Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact (DAPHNE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00141518
First received: August 30, 2005
Last updated: June 6, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Advanced Idiopathic Parkinson's Disease
Drug: Levodopa-carbidopa intestinal gel (LCIG)
Device: CADD-Legacy® 1400 ambulatory infusion pump
Device: percutaneous endoscopic gastrostomy tube (PEG tube)
Device: jejunal extension tube (J-tube)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 [ Time Frame: Baseline (Month -3), Month 12 ] [ Designated as safety issue: No ]
    The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect); for Part IV, questions are measured on a 5- or 2-point scale (0 or 1). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.

  • Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12 [ Time Frame: Baseline (Month -3), Month 12 ] [ Designated as safety issue: No ]
    The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state).

  • EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12 [ Time Frame: Baseline (Month -3), Month 12 ] [ Designated as safety issue: No ]
    The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state.

  • Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010 [ Time Frame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants ] [ Designated as safety issue: No ]

    Total monthly costs include

    • Direct medical costs (inpatient care, outpatient care, and drug costs [including Duodopa cost and cost of concomitant anti-PD medication]).
    • Direct non-medical costs (nursing home, home help, personal assistance, informal care [from family member or friend] and transportation to inpatient, outpatient visits and nursing home).
    • Indirect costs (sick-leave and early retirement due to PD [applied to individuals only up to the age of 65 since the main indirect cost item, early retirement due to disability, is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden]).

    The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.


  • Monthly Drug Costs Per Participant, SEK 2010 [ Time Frame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants ] [ Designated as safety issue: No ]
    Drug costs include Duodopa cost and cost of concomitant anti-PD medication. Drug costs are a direct medical cost. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.

  • Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010 [ Time Frame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants ] [ Designated as safety issue: No ]
    Direct medical costs consist of inpatient care, outpatient care (visits to physician, nurse, physiotherapist, occupational therapist, dietitian, speech therapist, counselor, and phone consultations). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.

  • Direct Monthly Non-medical Costs Per Participant, SEK 2010 [ Time Frame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants ] [ Designated as safety issue: No ]
    Direct non-medical costs include nursing home, home help, personal assistance, informal care (from family member or friend) and transportation to inpatient, outpatient visits and nursing home. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.

  • Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 [ Time Frame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until Month 36 ] [ Designated as safety issue: No ]
    Indirect costs consist of sick-leave and early retirement due to PD, are applied to individuals only up to the age of 65 since the main indirect cost item - early retirement due to disability - is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.


Secondary Outcome Measures:
  • Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The current stage of PD was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.

  • Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The best PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.

  • Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The worst PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.

  • Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Schwab and England scale was used to rate the subject's best "on" period during the past week by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%). "On" time is when PD symptoms are well controlled by the drug.

  • Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint visit (Month 36 or last visit if discontinued early) ] [ Designated as safety issue: No ]
    The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function.

  • MMSE Orientation Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The orientation subscale has a total possible score of 0 to 10, with higher scores indicating better function.

  • MMSE Registration Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Registration subscale a total possible score of 0 to 3, with higher scores indicating better function.

  • MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Attention and Calculation subscale results in a total possible score of 0 to 5, with higher scores indicating better function.

  • MMSE Recall Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Recall subscale results in a total possible score of 0 to 3, with higher scores indicating better function.

  • MMSE Language Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Language subscale results in a total possible score of 0 to 9, with higher scores indicating better function.

  • Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).

  • MADRS Reported Sadness Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reported Sadness scores rate depressed mood, regardless of whether it is reflected in appearance or not, and includes low spirits, despondency or the feeling of being beyond help and without hope.

  • MADRS Apparent Sadness Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Apparent sadness scores rate despondency, gloom and despair (more than just ordinary transient low spirits), reflected in speech, facial expression, and posture.

  • MADRS Inner Tension Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inner Tension scores rate feelings of ill-defined discomfort, edginess, inner turmoil, mental tension mounting to either panic, dread or anguish.

  • MADRS Reduced Sleep Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Sleep scores rate the experience of reduced duration or depth of sleep compared to the participant's own normal pattern when well.

  • MADRS Reduced Appetite Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Appetite scores rate the feeling of a loss of appetite compared with when-well. Rate by loss of desire for food or the need to force oneself to eat.

  • MADRS Concentration Difficulties Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Concentration Difficulties scores rate difficulties in collecting one's thoughts mounting to an incapacitating lack of concentration.

  • MADRS Lassitude Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Lassitude scores rate difficulty in getting started or slowness in initiating and performing everyday activities.

  • MADRS Inability to Feel Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inability to Feel scores rate the subjective experience of reduced interest in the surroundings, or activities that normally give pleasure. The ability to react with adequate emotion to circumstances or people is reduced.

  • MADRS Pessimistic Thoughts Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Pessimistic Thoughts scores rate thoughts of guilt, inferiority, self-reproach, sinfulness, remorse and ruin.

