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A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease (APEX-PD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00880620
First received: April 3, 2009
Last updated: January 25, 2016
Last verified: January 2016
Results First Received: December 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Drug: placebo
Drug: IPX066

  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
First patient enrolled: 4/13/2009 Last patient out 10/05/2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following enrollment, subjects were randomized into one of the four treatment groups.

Reporting Groups
  Description
Placebo Placebo capsules were used
IPX066 Dose Level 1 IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
IPX066 Dose Level 2 IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
IPX066 Dose Level 3 IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa

Participant Flow:   Overall Study
    Placebo   IPX066 Dose Level 1   IPX066 Dose Level 2   IPX066 Dose Level 3
STARTED   92   87   104   98 
COMPLETED   71   72   83   74 
NOT COMPLETED   21   15   21   24 
Adverse Event                4                5                15                15 
Death                0                0                1                0 
Lack of Efficacy                12                4                0                1 
Lost to Follow-up                0                1                1                0 
Protocol Violation                0                1                0                2 
Withdrawal by Subject                4                3                1                3 
Noncompliance                0                0                1                1 
Not specified                1                1                2                2 



  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.
Baseline Analysis Population is all treated

Reporting Groups
  Description
Placebo Placebo capsules were used
IPX066 Dose Level 1 IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
IPX066 Dose Level 2 IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
IPX066 Dose Level 3 IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
Total Total of all reporting groups

Baseline Measures
   Placebo   IPX066 Dose Level 1   IPX066 Dose Level 2   IPX066 Dose Level 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 92   87   104   98   381 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.4  (9.43)   63.8  (9.81)   65.2  (9.73)   64.8  (9.32)   64.8  (9.55) 
Gender 
[Units: Participants]
         
Female   40   40   45   44   169 
Male   52   47   59   54   212 
Ethnicity (NIH/OMB) 
[Units: Participants]
         
Hispanic or Latino   3   5   7   4   19 
Not Hispanic or Latino   87   78   91   89   345 
Unknown or Not Reported   2   4   6   5   17 
Race/Ethnicity, Customized 
[Units: Participants]
         
Asian   1   0   0   1   2 
Black or African American   0   0   2   0   2 
White   90   87   102   96   375 
Other   1   0   0   1   2 
Region of Enrollment 
[Units: Participants]
         
Canada   10   9   9   9   37 
Latvia   1   1   0   0   2 
Romania   13   13   15   14   55 
United States   30   29   37   38   134 
Ukraine   28   29   32   26   115 
Lithuania   7   4   8   8   27 
Estonia   3   2   3   3   11 
Age at Parkinson's disease onset 
[Units: Years]
Mean (Standard Deviation)
 63.7  (9.48)   61.7  (10.71)   63.6  (10.43)   63.0  (9.38)   63.0  (10.00) 
Duration of Parkinson's disease 
[Units: Years]
Mean (Standard Deviation)
 1.8  (2.01)   2.3  (3.08)   1.8  (1.85)   2.0  (2.33)   2.0  (2.34) 
UPDRS Parts II and III Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 36.3  (11.89)   36.1  (13.56)   38.1  (15.63)   36.3  (13.04)   36.7  (13.63) 
[1]

Unified Parkinson’s Disease Rating Scale (UPDRS) – Four Parts Higher score values represent a worse outcome.

Subscales II and III were summed:

Part I: Mentation, Behavior and Mood – 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living – 13 questions 5-17 Score range: 0-52 Part III: Motor Examination – 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) – 11 questions Score range: 0-25

Hoehn and Yahr Stage [1] 
[Units: Units on a scale]
         
Stage I   7   6   13   14   40 
Stage II   69   62   65   62   258 
Remaining   16   19   26   22   83 
[1]

Hoehn and Yahr Staging of Parkinson’s Disease: Stages move from 1 – 5 with the worse outcome stage being Stage 5.

Stage 1 = Symptoms on one side of the body only. Stage 2 = Symptoms on both sides of the body, No impairment of balance. Stage 3 = Balance impairment. Mild to moderate disease. Physically independent. Stage 4 = Severe disability but still able to walk or stand unassisted. Stage 5 = Wheelchair bound or bedridden unless assisted.

MMSE [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 28.9  (1.18)   29.0  (1.27)   28.7  (1.21)   28.9  (1.18)   28.9  (1.21) 
[1] The Mini–Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10–18 points) or mild (19–23 points) cognitive impairment.


  Outcome Measures

1.  Primary:   Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30   [ Time Frame: Week 30 ]

2.  Secondary:   Parkinson's Disease Questionnaire-39 (PDQ-39)   [ Time Frame: Week 30 ]
Results not yet reported.   Anticipated Reporting Date:   02/2016   Safety Issue:   No

3.  Secondary:   Safety   [ Time Frame: Week 30 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
No text entered.


  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: Daven Mody, PharmD, MBA, Director of Regulatory Affairs
Organization: Impax Laboratories, Inc.
phone: 510-240-6073
e-mail: dmody@impaxlabs.com



Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00880620     History of Changes
Other Study ID Numbers: IPX066-B08-05
Study First Received: April 3, 2009
Results First Received: December 7, 2015
Last Updated: January 25, 2016
Health Authority: United States: Food and Drug Administration