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

Launched by ABBVIE · Nov 19, 2015

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Eligibility criteria

• 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.
• • 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.
• 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 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