Abstract

The purpose of this study is to compare a dopamine agonist pramipexole with carbidopa-levodopa in the initial treatment of early, symptomatic Parkinson's disease. Parkinson's disease is a very difficult to treat neurodegenerative syndrome and carbidopa-levodopa, a mainstay of treatment, is associated with adverse neurologic reactions. This is a multi-center, randomized, double-blind, parellel, placebo-controlled trial of a total of 300 patients to compare the 2 therapies. The primary outcome measure is the time until the first dopaminergic motor complication, and secondary measures include quality of life and the requirement for supplemental study drug and additional carbidopa-levodopa. Recruitment is completed. Data analysis is not completed in this multi-center clinical trial. The protocol is amended to allow those subjects participating in the accompanying SPECT Imaging study M/2730/0096 to have the final imaging procedure accomplished prior to the study drug being discontinued at the termination of the trial.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR001066-23
Application #
6308067
Study Section
Project Start
1999-12-01
Project End
2000-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
23
Fiscal Year
2000
Total Cost
$575
Indirect Cost

  Institution

Name
Massachusetts General Hospital
Department
Type
DUNS #
City
Boston
State
MA
Country
United States
Zip Code
02199

  Publications

Kelsey, Megan M; Braffett, Barbara H; Geffner, Mitchell E et al. (2018) Menstrual Dysfunction in Girls From the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study. J Clin Endocrinol Metab 103:2309-2318
Kleinberger, Jeffrey W; Copeland, Kenneth C; Gandica, Rachelle G et al. (2018) Monogenic diabetes in overweight and obese youth diagnosed with type 2 diabetes: the TODAY clinical trial. Genet Med 20:583-590
Fourman, Lindsay T; Czerwonka, Natalia; Shaikh, Sofia D et al. (2018) Insulin-like growth factor 1 inversely relates to monocyte/macrophage activation markers in HIV. AIDS 32:927-932
Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J et al. (2018) Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial. Pediatr Diabetes 19:191-198
Arslanian, Silva; El Ghormli, Laure; Kim, Joon Young et al. (2018) The Shape of the Glucose Response Curve During an Oral Glucose Tolerance Test: Forerunner of Heightened Glycemic Failure Rates and Accelerated Decline in ?-Cell Function in TODAY. Diabetes Care :
Kriska, Andrea; El Ghormli, Laure; Copeland, Kenneth C et al. (2018) Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes. Pediatr Diabetes 19:36-44
Venditti, E M; Tan, K; Chang, N et al. (2018) Barriers and strategies for oral medication adherence among children and adolescents with Type 2 diabetes. Diabetes Res Clin Pract 139:24-31
Foldyna, Borek; Fourman, Lindsay T; Lu, Michael T et al. (2018) Sex Differences in Subclinical Coronary Atherosclerotic Plaque Among Individuals With HIV on Antiretroviral Therapy. J Acquir Immune Defic Syndr 78:421-428
Gidding, Samuel S; Bacha, Fida; Bjornstad, Petter et al. (2018) Cardiac Biomarkers in Youth with Type 2 Diabetes Mellitus: Results from the TODAY Study. J Pediatr 192:86-92.e5
Srinivasa, Suman; Lu, Michael T; Fitch, Kathleen V et al. (2018) Epicardial adipose tissue volume and cardiovascular risk indices among asymptomatic women with and without HIV. Antivir Ther 23:1-9

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