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A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00974974
First received: September 10, 2009
Last updated: January 20, 2017
Last verified: January 2017
Results First Received: December 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Drug: IPX066
Drug: IR CD-LD

  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
Study period was form September 29, 2009 to January 19, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, subjects needed to complete a 3-week dose adjustment of IR CD-LD followed by 6-week dose conversion to IPX066.

Reporting Groups
  Description
IPX066 Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
IR CD-LD (Active Comparator) Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).

Participant Flow for 3 periods

Period 1:   IR CD-LD Dose Adjustment
    IPX066   IR CD-LD (Active Comparator)
STARTED   0   471 
COMPLETED   0   450 
NOT COMPLETED   0   21 
Adverse Event                0                3 
Protocol Violation                0                1 
Noncompliance with study drug                0                1 
Withdrawal by Subject                0                7 
Various                0                9 

Period 2:   IPX066 Dose Conversion
    IPX066   IR CD-LD (Active Comparator)
STARTED   450 [1]   0 [2] 
COMPLETED   393   0 
NOT COMPLETED   57   0 
Adverse Event                23                0 
Death                2                0 
Lack of Efficacy                13                0 
Withdrawal by Subject                12                0 
Various                3                0 
Protocol Violation                4                0 
[1] All subjects who completed IR Dose adjustment entered into IPX066 dose conversion.
[2] IR is not applicable in IPX066 dose conversion.

Period 3:   Maintenance - Double Blind Treatment
    IPX066   IR CD-LD (Active Comparator)
STARTED   201 [1]   192 [1] 
COMPLETED   186   182 
NOT COMPLETED   15   10 
Adverse Event                3                3 
Protocol Violation                1                1 
Noncompliance with study drug                0                1 
Lack of Efficacy                2                2 
Lost to Follow-up                0                1 
Withdrawal by Subject                5                2 
Various                4                0 
[1] All subjects who completed IPX066 Dose Conversion were randomized to either IPX066 or IR.



  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.
All treated

Reporting Groups
  Description
IPX066 Investigational product IPX066
Carbidopa-Levodopa Immediate-release carbidopa and levodopa
Total Total of all reporting groups

Baseline Measures
   IPX066   Carbidopa-Levodopa   Total 
Overall Participants Analyzed 
[Units: Participants]
 201   192   393 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.1  (10.0)   63.4  (8.8)   63.2  (9.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      72  35.8%      67  34.9%      139  35.4% 
Male      129  64.2%      125  65.1%      254  64.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      3   1.5%      8   4.2%      11   2.8% 
Not Hispanic or Latino      192  95.5%      182  94.8%      374  95.2% 
Unknown or Not Reported      6   3.0%      2   1.0%      8   2.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   196   186   382 
Black or African American   2   1   3 
Asian   1   1   2 
American Indian or Alaskan Native   0   2   2 
Other   1   2   3 
Unknown   1   0   1 
Region of Enrollment 
[Units: Participants]
     
Canada   10   8   18 
Romania   3   4   7 
United States   98   93   191 
Ukraine   37   38   75 
Poland   34   33   67 
France   2   1   3 
Germany   12   11   23 
Spain   5   4   9 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of "Off" Time During Waking Hours at End of Study   [ Time Frame: 22 weeks ]

2.  Secondary:   "Off" Time   [ Time Frame: 22 weeks ]

3.  Secondary:   "On" Time Without Troublesome Dyskinesia   [ Time Frame: 22 weeks ]


  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: Michelle Landolfi, Director, Regulatory Affairs
Organization: Impax Laboratories, Inc.
phone: 510-240-6402
e-mail: mlandolfi@impaxlabs.com


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

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00974974     History of Changes
Other Study ID Numbers: IPX066-B09-02
Study First Received: September 10, 2009
Results First Received: December 8, 2015
Last Updated: January 20, 2017