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Advanced Parkinsons

Trial

Clinical Trial Title

Advanced Parkinsons

Trial Status

Open to Enrollment

Start Date

May 1, 2019

Location

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

Principal Investigator Name

Richard Rosenbaum, MD

Contact Name

Tammy Mayfiel@lhs.org

Phone

503-413-7945

Contact Fax

50-413-6861

Contact E-Mail

tmayfiel@lhs.org

Last Updated: Thursday, November 7, 2019 03:49:53 PM