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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
Results First Received: April 11, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Advanced Idiopathic Parkinson's Disease
Interventions: 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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Duodopa Naïve Duodopa-naïve participants were 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.
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.
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.

Participant Flow:   Overall Study
    Duodopa Naïve     Duodopa Non-naïve < 2 Years     Duodopa Non-naïve ≥ 2 Years  
STARTED     37     22     18  
Safety Sample     36     22     18  
Full Analysis Sample     27     22     18  
COMPLETED     21     16     12  
NOT COMPLETED     16     6     6  
Withdrew Consent Prior to Treatment                 1                 0                 0  
Adverse Event                 7                 5                 2  
Withdrawal by Subject                 2                 0                 2  
Protocol Violation                 1                 1                 2  
Lack of Efficacy                 5                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Duodopa Naïve Duodopa-naïve participants were 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.
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.
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.
Total Total of all reporting groups

Baseline Measures
    Duodopa Naïve     Duodopa Non-naïve < 2 Years     Duodopa Non-naïve ≥ 2 Years     Total  
Number of Participants  
[units: participants]
  27     22     18     67  
Age  
[units: years]
Mean (Standard Deviation)
  64.6  (6.4)     65.4  (5.2)     66.6  (8.7)     65.4  (6.8)  
Gender  
[units: participants]
       
Female     11     7     6     24  
Male     16     15     12     43  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12   [ Time Frame: Baseline (Month -3), Month 12 ]

4.  Primary:   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 ]

5.  Primary:   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 ]

6.  Primary:   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 ]

7.  Primary:   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 ]

8.  Primary:   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 ]

9.  Secondary:   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) ]

10.  Secondary:   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) ]

11.  Secondary:   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) ]

12.  Secondary:   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) ]

13.  Secondary:   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) ]

14.  Secondary:   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) ]

15.  Secondary:   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) ]

16.  Secondary:   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) ]

17.  Secondary:   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) ]

18.  Secondary:   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) ]

19.  Secondary:   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) ]

20.  Secondary:   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) ]

21.  Secondary:   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) ]

22.  Secondary:   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) ]

23.  Secondary:   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) ]

24.  Secondary:   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) ]

25.  Secondary:   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) ]

26.  Secondary:   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) ]

27.  Secondary:   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) ]

28.  Secondary:   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) ]

29.  Secondary:   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) ]

30.  Secondary:   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) ]

31.  Secondary:   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) ]

32.  Secondary:   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) ]

33.  Secondary:   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) ]

34.  Secondary:   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) ]

35.  Secondary:   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) ]

36.  Secondary:   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) ]

37.  Secondary:   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) ]

38.  Secondary:   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) ]

39.  Secondary:   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) ]

40.  Secondary:   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) ]

41.  Secondary:   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) ]

42.  Secondary:   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) ]

43.  Secondary:   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) ]

44.  Secondary:   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) ]

45.  Secondary:   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) ]

46.  Secondary:   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) ]

47.  Secondary:   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) ]

48.  Secondary:   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) ]

49.  Secondary:   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) ]

50.  Secondary:   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) ]

51.  Secondary:   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) ]

52.  Secondary:   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) ]

53.  Secondary:   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) ]

54.  Other Pre-specified:   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) ]

55.  Other Pre-specified:   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) ]

56.  Other Pre-specified:   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) ]

57.  Other Pre-specified:   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) ]

58.  Other Pre-specified:   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) ]

59.  Other Pre-specified:   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) ]

60.  Other Pre-specified:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110



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