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Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease (ADEQUA)

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ClinicalTrials.gov Identifier: NCT02289729
Recruitment Status : Completed
First Posted : November 13, 2014
Results First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
Patient reported outcomes (PRO) have become an important endpoint assessed in clinical trials. It is important to understand the relationship between medication and patients' symptomatology, quality of life and well-being. We predict levodopa/carbidopa intestinal gel (LCIG; Duodopa) will significantly improve quality of life and emotional well-being compared to baseline in patients with advance Parkinson disease (APD) not well controlled with conventional treatment.

Condition or disease
Parkinson's Disease

Layout table for study information
Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease
Study Start Date : October 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Group/Cohort
All Participants
Levodopa/carbidopa intestinal gel (LCIG) prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.



Primary Outcome Measures :
  1. Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Global Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The PDQ-39 contains 39 items: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (score 0 to 4 on a Likert scale). The global score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

  2. Change From Baseline in PDQ-39 Mobility Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The mobility domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

  3. Change From Baseline in PDQ-39 Activities of Daily Living Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The activities of daily living domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

  4. Change From Baseline in PDQ-39 Emotional Well-Being Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The emotional well-being domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

  5. Change From Baseline in PDQ-39 Stigma Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The stigma domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

  6. Change From Baseline in PDQ-39 Social Support Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The social support domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

  7. Change From Baseline in PDQ-39 Cognition Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The cognition domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

  8. Change From Baseline in PDQ-39 Communication Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The communication domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

  9. Change From Baseline in PDQ-39 Bodily Discomfort Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The bodily discomfort domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.


Secondary Outcome Measures :
  1. Change From Baseline in Unified Parkinson's Disease Rating Scale Part III (UPDRS-III): Motor Examination at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS-III was used in ON state. The motor examination contains 27 items. Each item is scored in a Likert scale from 0 to 4. The UPDRS-III score was calculated summing the score of each item, ranging from 0 to 108, with higher score indicating more impairment.

  2. Change From Baseline in the Non-Motor Symptom Scale (NMSS) Global Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The global score was calculated summing the score of each item (severity x frequency), ranging from 0 to 360, with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

  3. Change From Baseline in NMSS Cardiovascular Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The cardiovascular domain score ranges from 0 to 24 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

  4. Change From Baseline in NMSS Sleep/Fatigue Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The sleep/fatigue domain score ranges from 0 to 48 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

  5. Change From Baseline in NMSS Mood/Cognition Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The mood/cognition domain score ranges from 0 to 72 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

  6. Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The perceptual problems/hallucinations domain score ranges from 0 to 36 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

  7. Change From Baseline in NMSS Attention/Memory Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The attention/memory domain score ranges from 0 to 36 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

  8. Change From Baseline in NMSS Gastrointestinal Tract Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The gastrointestinal tract domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms.

  9. Change From Baseline in NMSS Urinary Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The urinary domain score ranges from 0 to 36 with a lower score indicating fewer symptoms.A negative change from baseline indicates improvement in symptoms.

  10. Change From Baseline in NMSS Sexual Function Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The sexual function domain score ranges from 0 to 24 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

  11. Change From Baseline in NMSS Miscellaneous Domain Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The miscellaneous domain score ranges from 0 to 48 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

  12. Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Mean Global Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The Norris/Bond-Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.

  13. Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Alertness/Sedation Sub-Scale Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The Norris/Bond-Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.

  14. Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Contented/Discontented Sub-Scale Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The Norris/Bond-Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.

  15. Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Calmness/Relaxation Sub-Scale Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The Norris/Bond-Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.

  16. Change From Baseline in Parkinson Fatigue Scale (PFS-16) at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The PFS-16 comprises 16 items with five polytomous response categories (strongly disagree, disagree, do not agree or disagree, agree, and strongly agree). Responses were scored from 0 (strongly disagree) to 4 (strongly agree), yielding a summed total score ranging from 0 (no fatigue) to 64 (most severe fatigue). The cut-point of ≥ 3.30 was used to identified those perceiving fatigue to be a problem.

  17. Change From Baseline in the Score of the Apathy Scale (AS) to Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The AS is an inventory of 14 questions that assess cognitive and behavioral symptoms of emotional apathy. Each is rated from 0 to 3 on a Likert scale. The total scores for AS ranges from 0 (no apathy) to 42 (most apathetic). AS scores ≥ 14 were considered apathetic.

