Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00660387
First received: April 15, 2008
Last updated: January 12, 2015
Last verified: January 2015
Results First Received: January 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Advanced Parkinson's Disease
Interventions: Drug: Levodopa carbidopa intestinal gel (LCIG)
Drug: Placebo Gel
Drug: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets
Drug: Placebo (PBO) oral capsules
Device: CADD-Legacy® 1400 ambulatory infusion pump
Device: PEG tube
Device: J-tube

  Participant Flow
  Hide 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
Studies S187.3.001 (NCT00357994) and S187.3.002 (NCT00660387) were 2 identically designed, Phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting subjects from distinct sites. All study information and results presented reflect the study data and analyses for the two studies combined.

Reporting Groups
  Description
LCIG + Placebo Capsules Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Placebo Gel + Levodopa-Carbidopa Capsules Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.

Participant Flow:   Overall Study
    LCIG + Placebo Capsules     Placebo Gel + Levodopa-Carbidopa Capsules  
STARTED     37     34  
COMPLETED     35     31  
NOT COMPLETED     2     3  
Adverse Event                 1                 2  
Lack of Efficacy                 0                 1  
Protocol Violation                 1                 0  



  Baseline Characteristics
  Hide 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
LCIG + Placebo Capsules Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Placebo Gel + Levodopa-Carbidopa Capsules Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Total Total of all reporting groups

Baseline Measures
    LCIG + Placebo Capsules     Placebo Gel + Levodopa-Carbidopa Capsules     Total  
Number of Participants  
[units: participants]
  37     34     71  
Age  
[units: years]
Mean ± Standard Deviation
  63.7  ± 9.5     65.1  ± 6.8     64.4  ± 8.3  
Age, Customized  
[units: participants]
     
<65 years     21     15     36  
>=65 years     16     19     35  
Gender  
[units: participants]
     
Female     13     12     25  
Male     24     22     46  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Week 12 in Average Daily Normalized "Off" Time   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Change From Baseline in Average Daily Normalized "On" Time Without Troublesome Dyskinesia at Week 12   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12   [ Time Frame: Baseline, Week 12 ]

4.  Secondary:   Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12   [ Time Frame: Baseline, Week 12 ]

5.  Secondary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12   [ Time Frame: Baseline, Week 12 ]

6.  Secondary:   Change From Baseline in UPDRS Part III Score at Week 12   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:   Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12   [ Time Frame: Baseline, Week 12 ]

8.  Secondary:   Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12   [ Time Frame: Baseline, Week 12 ]

9.  Secondary:   Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Week 12   [ Time Frame: Baseline, Week 12 ]

10.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12   [ Time Frame: Baseline, Week 12 ]

11.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12   [ Time Frame: Baseline, Week 12 ]

12.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12   [ Time Frame: Baseline, Week 12 ]

13.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12   [ Time Frame: Baseline, Week 12 ]

14.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12   [ Time Frame: Baseline, Week 12 ]

15.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12   [ Time Frame: Baseline, Week 12 ]

16.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12   [ Time Frame: Baseline, Week 12 ]

17.  Secondary:   Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12   [ Time Frame: Baseline, Week 12 ]

18.  Secondary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 12   [ Time Frame: Baseline, Week 12 ]

19.  Secondary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12   [ Time Frame: Baseline, Week 12 ]

20.  Secondary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12   [ Time Frame: Baseline, Week 12 ]

21.  Secondary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12   [ Time Frame: Baseline, Week 12 ]

22.  Secondary:   Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12   [ Time Frame: Baseline, Week 12 ]

23.  Secondary:   Employment Impairment (EMP) I Status at Baseline   [ Time Frame: Baseline ]

24.  Secondary:   Employment Impairment (EMP) II Status at Week 12   [ Time Frame: Week 12 (or early termination) ]


  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
No text entered.


  More Information
  Hide 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


No publications provided by AbbVie

Publications automatically indexed to this study:

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00660387     History of Changes
Other Study ID Numbers: S187.3.002, 2007-003814-32
Study First Received: April 15, 2008
Results First Received: January 12, 2015
Last Updated: January 12, 2015
Health Authority: United States: Food and Drug Administration
New Zealand: Ministry of Health