effort of the PSG, Indiana University, and University of Cincinnati. With Tatiana Foroud, PhD (Indiana University) as Principal Investigator, this initiative seeks to identify the gene or genes that predispose an individual to develop Parkinson's disease. This project identifies and recruits individuals with PD who have a living or deceased parent, child, or sibling who has/had PD. In total about 1800 individuals' DNA will undergo genetic analysis. Coupled with occupational, environmental and other risk factor data, the genetic information is expected to improve pre-clinical detection of Parkinson's disease and thereby foster the development of more effective therapies. This project is currently seeking participants. For additional information please visit the PROGENI website.