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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 21, 2016
Last verified: September 2013
Results First Received: December 8, 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: 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 Investigational product IPX066
Carbidopa-Levodopa Immediate-release carbidopa and levodopa

Participant Flow for 3 periods

Period 1:   IR CD-LD Dose Adjustment
    IPX066     Carbidopa-Levodopa  
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     Carbidopa-Levodopa  
STARTED     450     0  
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  

Period 3:   Maintenance - Double Blind Treatment
    IPX066     Carbidopa-Levodopa  
STARTED     201     192  
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  



  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  
Number of Participants  
[units: participants]
  201     192     393  
Age  
[units: years]
Mean (Standard Deviation)
  63.1  (10.0)     63.4  (8.8)     63.2  (9.4)  
Gender  
[units: participants]
     
Female     72     67     139  
Male     129     125     254  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     3     8     11  
Not Hispanic or Latino     192     182     374  
Unknown or Not Reported     6     2     8  
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
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1.  Primary:   Percentage of "Off" Time During Waking Hours at End of Study   [ Time Frame: 22 weeks ]

2.  Secondary:   "Off" Time Hours   [ 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 21, 2016
Health Authority: United States: Food and Drug Administration