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Trial record 1 of 1 for:    IPX066-B11-01
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Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study

This study has been completed.
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT01411137
First received: August 4, 2011
Last updated: April 18, 2017
Last verified: April 2017
Results First Received: March 3, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Intervention: 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
Date first subject enrolled: August 19, 2011 Date last subject completed: March 20, 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IPX066 extended-release CD-LD

Participant Flow for 3 periods

Period 1:   Part 1: Dose Conversion
    IPX066
STARTED   43 
COMPLETED   33 
NOT COMPLETED   10 

Period 2:   Part 2: Open-Label Extension
    IPX066
STARTED   32 [1] 
COMPLETED   25 
NOT COMPLETED   7 
[1] 1 subject who completed Part 1 did not elect to continue into Part 2.

Period 3:   Part 3: Open-Label Extension
    IPX066
STARTED   12 [1] 
COMPLETED   12 
NOT COMPLETED   0 
[1] Two sites with 11 completers of Part 2 did not participate in Part 3. Two subjects lost contact.



  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
All Study Participants

Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.

Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.

Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, an additional 6-month open-label extension study.


Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 43 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      20  46.5% 
>=65 years      23  53.5% 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.4  (10.49) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      23  53.5% 
Male      20  46.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      43 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   2.3% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      42  97.7% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   43 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Patient Global Impression (PGI)   [ Time Frame: 6 months ]

2.  Primary:   Clinical Global Impression (CGI)   [ Time Frame: 6 months ]

3.  Primary:   Parkinson’s Disease Questionnaire-8 (PDQ-8)   [ Time Frame: 6 months ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Michelle Landolfi, Senior Director, Regulatory Affairs
Organization: Impax Laboratories, Inc.
phone: (510) 240-6496
e-mail: Michelle.Landolfi@impaxlabs.com


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

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01411137     History of Changes
Other Study ID Numbers: IPX066-B11-01
Study First Received: August 4, 2011
Results First Received: March 3, 2016
Last Updated: April 18, 2017