  18. Change From Baseline in Beck Depression Inventory, Second Edition (BDI-II) at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The BDI-II is a 21-item self-report multiple-choice inventory. Items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Raw scores from 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and 29-63 indicates severe depression.

  19. Change From Baseline in Beck Anxiety Inventory (BAI) at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The BAI is a 21-item self-report multiple-choice inventory. Items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Raw scores from 0-7 indicates minimal anxiety, 8-15 indicates mild anxiety, 16-25 indicates moderate anxiety, and 25-63 indicates severe anxiety.

  20. Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Composite Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 5-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total composite score ranging between 0 and 68, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

  21. Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Undesirable Side Effects at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total undesirable side effects score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

  22. Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Treatment Effectiveness at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total treatment effectiveness score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

  23. Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Convenience of Use at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total convenience of use score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

  24. Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Impact on Daily Living Activities at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total impact on daily living activities score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

  25. Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Medical Care at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total medical care score ranging between 0 and 8, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

  26. Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Global Satisfaction at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total global satisfaction score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

  27. Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Composite Score at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Composite scores range from 0 to 149, with higher scores indicating higher quality of life.

  28. Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Professional Activities at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Professional activities scores range from 0 to 38, with higher scores indicating higher quality of life.

  29. Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Social and Leisure Activities at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Social and leisure activities scores range from 0 to 58, with higher scores indicating higher quality of life.

  30. Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Caregiving Responsibilities at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Caregiving responsibilities scores range from 0 to 53, with higher scores indicating higher quality of life.

  31. Change From Baseline in Zarit Burden Interview (ZBI) at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The ZBI is a 22-item questionnaire in which caregivers must evaluate the level of agreement on a 5-point Likert scale from 0 to 4. The total score is obtained by the sum of the scores of the items. This total score represents a level of caregiver burden, with a range of 0 indicating no burden to 88 indicating completely overloaded.

  32. Change From Baseline in the Caregiver Stress Index (CSI) at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The CSI is a 13-item questionnaire based on identified common stressors. Answers are in yes/no format. Scoring is 1 point for each "yes" and 0 for each "no". The total score is obtained by the sum of the scores of the items. Minimum score is 0 (no stress) and maximum score is 13 (most stress). A score ≥ 7 indicates a high level of stress.

  33. Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Depression Sub-Scale for Caregivers at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The GADS is an 18-item self-report symptom inventory made up of two sub-scales, one for the detection of anxiety and another one for the detection of depression. Both sub-scales are composed of 9 questions. Answers are in yes/no format. Scoring is 1 point for each "yes" and 0 for each "no", with a total sub-scale score of 0 (no anxiety/depression) to 9 (worst anxiety/depression). In the Spanish validation of GADS, the cutoff point to consider probable anxiety disorder is 4 and 2 for probable depression.

  34. Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Anxiety Sub-Scale for Caregivers at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    The GADS is an 18-item self-report symptom inventory made up of two sub-scales, one for the detection of anxiety and another one for the detection of depression. Both sub-scales are composed of 9 questions. Answers are in yes/no format. Scoring is 1 point for each "yes" and 0 for each "no", with a total sub-scale score of 0 (no anxiety/depression) to 9 (worst anxiety/depression). In the Spanish validation of GADS, the cutoff point to consider probable anxiety disorder is 4 and 2 for probable depression.

  35. Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) at Month 6 [ Time Frame: Baseline, Month 6 (±15 days) ]
    Absenteeism, presented as the mean percentage of work time missed due to caregiving (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to caregiving / (number of hours of work missed due to caregiving + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

  36. Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Caregiving (Presenteeism) [ Time Frame: Baseline, Month 6 (±15 days) ]
    Presenteeism (the extent to which caregiving decreased productivity) is presented as the mean percentage of impairment while working due to caregiving, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

  37. Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to Caregiving [ Time Frame: Baseline, Month 6 (±15 days) ]
    The mean percentage of OWPI due to caregiving (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which caregiving decreased productivity (%)* [number of hours worked / (number of hours of work missed due to caregiving + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

  38. Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Caregiving [ Time Frame: Baseline, Month 6 (±15 days) ]
    Activity impairment due to caregiving (the extent to which caregiving affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity/activity and 100% representing complete impact on productivity/activity.