  • MADRS Suicidal Thoughts Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Suicidal Thoughts scores rate the feeling that life is not worth living, that a natural death would be welcome, suicidal thoughts, and preparations for suicide.

  • Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible, which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.

  • PDQ-39 Mobility Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

  • PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

  • PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

  • PDQ-39 Stigma Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

  • PDQ-39 Social Support Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

  • PDQ-39 Cognition Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

  • PDQ-39 Communication Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

  • PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

  • Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Walking scores ranged from 1 (worst) to 5 (best).

  • Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. "Off" time is when PD symptoms are not adequately controlled by the drug, and is represented as a percentage of total time awake per day.

  • Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. "On" time is when PD symptoms are well controlled by the drug, and is represented as a percentage of total time of the last __ hours.

  • Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Dyskinetic time' is time with involuntary muscle movement, and is represented as a percentage of total time of the last __ hours.

  • Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Off time' is when PD symptoms are not adequately controlled by the drug. Magnitude scores were 1 (worst) to 5 (best).

  • Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Dyskinetic time' is time with involuntary muscle movement. Magnitude scores were 1 (worst) to 5 (best).

  • Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Cramps' scores were 1 (worst) to 5 (best).

  • Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Satisfied with function' scores were 1 (worst) to 5 (best).

  • Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Self-assessment' scores were -3 (Off) to +3 (dyskinetic). 'Off' time is when PD symptoms are not adequately controlled by the drug. 'Dyskinetic' time is time with involuntary muscle movement. "0" is defined as the normal ON state without dyskinesia (the desired motor state). Everything closer to "0" means improvement, everything more away from "0" means either less mobility (in the negative score) or involuntary movements (dyskinesia, in the positive score).

  • Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Free tapping is defined as voluntary repetitive finger tapping on computer-generated fields. 'Free tapping speed' is a count of the number of taps per 20 seconds.

  • Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Free tapping' is defined as ____. 'Free tapping accuracy' is the percentage of accurate free taps per 20 seconds(?).

  • Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Tapping at increased speed - accuracy' is the percentage of accurate taps per all taps on computer-generated fields.

  • Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed' is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds.

  • Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed' is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds. 'Tapping random chase - accuracy' is the percentage of accurate random chase taps.

  • Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 [ Time Frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Drawing impairment was assessed as a spiral score, where the participant is asked to draw a spiral. 1 is worst score, 10 is best.


Other Outcome Measures:
  • UPDRS Total Score up to Month 36 [ Time Frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.

  • UPDRS Part I Score, up to Month 36 [ Time Frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Higher scores are associated with more disability.

  • UPDRS Part II Score, up to Month 36 [ Time Frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Higher scores are associated with more disability.

  • UPDRS Part III Score, up to Month 36 [ Time Frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Higher scores are associated with more disability.

  • UPDRS Part IV Score, up to Month 36 [ Time Frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Part IV, questions are measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect) or 2-point scale (0 or 1). Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Higher scores are associated with more disability.

  • EQ-5D Descriptive Systems Summary Index Score, up to Month 36 [ Time Frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.

  • EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 [ Time Frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) ] [ Designated as safety issue: No ]
    The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'


Enrollment: 77
Study Start Date: March 2006
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duodopa Naïve
Duodopa-naïve participants titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
Drug: Levodopa-carbidopa intestinal gel (LCIG)
Other Names:
  • DUOPA™ (carbidopa and levodopa Enteral Suspension)
  • DUODOPA®
  • ABT-SLV187
Device: CADD-Legacy® 1400 ambulatory infusion pump Device: percutaneous endoscopic gastrostomy tube (PEG tube) Device: jejunal extension tube (J-tube)
Experimental: Duodopa Non-naïve < 2 Years
Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
Drug: Levodopa-carbidopa intestinal gel (LCIG)
Other Names:
  • DUOPA™ (carbidopa and levodopa Enteral Suspension)
  • DUODOPA®
  • ABT-SLV187
Device: CADD-Legacy® 1400 ambulatory infusion pump Device: percutaneous endoscopic gastrostomy tube (PEG tube) Device: jejunal extension tube (J-tube)
Experimental: Duodopa Non-naïve ≥ 2 years
Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
Drug: Levodopa-carbidopa intestinal gel (LCIG)
Other Names:
  • DUOPA™ (carbidopa and levodopa Enteral Suspension)
  • DUODOPA®
  • ABT-SLV187
Device: CADD-Legacy® 1400 ambulatory infusion pump Device: percutaneous endoscopic gastrostomy tube (PEG tube) Device: jejunal extension tube (J-tube)

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Advanced idiopathic Parkinson's disease

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141518

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Lars Bergmann, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00141518     History of Changes
Other Study ID Numbers: S187.4.001  2005-002654-21 
Study First Received: August 30, 2005
Results First Received: April 11, 2016
Last Updated: June 6, 2016
Health Authority: Sweden: Medical Products Agency

Keywords provided by AbbVie:
Health economics,Quality of life

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists

ClinicalTrials.gov processed this record on July 28, 2016