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Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00335153
Recruitment Status : Completed
First Posted : June 9, 2006
Results First Posted : January 16, 2015
Last Update Posted : January 16, 2015
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Advanced Parkinson's Disease
Interventions: Drug: Levodopa-carbidopa intestinal gel
Device: CADD-Legacy® 1400 ambulatory infusion pump
Device: PEG tube
Device: J-tube

  Participant Flow

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
Levodopa-Carbidopa Intestinal Gel (LCIG)

All participants were to receive levodopa-carbidopa intestinal gel (LCIG), via the nasojejunal (NJ) tube during the NJ Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.


Participant Flow for 2 periods

Period 1:   Nasojejunal (NJ) Test Period
    Levodopa-Carbidopa Intestinal Gel (LCIG)
STARTED   354 
COMPLETED   324 
NOT COMPLETED   30 
Adverse Event                5 
Lack of Efficacy                5 
Withdrawal by Subject                12 
Administrative                1 
Protocol Violation                7 

Period 2:   Post-PEG-J Long-Term Treatment Period
    Levodopa-Carbidopa Intestinal Gel (LCIG)
STARTED   324 
COMPLETED   272 
NOT COMPLETED   52 
Adverse Event                22 
Lack of Efficacy                2 
Withdrawal by Subject                13 
Administrative                13 
Protocol Violation                2 



  Baseline Characteristics

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
Levodopa-Carbidopa Intestinal Gel (LCIG)

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.


Baseline Measures
   Levodopa-Carbidopa Intestinal Gel (LCIG) 
Overall Participants Analyzed 
[Units: Participants]
 354 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.1  (9.1) 
Age, Customized 
[Units: Participants]
 
<65 years   171 
>=65 years   183 
Gender 
[Units: Participants]
 
Female   152 
Male   202 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs   [ Time Frame: Screening through Day 378 + 30 days ]

2.  Primary:   Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period   [ Time Frame: NJ Test Period (from 2 to 14 days) ]

3.  Primary:   Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy – With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods   [ Time Frame: PEG-J Surgery Period (from 2 to 14 days) through the Long Term Treatment Period (Day 28 to Day 378) ]

4.  Primary:   Number of Participants With Potentially Clinically Significant Values for Hematology Parameters   [ Time Frame: Screening through Day 378 ]

5.  Primary:   Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters   [ Time Frame: Screening through Day 378 ]

6.  Primary:   Number of Participants With Potentially Clinically Significant Vital Sign Parameters   [ Time Frame: up to 56 weeks ]

7.  Primary:   Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters   [ Time Frame: Screening through Day 378 ]

8.  Primary:   Number of Participants With Sleep Attacks at Baseline   [ Time Frame: Baseline ]

9.  Primary:   Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period   [ Time Frame: During the Post-PEG Long-Term Treatment Period (Day 28 through Day 378) ]

10.  Primary:   Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period   [ Time Frame: Baseline, during the Post-PEG Long-term Treatment Period (Day 28 through Day 378) ]

11.  Primary:   Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint   [ Time Frame: Baseline, Endpoint (last Post-PEG Long-Term Period visit up to Day 378) ]

12.  Primary:   Number of Participants With Confirmed Cases of Melanoma   [ Time Frame: Screening up to Day 378 ]

13.  Primary:   Number of Participants Taking at Least 1 Concomitant Medication During the Study   [ Time Frame: Screening up to Day 378 ]

14.  Secondary:   Change From Baseline in Average Daily "Off" Time at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

15.  Secondary:   Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

16.  Secondary:   Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

17.  Secondary:   Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

18.  Secondary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Month 12   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

19.  Secondary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

20.  Secondary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

21.  Secondary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

22.  Secondary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

23.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

24.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

25.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

26.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

27.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

28.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

29.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

30.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

31.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

32.  Secondary:   Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

33.  Secondary:   Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]

34.  Secondary:   Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint   [ Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00335153     History of Changes
Other Study ID Numbers: S187.3.004
2006-005186-18 ( EudraCT Number )
First Submitted: June 8, 2006
First Posted: June 9, 2006
Results First Submitted: January 12, 2015
Results First Posted: January 16, 2015
Last Update Posted: January 16, 2015