COSMOS - COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 412
- Locations
- 30
- Primary Endpoint
- Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months
Study Overview
Brief Summary
The purpose of this study is to evaluate treatment of advanced Parkinson's Disease (PD) patients on levodopa-carbidopa intestinal gel (LCIG) monotherapy in a routine clinical setting.
Detailed Description
Participants with advanced Parkinson's Disease who have been prescribed LCIG for at least 12 months will be entered into the study cohort. Clinical data will be collected by retrospective review of the participant's medical records as well as a single study visit for current data. Treatment of the participants and follow up will be according to the physician's judgment, regional regulations and the product monograph.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants diagnosed with APD and on LCIG treatment for at least 12 months
- •Participant must have been on continuous LCIG treatment for at least 80% of days in the preceding year
- •Participants must be treated by the same physician (principal investigator or co-investigator) since the initiation of LCIG treatment
Exclusion Criteria
- •Participation in a concurrent or a previous interventional clinical trial during which the participant was on LCIG therapy
- •Lack of motivation or insufficient language skills to complete the study questionnaires
Outcomes
Primary Outcomes
Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months
Time Frame: 12 months
The percentage of participants on LCIG monotherapy from immediately following LCIG initiation to 12 months. LCIG monotherapy means that the participant is not on any add-on Parkinson's (PD) medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2).
Secondary Outcomes
- Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)(12 months)
- Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country(12 months)
- Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication(12 months)
- Total Daily Dose (in Milliliters) of LCIG Infusion at 12 Months After LCIG Initiation(12 months)
- HCRU: Caregiver Support by Number of Participants(12 months)
- Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation(12 months)
- Duration (Days) of LCIG Monotherapy 1 or Monotherapy 2(12 months)
- Time (Days) From Initial LCIG Administration to Substantial Dose Adjustment(12 months)
- Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants(12 months)
- Percentage of Physicians With Overall Preference for LCIG Monotherapy(12 months)
- Predictors for Monotherapy (Physician Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)(12 months)
- Days From Initial LCIG Administration to the Initiation of LCIG Monotherapy(12 months)