CLINICAL TRIALS IN PROGRESS Updated: June 11, 2008
PramiBID:  A Randomized, Double-Blind, Active (Pramipexole 0.5 mg tid) and placebo controlled, efficacy study of pramipexole given 0.5 mg and 0.75 mg bid over a 12-week treatment phase in early Parkinson’s disease patients ...Recruitment for PramiBID is now complete...
The Parkinson Study Group (PSG), in collaboration with Boehringer Ingelheim Pharmaceuticals, (Inc. Ridgefield, CT), is conducting this study for patients with early Parkinson’s disease.  Participants must be over 30 years of age, diagnosed less than 7 years ago, and not be treated with dopaminergic medications such as carbidopa/levodopa or dopamine agonists. Medications such as amantadine, MAO-B inhibitors, and anticholingerics are permitted. The purpose of the PramiBID study is to see how well low doses of pramipexole (Mirapex®) work for patients with early PD when these low doses are taken two times per day. Typically pramipexole is taken at higher doses three times per day. This study will also look at how pramipexole affects mood, thinking, impulse control, fatigue, daytime sleepiness and night time sleep. Participants will be in the study for a total of about 14 weeks. Approximately 300 individuals are being enrolled at about 50 PSG centers in the United States. Enrollment began in December 2006 and was completed on June 5, 2008.   For a list of centers offering this study, see the PramiBID Participating Site List.  If you have difficulty reaching the center nearest you, please call the Parkinson Study Group toll free at 1-888-887-3774.
PROGENI: Parkinson's Research: The Organized GENetics Initiative ....Recruitment for PROGENI is now 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.

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