Clinical trial NCT00141518: Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact
Official title: A Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/Dyskinesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Advanced Idiopathic Parkinson's Disease
Keywords: Health economics,Quality of life
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

- Advanced idiopathic Parkinson's disease

Exclusion Criteria:

- Other diseases which might influence compliance or participation in the study

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12
timeFrame: Baseline (Month -3), Month 12
measure: Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12
timeFrame: Baseline (Month -3), Month 12
measure: EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12
timeFrame: Baseline (Month -3), Month 12
measure: Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010
timeFrame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants
measure: Monthly Drug Costs Per Participant, SEK 2010
timeFrame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants
measure: Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010
timeFrame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants
measure: Direct Monthly Non-medical Costs Per Participant, SEK 2010
timeFrame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants
measure: Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010
timeFrame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until Month 36
Secondary outcomes:
measure: Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint visit (Month 36 or last visit if discontinued early)
measure: MMSE Orientation Subscale Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MMSE Registration Subscale Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MMSE Attention and Calculation Subscale Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MMSE Recall Subscale Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MMSE Language Subscale Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MADRS Reported Sadness Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MADRS Apparent Sadness Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MADRS Inner Tension Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MADRS Reduced Sleep Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MADRS Reduced Appetite Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MADRS Concentration Difficulties Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MADRS Lassitude Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MADRS Inability to Feel Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MADRS Pessimistic Thoughts Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: MADRS Suicidal Thoughts Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: PDQ-39 Mobility Subscale Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: PDQ-39 Stigma Subscale Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: PDQ-39 Social Support Subscale Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: PDQ-39 Cognition Subscale Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: PDQ-39 Communication Subscale Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36
timeFrame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Other outcomes:
measure: UPDRS Total Score up to Month 36
timeFrame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: UPDRS Part I Score, up to Month 36
timeFrame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: UPDRS Part II Score, up to Month 36
timeFrame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: UPDRS Part III Score, up to Month 36
timeFrame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: UPDRS Part IV Score, up to Month 36
timeFrame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: EQ-5D Descriptive Systems Summary Index Score, up to Month 36
timeFrame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
measure: EQ-5D Visual Analog Scale (VAS) Score, up to Month 36
timeFrame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Locations:
Study officials:
affiliation: AbbVie
name: Lars Bergmann, MD
role: STUDY_DIRECTOR
References: