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A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01736176
First received: November 27, 2012
Last updated: December 16, 2016
Last verified: December 2016
Results First Received: December 16, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Advanced Parkinson's Disease
Interventions: Drug: Levodopa-Carbidopa Intestinal Gel
Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J)
Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets

  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
This study was conducted at 12 sites in the United States that specialized in movement disorders. Participants were levodopa-responsive with advanced Parkinson's disease (PD) and persistent motor fluctuations despite attempts to optimize treatment with oral levodopa-carbidopa and other available anti-PD medications.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During screening participants converted their current daytime levodopa-carbidopa doses to oral levodopa-carbidopa 100/25 mg immediate release (LC-IR); other anti-PD medications could be continued, reduced or discontinued at the investigator's discretion. LC-IR and all other anti-PD treatments were discontinued at LCIG initiation.

Reporting Groups
  Description
Levodopa-Carbidopa Intestinal Gel (LCIG) Participants had a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually. The starting total daily dose of LCIG was based solely on the daily dose of the oral levodopa taken immediately prior to Day 1 and was adjusted to obtain the optimal clinical response for the individual participant. Participants received treatment for up to 60 weeks; participants who completed their Week 60 visit before LCIG was commercially available had the option to extend their LCIG therapy, if in the opinion of the investigator, the participant would benefit from continued LCIG treatment.

Participant Flow:   Overall Study
    Levodopa-Carbidopa Intestinal Gel (LCIG)
STARTED   39 [1] 
Received LCIG   38 
COMPLETED   28 
NOT COMPLETED   11 
Adverse Event                3 
Withdrawal by Subject                4 
Lack of Efficacy                3 
Unable to Complete PEG Placement                1 
[1] Enrolled participants who underwent the PEG-J placement procedure



  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
Levodopa-Carbidopa Intestinal Gel Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.

Baseline Measures
   Levodopa-Carbidopa Intestinal Gel 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 39 
   64.3  (10.23) 
Age, Customized 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 39 
< 65 years      17  43.6% 
≥ 65 years      22  56.4% 
Gender 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 39 
Female      16  41.0% 
Male      23  59.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 39 
White      36  92.3% 
Black or African American      1   2.6% 
Asian      2   5.1% 
American Indian or Alaska Native      0   0.0% 
Native Hawaiian or other Pacific Islander      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 39 
Hispanic or Latino      2   5.1% 
Not Hispanic or Latino      37  94.9% 
Duration of PD 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 39 
   11.5  (5.34) 
PD Symptoms Present 
[Units: Participants]
Count of Participants
 
Bradykinesia   
Participants Analyzed 
[Units: Participants]
 39 
Bradykinesia   37 
Muscular rigidity   
Participants Analyzed 
[Units: Participants]
 39 
Muscular rigidity   33 
Resting tremor   
Participants Analyzed 
[Units: Participants]
 39 
Resting tremor   25 
Postural instability   
Participants Analyzed 
[Units: Participants]
 39 
Postural instability   22 
Non-Motor Symptoms Scale (NMSS) Total Score [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 38 
   48.3  (35.63) 
[1] The NMSS assesses non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous. Severity is rated on a scale from 0 (none) to 3 (severe). Frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The NMSS total score ranges from 0 to 360 with a lower score more desirable than a higher score. Baseline was the last measurement before the first dose of oral study drug.
[2] Data are reported for the efficacy dataset which includes all participants who received at least 1 infusion of LCIG study drug and had a baseline and LCIG Treatment Period observation for at least one efficacy or health outcome measure.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Week 12 in the Non-Motor Symptom Scale (NMSS) Total Score   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Number of Participants Who Used Healthcare Resources During the First 4 Weeks   [ Time Frame: Weeks 1-4 ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: Weeks 1-4 and Overall (from Week 1 through 30 days after the end of the LCIG Treatment Period; median duration of LCIG device exposure was 428 days) ]

