N/A
Completed N=148
Global REsponsE During iNFusIon of a gEl With LevoDopa/Carbidopa
Source: ClinicalTrials.gov NCT01754129 ↗Enrolled (actual)
148
Serious AEs
27.6%
Results posted
Aug 2018
Primary outcomePrimary: Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Proportion of Waking Day Spent in "Off") Score: Mean Change From Baseline to the Last Available Follow up — -0.97; -1.04 units on a scale — p=<0.001
Summary
This multicenter, post marketing observational study (PMOS) was designed to evaluate the long-term effectiveness of levodopa/carbidopa intestinal gel (DUODOPA) on motor fluctuations (duration of OFF periods) in participants with advanced levodopa-responsive Parkinson's disease (PD) and severe motor fluctuations and hyper-/dyskinesia (involuntary movements). Secondary objectives of this study were to assess the participants' quality of life; to assess the long-term safety of DUODOPA; to assess disability, cognitive function, and non-professional caregiver burden; and to assess the economic and social impact of family caregiver assistance.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Proportion of Waking Day Spent in "Off") Score: Mean Change From Baseline to the Last Available Follow up |
-0.97; -1.04 | <0.001 sig |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Part A+B Score: Mean Change From Baseline to Visits 2 and 3 |
-3.33; -3.08 | — |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale on Mentation, Behavior and Mood (UPDRS I) and Activities of Daily Living (UPDRS II) During On and Off Phases |
-0.49; -0.21; -0.83; -0.92; -2.42; -1.48 | — |
| SECONDARY Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) Scores |
-2.70; -0.09 | — |
| SECONDARY Change in Parkinson's Disease Sleep Scale Version 2 (PDSS-2) Scores |
-1.19; -0.95 | — |
| SECONDARY Change in Gait and Falls Questionnaire (GFQ) Scores |
-1.70; -0.81 | — |
| SECONDARY Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Scores |
-1.62; -2.02 | — |
| SECONDARY Economic and Social Impact of Family-provided Healthcare |
51; 52.4; 53; 23.6; 21.3; 21.7 | — |
| SECONDARY Change in Relative Stress Scale (RSS) Scores |
-0.20; 0.09 | — |
| SECONDARY Concomitant Diseases and Medications |
34; 22; 9; 11; 8; 11 | — |
| SECONDARY Change in Global Effectiveness on Motor Symptoms as Compared to Baseline |
3; 7; 5; 2; 13; 22 | — |
| SECONDARY Participant Self-assessment Scale of DUODOPA Therapy |
7.1; 7.1; 7.0 | — |
| SECONDARY DUODOPA Total Daily Infusion Dosage |
56.37; 56.61; 58.91; 58.8 | — |
Eligibility Criteria
Inclusion Criteria
- Participants already on treatment with DUODOPA (having already concluded the naso-intestinal treatment phase) according to the local DUODOPA product label and to routine clinical care for advanced PD patients
- Participants with available data on DUODOPA treatment, on previous PD conventional treatments and with at least one of the scales/questionnaires under study already collected on the participant's clinical chart
- Participant or legal representative has given written informed consent
- Non-professional caregiver (relative or familiar who give daily assistance to the patient) has given his/her written consent
Exclusion Criteria
- History or presence of any condition that might interfere with the long-term continuation of the duodenal infusion of DUODOPA
Data sourced from ClinicalTrials.gov (NCT01754129). 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.