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

Study Identifier
P14-494
CT.gov Identifier
NCT02611713
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Parkinson's Disease
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham - Main /ID# 144422
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Parkinson's Disease and Moveme /ID# 144413
    Boca Raton, Florida, United States, 33486
    Status
    Not applicable
    Location
    University of Florida - Archer /ID# 144415
    Gainesville, Florida, United States, 32610
    Status
    Not applicable
    Location
    University of Miami /ID# 144420
    Miami, Florida, United States, 33138
    Status
    Not applicable
    Location
    Georgia Regents University /ID# 144417
    Augusta, Georgia, United States, 30912
    Status
    Not applicable
    Location
    University of Kansas Health Sy /ID# 154242
    Kansas City, Kansas, United States, 66160-8500
    Status
    Not applicable
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