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

AbbVie

Status: Completed

Conditions: Advanced Parkinson's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02611713

P14-494

Details and patient eligibility

About

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.

Enrollment: 213 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

213 participants in 2 patient groups

Arm A: Participants with Advanced Parkinson's Disease

Description:

Participants who along with their physicians have elected for treatment with Duodopa/Duopa and are prescribed according to the local product label and reimbursement guidelines for their participating countries.

Arm B: Participants with Advanced Parkinson's Disease

Description:

Participants who along with their physicians have elected for treatment with Duodopa/Duopa and are prescribed according to the local product label and reimbursement guidelines for their participating countries. Participants will be evaluated with a wearable device