Parkinson's
Conditions
Interventions
foslevodopa/foscarbidopa (LDp/CDp), Duodopa subcutaneous 
Sponsors
AbbVie B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: See pages 21/22 of the protocol:Eligibility for LDp/CDp therapy in accordance with approved local label in the participating country and local reimbursement regulations, if applicableA diagnosis of levodopa-responsive idiopathic PDAdult male or female between 18 and 69 years of ageDisease duration (time since diagnosis) <10 yearsTime since motor fluctuations =5 yearsH&Y Stage <3 in best “on”“off”time of =4.5 hours per dayNaïve to LDp/CDpTreatment has been optimized with oral/transdermal PD medication in the opinion of the InvestigatorDecision to treat with LDp/CDp made by the clinician prior to any decision to approach the patient to participate in the studyWilling and able to comply with procedures required during this study, specifically with entering data and filling questionnaires in an electronic device (ipad).Prior to any study-related procedures being performed, the patient must voluntarily sign an ICF according to national regulations once the study has been explained and the patient has the opportunity to have any questions answered
Exclusion criteria
Exclusion criteria: See page 22/23 of the protocol:Any condition included in the contraindications section of the approved localLDp/CDp label in the participating countryHistory of treatment with any DAT, such as DBS, CSAI, LCIG/CLES, LECIGMMSE score <24Participation in a concurrent investigational or observational clinical trialLack of motivation/insufficient language skills to complete the study questionnairesHistory of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis). In case of temporary affections like recent sunburn or open wounds, or in case of permanent affections like acne, scar tissue, tattoo, branding, or colorations, the patient should not be included if the Investigator considers these as interfering with infusion of study drug or study assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for the study is the change from baseline to Month 6 in motor complications, as measured by the MDS-UPDRS Part IV subscore. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints Change from baseline to Month 6 in “Off” time duration (absolute hours) and severity, as measured by the modified MDS-UPDRS Part IV, Item 4.3 and 4.4 scores Change from baseline to Month 6 in dyskinesia presence, impairment and disability, as measured by the UDysRS total score Change from baseline to Month 6 in dyskinesia duration (absolute hours) and severity, as measured by the modified MDS-UPDRS Part IV, Item 4.1 and 4.2 scores Change from baseline to Month 6 in disease-specific QoL, as measured by the PDQ-39 summary index Change from baseline to Month 6 in generic QoL, as measured by the EQ-5D-5L and EQ-VAS scores Change from baseline to Month 6 in motor experiences of daily living, as measured by the MDS-UPDRS II subscore Change from baseline to Month 6 in disease-specific sleep disturbances, as measured by the PDSS-2 total score Change from baseline to Month 6 in patient-reported symptom severity, as measured by the PGI-S questionnaire Change from baseline to Month 6 in clinician-reported symptom severity, as measured by the CGI-S questionnaire Patient-reported symptom change, as measured by the PGI-C questionnaire Clinician-reported symptom change, as measured by the CGI-C questionnaire | — |
Countries
Australia, Canada, Croatia, Israel, Netherlands, Romania, Spain, United Kingdom, United States
Contacts
Public ContactK. Kuijl
AbbVie B.V.
Outcome results
None listed