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

Status:	Active, not recruiting
Conditions:	Parkinsons Disease
Therapuetic Areas:	Neurology
Healthy:	No
Age Range:	18 - 99
Updated:	10/18/2018
Start Date:	January 4, 2016
End Date:	March 27, 2021

DUOdopa/Duopa in Patients With Advanced Parkinson's Disease (PD) - a GLobal Observational Study Evaluating Long-Term Effectiveness (DUOGLOBE)

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).

- 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

We found this trial at

sites

University of Pennsylvania /ID# 161135

Philadelphia, Pennsylvania 19107

from

Philadelphia, PA