  39. Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline [ Time Frame: Baseline ]

    Spearman correlation statistics were calculated for the quality of life of the participants (Global PDQ-39, see Outcome Measure 1) and the following scales: UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), NMSS (see Outcome Measure 11), BAI (see Outcome Measure 28), BDI-III (see Outcome Measure 27), AS (see Outcome Measure 26), PFS (see Outcome Measure 25), Norris Bond-Lader (NBL) Alertness-Sedation (A-S; see Outcome Measure 22), NBL Contented-Discontented (C-D; see Outcome Measure 23), NBL Calm-Relaxed (C-R; see Outcome Measure 24), ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42).

    The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for "yes" and 0 for "no." The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability.


  40. Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 [ Time Frame: Month 6 (±15 days) ]

    Spearman correlation statistics were calculated for the quality of life of the participants (Global PDQ-39, see Outcome Measure 1) and the following scales: UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), NMSS (see Outcome Measure 11), BAI (see Outcome Measure 28), BDI-III (see Outcome Measure 27), AS (see Outcome Measure 26), PFS (see Outcome Measure 25), Norris Bond-Lader (NBL) Alertness-Sedation (A-S; see Outcome Measure 22), NBL Contented-Discontented (C-D; see Outcome Measure 23), NBL Calm-Relaxed (C-R; see Outcome Measure 24), ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42).

    The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for "yes" and 0 for "no." The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability.


  41. Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline [ Time Frame: Baseline ]

    Spearman correlation statistics were calculated for the quality of life of the caregivers (Global SQLC, see Outcome Measure ) and the following scales: ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42), NBL A-S (see Outcome Measure 22), NBL C-D (see Outcome Measure 23), NBL C-R (see Outcome Measure 24), Global PDQ-39 (see Outcome Measure 1), UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), and Global NMSS (see Outcome Measure 11).

    The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for "yes" and 0 for "no." The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability.


  42. Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6 [ Time Frame: Month 6 (±15 days) ]

    Spearman correlation statistics were calculated for the quality of life of the caregivers (Global SQLC, see Outcome Measure ) and the following scales: ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42), NBL A-S (see Outcome Measure 22), NBL C-D (see Outcome Measure 23), NBL C-R (see Outcome Measure 24), Global PDQ-39 (see Outcome Measure 1), UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), and Global NMSS (see Outcome Measure 11).

    The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for "yes" and 0 for "no." The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Advanced Parkinson's Disease patients
Criteria

Inclusion Criteria:

  • Patients with advanced levodopa-responsive Parkinson's disease, with at least, 2 hours "off" time or 2 hours of dyskinesia based on clinician's/investigator's medical judgment
  • Patients with advanced Parkinson's disease with severe motor fluctuations and dyskinesia when combination of conventional PD treatments was unable to satisfactory control symptoms.
  • Patients with advanced Parkinson's disease who meet the criteria for use of Levodopa/Carbidopa Intestinal Gel (LCIG) established in the summary of product characteristics, Spanish Neurology Society (SEN) guidelines, local/regional directories (CCAA) or site's protocols for use of LCIG in common clinical practice.
  • The decision to treat with LCIG is made by the physician prior to any decision to approach the patient to participate in this study.
  • Patients with a cognitive level enough to complete the questionnaires, confirmed by a Mini-mental state examination (MMSE) score of at least 26 points, according to the recommendation of the Movement Disorder Society (MDS) task force on dementia in Parkinson's Disease (PD)

Exclusion Criteria:

  • LCIG's contraindications included in the Summary of Product Characteristics (product label)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289729


Sponsors and Collaborators
AbbVie
Investigators
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Principal Investigator: Francesc Valldeoriola, MD Hospital Clinic of Barcelona

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02289729     History of Changes
Other Study ID Numbers: P14-335
First Posted: November 13, 2014    Key Record Dates
Results First Posted: January 30, 2019
Last Update Posted: January 30, 2019
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AbbVie:
Duodopa
Advanced Parkinson's Disease
Levodopa/Carbidopa intestinal gel

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
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