Advanced Parkinsons

Clinical Trial Title Advanced Parkinsons
Trial Status Open to Enrollment
Start Date 05/01/2019
Location Doctors & Locations
Trial Type Parkinson's Disease
Specific Condition Advanced Parkinsons
Description

 This is a 52-week, Phase 3, open-label, single-arm, multicenter study to assess the local and systemic safety and tolerability, as well as efficacy, of ABBV-951 administered as a continuous subcutaneous infusion (CSCI) for 24 hours daily for up to 52 weeks.

ABBV-951 enables continuous, subcutaneous, and individualized delivery of carbidopa/levodopa (CD/LD), covering the wide range of levodopa doses required to adequately control motor symptoms in patients with advanced PD. Therefore, this novel treatment may provide an alternative therapy to many patients whose motor complications are inadequately controlled by their current treatment.

The investigational product consists of study drug (solution for infusion) and study devices.

Subjects will have 11 study visits in the treatment period over 52 weeks
Eligibility Criteria
Ages Eligible for Study:  30 years and older

Sexes Eligible for Study:  All

Criteria

Inclusion Criteria:

  • Subjects with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa -responsive
  • Subjects must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day
IRB Number 10826
Notes
Principal Investigator Richard Rosenbaum, MD
Contact Name Tammy Mayfiel@lhs.org
Contact Phone 503-413-7945
Contact Fax 50-413-6861
Contact E-Mail tmayfiel@lhs.org