Drug Treatment Study for Parkinson’s Disease Patients With Off Episodes
Local doctors are currently conducting a medical research study to evaluate an investigational medication that is designed to quickly and effectively respond to off episodes. In this study, they want to learn more about the safety and effectiveness of the investigational medication when it is inhaled through a special inhaler device. Approximately 345 Parkinson’s disease (PD) subjects in the Unites States and Canada will take part in this study. If you agree to participate you will be one of up to 8 subjects to participate in this study at Rush University Medical Center. Participation in this study will last for up to 19 weeks and you will need to come in to the clinic for 6 or 7 visits to complete the study.
In order to participate you must meet the following criteria:
- Be between the ages of 30 and 80 years and diagnosed with Idiopathic Parkinson's Disease (PD).
- Have Hoehn and Yahr Stage 1-3 in an "on" state.
- Require levodopa-containing medication regimen at least 4 times during the waking day.
- Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness.
You will be excluded from the study if any of the following criteria apply to you:
- Are pregnant or lactating.
- Have had previous surgery for PD or plan to have stereotactic surgery during the study period.
- Have a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year.
- Have a known contraindication to the use of levodopa.
This is a partial list of inclusion and exclusion criteria.