Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease
