Phase 4
Completed N=77
Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact
Advanced Idiopathic Parkinson's Disease
Source: ClinicalTrials.gov NCT00141518 ↗
Enrolled (actual)
77
Serious AEs
72.4%
Results posted
Jul 2016
Primary outcomePrimary: Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 — 52.1; NA; NA; 42.5 units on a scale — p=0.017
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study is to collect health economic data depicting the initial levels and natural progression over time of resource usage, Parkinson's disease (PD)-related costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients treated with Duodopa (levodopa-carbidopa in an intestinal gel formulation), of which about one-third were Duodopa-naïve prior to the start of the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 |
52.1; NA; NA; 42.5; 44.0; 48.2 | 0.017 sig |
| PRIMARY Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12 |
0.57; NA; NA; 0.59; 0.66; 0.51 | 0.919 |
| PRIMARY EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12 |
0.44; NA; NA; 0.63; 0.64; 0.64 | 0.002 sig |
| PRIMARY Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010 |
78418; 75521; 82177; 78464 | — |
| PRIMARY Monthly Drug Costs Per Participant, SEK 2010 |
39382; 34417; 37679; 37339 | — |
| PRIMARY Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010 |
3825; 4552; 3607; 4002 | — |
| PRIMARY Direct Monthly Non-medical Costs Per Participant, SEK 2010 |
19274; 27439; 25008; 23398 | — |
| PRIMARY Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 |
17032; 14109; 14109; 13896; 14543; 14543 | — |
| SECONDARY Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 |
2.7; NA; NA; 2.5; 2.7; 3.2 | — |
| SECONDARY Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 |
2.2; NA; NA; 2.0; 2.5; 2.5 | — |
| SECONDARY Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 |
3.8; NA; NA; 3.6; 3.7; 4.0 | — |
| SECONDARY Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36 |
74.4; NA; NA; 80.4; 75.5; 74.4 | — |
| SECONDARY Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 |
28.2; NA; NA; 27.8; 28.0; 28.2 | — |
| SECONDARY MMSE Orientation Subscale Scores From Baseline to Month 36 |
9.8; NA; NA; 9.6; 9.9; 9.8 | — |
| SECONDARY MMSE Registration Subscale Scores From Baseline to Month 36 |
3.0; NA; NA; 3.0; 3.0; 3.0 | — |
| SECONDARY MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 |
4.9; NA; NA; 4.6; 4.4; 4.6 | — |
| SECONDARY MMSE Recall Subscale Scores From Baseline to Month 36 |
2.2; NA; NA; 2.2; 2.1; 2.3 | — |
| SECONDARY MMSE Language Subscale Scores From Baseline to Month 36 |
8.3; NA; NA; 8.5; 8.6; 8.5 | — |
| SECONDARY Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 |
10.3; NA; NA; 9.0; 7.8; 8.8 | — |
| SECONDARY MADRS Reported Sadness Scores From Baseline to Month 36 |
0.9; NA; NA; 0.6; 0.8; 0.8 | — |
| SECONDARY MADRS Apparent Sadness Scores From Baseline to Month 36 |
0.7; NA; NA; 0.4; 0.5; 0.8 | — |
| SECONDARY MADRS Inner Tension Scores From Baseline to Month 36 |
1.3; NA; NA; 1.3; 1.0; 0.9 | — |
| SECONDARY MADRS Reduced Sleep Scores From Baseline to Month 36 |
2.5; NA; NA; 1.9; 1.5; 1.7 | — |
| SECONDARY MADRS Reduced Appetite Scores From Baseline to Month 36 |
0.8; NA; NA; 0.6; 0.2; 0.3 | — |
| SECONDARY MADRS Concentration Difficulties Scores From Baseline to Month 36 |
1.0; NA; NA; 1.0; 1.5; 0.9 | — |
| SECONDARY MADRS Lassitude Scores From Baseline to Month 36 |
1.3; NA; NA; 1.4; 1.4; 1.7 | — |
| SECONDARY MADRS Inability to Feel Scores From Baseline to Month 36 |
0.5; NA; NA; 0.4; 0.2; 0.8 | — |
| SECONDARY MADRS Pessimistic Thoughts Scores From Baseline to Month 36 |
0.9; NA; NA; 1.0; 0.5; 0.6 | — |
| SECONDARY MADRS Suicidal Thoughts Scores From Baseline to Month 36 |
0.4; NA; NA; 0.5; 0.2; 0.3 | — |
| SECONDARY Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 |
33.6; NA; NA; 27.1; 30.3; 36.6 | 0.001 sig |
| SECONDARY PDQ-39 Mobility Subscale Scores From Baseline to Month 36 |
55.7; NA; NA; 38.8; 43.9; 53.3 | — |
| SECONDARY PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 |
38.7; NA; NA; 32.1; 40.8; 46.5 | — |
| SECONDARY PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 |
35.3; NA; NA; 30.9; 27.1; 37.7 | — |
| SECONDARY PDQ-39 Stigma Subscale Scores From Baseline to Month 36 |
24.8; NA; NA; 16.2; 16.5; 22.9 | — |
| SECONDARY PDQ-39 Social Support Subscale Scores From Baseline to Month 36 |
8.3; NA; NA; 10.3; 12.9; 22.1 | — |
| SECONDARY PDQ-39 Cognition Subscale Scores From Baseline to Month 36 |
30.6; NA; NA; 22.5; 33.0; 33.7 | — |
| SECONDARY PDQ-39 Communication Subscale Scores From Baseline to Month 36 |
32.4; NA; NA; 24.1; 27.3; 35.2 | — |
| SECONDARY PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 |
42.6; NA; NA; 41.7; 40.2; 43.1 | — |
| SECONDARY Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 |
2.7; NA; NA; 3.1; NA; NA | 0.016 sig |
| SECONDARY Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 |
41.2; NA; NA; 35.4; NA; NA | 0.008 sig |
| SECONDARY Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 |
40.2; NA; NA; 40.3; NA; NA | 0.002 sig |
| SECONDARY Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 |
18.6; NA; NA; 24.3; NA; NA | 0.048 sig |
| SECONDARY Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 |
2.7; NA; NA; 2.8; NA; NA | 0.001 sig |
| SECONDARY Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 |
4.1; NA; NA; 3.6; NA; NA | 1.000 |
| SECONDARY Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 |
4.4; NA; NA; 4.5; NA; NA | 0.017 sig |
| SECONDARY Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 |
2.5; NA; NA; 2.6; NA; NA | 0.002 sig |
| SECONDARY Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 |
-0.9; NA; NA; -0.3; NA; NA | 0.047 sig |
| SECONDARY Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 |
39.9; NA; NA; 39.7; NA; NA | 0.012 sig |
| SECONDARY Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 |
70.7; NA; NA; 71.9; NA; NA | 0.599 |
| SECONDARY Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 |
74.6; NA; NA; 73.7; NA; NA | 0.026 sig |
| SECONDARY Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 |
24.5; NA; NA; 24.2; NA; NA | 0.010 sig |
| SECONDARY Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 |
92.0; NA; NA; 91.8; NA; NA | 0.048 sig |
| SECONDARY Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 |
4.0; NA; NA; 4.0; NA; NA | 0.208 |
Eligibility Criteria
Inclusion Criteria
- Advanced idiopathic Parkinson's disease
Exclusion Criteria
- Other diseases which might influence compliance or participation in the study
Data sourced from ClinicalTrials.gov (NCT00141518). 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.