DUOdopa/Duopa in Patients With Advanced Parkinson's Disease (PD) - a GLobal Observational Study Evaluating Long-Term Effectiveness (DUOGLOBE)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Parkinson's Disease
- Sponsor
- AbbVie
- Enrollment
- 213
- Locations
- 54
- Primary Endpoint
- Change in Duration of OFF time (hours/day) in Arm B
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
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
Outcomes
Primary Outcomes
Change in Duration of OFF time (hours/day) in Arm B
Time Frame: Baseline visit (Enrollment) to month 6
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 6 months) in OFF time duration as reported by participant with PD Diary both per full 24 hours and for the time period of 09:00 - 18:00
Duration of bradykinesia score above target in Arm B
Time Frame: Baseline visit (Enrollment) to month 6
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 6 months) in duration of bradykinesia score above target between 09:00 - 18:00 and for the full 24 hours per day (measured by Parkinson's KinetiGraph ( PKG))
Average bradykinesia score in Arm B
Time Frame: Baseline visit (Enrollment) to month 6
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 6 months) in average bradykinesia score (measured by PKG)
Change in the number of hours spent in OFF time in Arm A
Time Frame: Baseline visit (Enrollment) to month 36
Assess the effectiveness of Duodopa/Duopa treatment on OFF time measured by the change (from baseline to 36 months) in the number of hours spent in OFF time as reported by the participant for the day prior to the clinical visit.
Secondary Outcomes
- Change in Disease-Specific Sleep Quality in Arm A(Baseline visit (Enrollment) to month 36)
- Change in Motor Function in Arm A(Baseline visit (Enrollment) to month 36)
- Change in Generic Quality of Life in Arm A(Baseline visit (Enrollment) to month 36)
- Change in Disease-Specific Caregiver Burden in Arm A(Baseline visit (Enrollment) to month 36)
- Change in the Duration of Dyskinesia in Arm A(Baseline visit (Enrollment) to month 36)
- Change in Tremor Severity in Arm A(Baseline visit (Enrollment) to month 36)
- Change in Daytime Sleepiness in Arm A(Baseline visit (Enrollment) to month 36)
- Change in Activities of Daily Living in Arm A(Baseline visit (Enrollment) to month 36)
- Correlation of non-motor and motor improvements with Quality of Life improvements in Arm A(Baseline visit (Enrollment) to month 36)
- Correlation between duration of OFF time measured by UPDRS IV and duration of bradykinesia score above target in Arm B(Baseline visit (Enrollment) to month 6)
- Change in Disease-Specific Quality of Life in Arm A(Baseline visit (Enrollment) to month 36)
- Correlation between duration of OFF time measured by patient with PD Diary and duration of bradykinesia score above target in Arm B(Baseline visit (Enrollment) to month 6)
- Motor symptoms in Arm B(Baseline visit (Enrollment) to month 6)
- Change in Dyskinesia Severity in Arm A(Baseline visit (Enrollment) to month 36)
- Change in Overall Clinical Impression of Disease Severity in Arm A(Baseline visit (Enrollment) to month 36)
- Change in OFF Time Duration in Arm A(Baseline visit (Enrollment) to month 36)
- Correlation between duration of bradykinesia score above target and average bradykinesia score in Arm B(Baseline visit (Enrollment) to month 6)
- Correlation between duration of OFF time measured by UPDRS IV and average bradykinesia score in Arm B(Baseline visit (Enrollment) to month 6)
- Severity of tremor in Arm B(Baseline visit (Enrollment) to month 6)
- Change in Non-Motor Symptoms in Arm A(Baseline visit (Enrollment) to month 36)
- Change in Healthcare Resource Utilization in Arm A(Baseline visit (Enrollment) to month 36)
- Correlation between duration of OFF time measured by patient with PD Diary and average bradykinesia score in Arm B(Baseline visit (Enrollment) to month 6)
- Sleep in Arm B(Baseline visit (Enrollment) to month 6)
- Change in Complications of Therapy in Arm A(Baseline visit (Enrollment) to month 36)
- Correlation between duration of dyskinesia and Unified Dyskinesia Rating Scale (UDysRS) in Arm B(Baseline visit (Enrollment) to month 6)
- Severity of dyskinesia in Arm B(Baseline visit (Enrollment) to month 6)
- Activities of Daily Living (ADL) in Arm B(Baseline visit (Enrollment) to month 6)
- Daytime sleepiness in Arm B(Baseline visit (Enrollment) to month 6)
- Quality of Life (QoL) in Arm B(Baseline visit (Enrollment) to month 6)