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8110 Gatehouse Road, Falls Church, VA 22042

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)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

H20-012

Background Information

There is limited data available on the clinical outcomes and disease burden of patients who are experiencing motor fluctuations not adequately controlled by current PD medications. Data from a real-world setting in this patient population will help to understand the disease burden and its evolution over time, and the impact of advanced therapies.

Offered At

Inova Medical Group – Neurology
8081 Innovation Park Dr., #900
Fairfax, VA 22031

Eligibility Information

  • Adults ≥ 30 years of age
  • Participants with a diagnosis of idiopathic PD that is levodopa –responsive
  • Participants must be judged by the investigator to have had an adequate trial of available oral PD medications and to be inadequately controlled by current therapy, have a minimum of 2.5 hours of "Off" time per day
  • Must have a recognizable/identifiable "Off" and "On" state (motor fluctuations) as established through investigator observation and confirmed by self-report recorded at the baseline visit

Ineligibility Information

  • Atypical parkinsonism
  • A recent (within 6 months prior to study inclusion) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator
  • A history or presence of psychotic episodes that in the investigator's judgment are not adequately controlled
  • Clinically significant unstable medical conditions or any other reason that the investigator determines would interfere with the subject's participation in this study
  • Participating in any other interventional clinical study