A prospective observational study to evaluate the clinical outcomes and burden of disease of PD patients with motor fluctuations not adequately controlled by current PD medications (PROSPECT)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective observational study

Study drug and medical condition

• Medical condition to be studied:
  Parkinson's disease

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  550

Study design details

• Main study objective:
  The objective of this observational study is to describe the clinical outcomes and disease burden of advancing PD disease in PD patients with motor fluctuations no longer controlled by current PD medications.
• Outcomes:
  Change of Off time from baseline to 24 months as measured by PD diary. Change in Off time from baseline to 12 monthsChange in dyskinesia from baseline to 12 and 24 monthsChange in HY Stage (in ON and OFF state) from baseline to 12 and 24 monthsChange in EQ5D5L patient and caregiver Total score from baseline to 12 and 24 monthsChange in MDS UPDRS part II score from baseline to 12 and 24 monthsChange in NMSS Total score from baseline to 12 and 24 months
• Data analysis plan:
  Descriptive statistics will be used to summarize all endpoints. Continuous endpoints will be summarized using number of missing and non-missing observations, mean, median, minimum, maximum, standard deviation and 95% confidence interval. Categorical values will be summarized as the number of patients and percentages (%) of patients in each category.