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

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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
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20
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Grand Rapids, Michigan 49503
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Grand Rapids, MI
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Augusta, GA
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Baltimore, Maryland 21287
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Baltimore, MD
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Birmingham, Alabama 35233
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Birmingham, AL
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Boca Raton, Florida 33486
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Boca Raton, FL
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Burlington, VT
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Concord,
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Gainesville, Florida 32607
2100
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Gainesville, FL
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Hershey, Pennsylvania 17033
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Hershey, PA
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Kansas City, Missouri 66160
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Kansas City, MO
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Kirkland, Washington 98034
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Kirkland, WA
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Lexington, KY
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Miami, Florida 33136
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Miami, FL
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1215 21st Avenue South
Nashville, Tennessee 37232
1762
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Nashville, TN
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1298
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Omaha, NE
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Philadelphia, Pennsylvania 19107
2373
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Philadelphia, PA
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660 South Euclid Avenue
Saint Louis, Missouri 63110
1569
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Saint Louis, MO
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Spokane, Washington 99202
939
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Spokane, WA
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3801 South National Avenue
Springfield, Missouri 65804
1401
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Springfield, MO
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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