Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease

Completed

Conditions studied: Advanced Parkinson's Disease

In brief

This study is a non-interventional post-marketing observational study (PMOS) of participants with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical setting. Effectiveness of treatment will be collected with physician and participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at the start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6 months thereafter up to 36 months. An additional cohort of participants will be enrolled who in addition will be evaluated with a wearable device.

Key facts

Study ID

NCT02611713

Run by

AbbVie

People needed

213

Starts

2016-01-04

Expected to finish

2020-12-24

Last updated by the study team

2021-12-15

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligibility for Duodopa/Duopa therapy in accordance with the approved local Duodopa/Duopa label in the participating country.
• Duodopa/Duopa naïve participants
• Decision to treat with Duodopa/Duopa made by the physician prior to any decision to approach the participant to participate in this study
• Prior to any study-related procedures being performed, the participant, or legal authorized representative (LAR) has voluntarily signed an Authorization for Use/Disclosure of Data (AUDD)/informed consent form (ICF) according to national regulations after the study has been explained and the subject has had the opportunity to have questions answered.
• For Arm B: Participant and caregiver must be motivated to use the PKG, understand the instructions and be able to handle the device.
• For Arm B: participant must demonstrate at least 75% concordance with the investigator's or qualified designee's assessment of symptoms on the Parkinson's disease diary following training at enrollment visit 1/V1 with concordance on at least 1 time interval of "Off", concordance on at least 1 time interval of "ON regardless of dyskinesia" and at least 1 time interval of "ON with dyskinesia" irrespective of whether the dyskinesia are troublesome or not troublesome.

You may not qualify if…

• Any condition included in the contraindications section of the approved local Duodopa/Duopa label in the participating country.
• Participants who have had previous surgery for PD including, but not limited to deep brain stimulation (DBS) or cell transplantation (this criterion removed for US sites for Arm A).
• Participants currently in treatment with continuous apomorphine infusion. In case of a previous treatment with continuous subcutaneous apomorphine infusion, there must be at least 4 weeks between discontinuation of this treatment and inclusion into this study.
• Mini-Mental State Examination (MMSE) score <24
• Participation in a concurrent interventional clinical trial.
• Lack of motivation or insufficient language skills to complete the study questionnaires

Where it is running

• Parkinson's Disease and Moveme /ID# 144413 — Boca Raton, Florida, United States
• University of Florida - Archer /ID# 144415 — Gainesville, Florida, United States
• University of Miami /ID# 144420 — Miami, Florida, United States
• Georgia Regents University /ID# 144417 — Augusta, Georgia, United States
• University of Kansas Health Sy /ID# 154242 — Kansas City, Kansas, United States
• University of Kentucky Chandler Medical Center /ID# 144421 — Lexington, Kentucky, United States
• Johns Hopkins University /ID# 144416 — Baltimore, Maryland, United States
• Mercy St. Mary's Health Center /ID# 144418 — Grand Rapids, Michigan, United States
• Jared Neuroscience Center /ID# 161629 — Springfield, Missouri, United States
• Washington University-School of Medicine /ID# 147235 — St Louis, Missouri, United States
• Univ Nebraska Med Ctr /ID# 147655 — Omaha, Nebraska, United States
• Wake Forest Univ HS /ID# 144419 — Winston-Salem, North Carolina, United States
• Penn State Child Hosp.Hersh,PA /ID# 160671 — Hershey, Pennsylvania, United States
• University of Pennsylvania /ID# 161135 — Philadelphia, Pennsylvania, United States
• Vanderbilt Univ Med Ctr /ID# 150782 — Nashville, Tennessee, United States
• University of Vermont Medical Center /ID# 144410 — Burlington, Vermont, United States
• King County Public Hospital /ID# 144412 — Kirkland, Washington, United States
• Northwest Neurological, PLLC /ID# 144409 — Spokane, Washington, United States
• Concord Repatriation & Gen Hos /ID# 144373 — Concord, New South Wales, Australia
• St. Vincent's Hospital, Darlinghurst /ID# 144376 — Darlinghurst, New South Wales, Australia
• Kingston Centre /ID# 144374 — Cheltenham, Victoria, Australia
• Monash Medical Centre /ID# 144375 — Clayton, Victoria, Australia
• UZ Antwerp /ID# 144378 — Edegem, Belgium
• AZ Groeninge /ID# 144377 — Kortrijk, Belgium
• University of Alabama at Birmingham - Main /ID# 144422 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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