4.  Secondary:   Number of Participants Who Used Healthcare Resources Through Week 60   [ Time Frame: Week 60 ]

5.  Secondary:   Change From Baseline to Week 60 in the Non-Motor Symptom Scale (NMSS) Total Score   [ Time Frame: Baseline and Week 60 ]

6.  Secondary:   Change From Baseline in NMSS Cardiovascular Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

7.  Secondary:   Change From Baseline in NMSS Sleep/Fatigue Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

8.  Secondary:   Change From Baseline in NMSS Mood/Cognition Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

9.  Secondary:   Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

10.  Secondary:   Change From Baseline in NMSS Attention/Memory Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

11.  Secondary:   Change From Baseline in NMSS Gastrointestinal Tract Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

12.  Secondary:   Change From Baseline in NMSS Urinary Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

13.  Secondary:   Change From Baseline in NMSS Sexual Function Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

14.  Secondary:   Change From Baseline in NMSS Miscellaneous Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

15.  Secondary:   Change From Baseline in Mean Daily Normalized "Off" Time Based on Parkinson's Disease Diary   [ Time Frame: Baseline and Week 12 and Week 60 ]

16.  Secondary:   Change From Baseline in Mean Daily Normalized "On" Time Without Troublesome Dyskinesia Based on PD Diary   [ Time Frame: Baseline and Week 12 and Week 60 ]

17.  Secondary:   Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

18.  Secondary:   Change From Baseline in UPDRS Part I: Mentation, Behavior, and Mood Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

19.  Secondary:   Change From Baseline in UPDRS Part II: Activities of Daily Living (ADL) Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

20.  Secondary:   Change From Baseline in UPDRS Part III: Motor Examination Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

21.  Secondary:   Change From Baseline in UPDRS Part IV: Complications of Therapy Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

22.  Secondary:   Change From Baseline in UPDRS Dyskinesia Items Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

23.  Secondary:   Change From Baseline in UPDRS Part V: Modified Hoehn and Yahr Staging Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

24.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Summary Index   [ Time Frame: Baseline and Week 12 and Week 60 ]

25.  Secondary:   Change From Baseline in PDQ-39 Mobility Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

26.  Secondary:   Change From Baseline in PDQ-39 Activities of Daily Living Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

27.  Secondary:   Change From Baseline in PDQ-39 Emotional Well-Being Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

28.  Secondary:   Change From Baseline in PDQ-39 Stigma Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

29.  Secondary:   Change From Baseline in PDQ-39 Social Support Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

30.  Secondary:   Change From Baseline in PDQ-39 Cognition Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

31.  Secondary:   Change From Baseline in PDQ-39 Communication Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

32.  Secondary:   Change From Baseline in PDQ-39 Bodily Discomfort Domain Score   [ Time Frame: Baseline and Week 12 and Week 60 ]

33.  Secondary:   Percentage of Participants With a Patient Global Impression of Change (PGIC) Response of Improved   [ Time Frame: Week 12 and Week 60 ]

34.  Secondary:   Treatment Satisfaction Questionnaire Scores   [ Time Frame: Week 12 and Week 60 ]

35.  Secondary:   Change From Baseline in Health-related Productivity   [ Time Frame: Baseline, Week 12 and Week 60 ]

36.  Secondary:   Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory Between Errors Score at Week 12   [ Time Frame: Baseline and Week 12 ]

37.  Secondary:   Change From Baseline in CANTAB Spatial Working Memory Strategy Score at Week 12   [ Time Frame: Baseline and Week 12 ]

38.  Secondary:   Change From Baseline in Controlled Oral Word Association Test (COWAT) Verbal Fluency Scores at Week 60   [ Time Frame: Baseline and Week 60 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01736176     History of Changes
Other Study ID Numbers: M12-920
Study First Received: November 27, 2012
Results First Received: December 16, 2016
Last Updated: December 16, 2016