N/A
Completed N=409
COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel
Parkinson's Disease (PD)
Source: ClinicalTrials.gov NCT03362879 ↗
Enrolled (actual)
409
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months — 29.3; 52.3 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months |
29.3; 52.3 | — |
| SECONDARY Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation |
35.0; 23.8; 7.3; 15.4; 13.8; 11.5 | — |
| SECONDARY Total Daily Dose (in Milliliters) of LCIG Infusion at 12 Months After LCIG Initiation |
69.2 | — |
| SECONDARY Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants |
372; 6; 16; 5; 10 | — |
| SECONDARY HCRU: Caregiver Support by Number of Participants |
160; 83; 96; 5; 65 | — |
| SECONDARY Percentage of Physicians With Overall Preference for LCIG Monotherapy |
71.4; 28.6 | — |
| SECONDARY Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation) |
0.842; 1.564; 0.974 | — |
| SECONDARY Predictors for Monotherapy (Physician Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation) |
2.760; 1.000 | — |
| SECONDARY Duration (Days) of LCIG Monotherapy 1 or Monotherapy 2 |
932.6; 945.1 | — |
| SECONDARY Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country |
111.7; 283.2; 298.9; 387.4; 343.2; 460.8 | — |
| SECONDARY Time (Days) From Initial LCIG Administration to Substantial Dose Adjustment |
409.2 | — |
| SECONDARY Days From Initial LCIG Administration to the Initiation of LCIG Monotherapy |
89.5; 70.4 | — |
| SECONDARY Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication |
21.3; 34.0; 21.0; 9.0; 34.3; 24.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03362879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.