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A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00869791
First received: March 24, 2009
Last updated: March 21, 2017
Last verified: March 2017
Results First Received: January 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: No masking;   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
35 subjects were screened. 8 were screen failures (did to not meet inclusion/exclusion criteria) and 27 were randomized. Date of first patient enrolled: November 25, 2008 Date last patient completed: June 11, 2009 The study was conducted at 6 sites in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
27 participants were enrolled, treated and completed the treatment with this protocol.

Reporting Groups
  Description
IPX066 First (7 Days), Washout (7 Days) Then IR CD-LD (7 Days) In this arm there were 2 treatment periods of one week each. During period 1, 14 subjects received 7 days of IPX066 first. Then subjects returned to their pre-study regimen during the washout period of approximately 1 week. This was followed by Period 2. During period 2, the 14 subjects received IR CD-LD for 7 days.
IR CD-LD First ( 7 Days), Washout (7 Days) Then IPX066 (7days) In this arm there were 2 treatment periods of one week each. During period 1, 13 subjects received 7 days of IR CD-LD first. Then subjects returned to their pre-study regimen during the washout period of approximately 1 week. This was followed by Period 2. During period 2, the 13 subjects received IPX066 for 7 days.

Participant Flow for 2 periods

Period 1:   Period 1 Treatment for 7 Days
    IPX066 First (7 Days), Washout (7 Days) Then IR CD-LD (7 Days)   IR CD-LD First ( 7 Days), Washout (7 Days) Then IPX066 (7days)
STARTED   14   13 
COMPLETED   14   13 
NOT COMPLETED   0   0 

Period 2:   Period 2 Treatment for 7 Days
    IPX066 First (7 Days), Washout (7 Days) Then IR CD-LD (7 Days)   IR CD-LD First ( 7 Days), Washout (7 Days) Then IPX066 (7days)
STARTED   14   13 
COMPLETED   14   13 
NOT COMPLETED   0   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.
No text entered.

Reporting Groups
  Description
All Study Participants Participants who were randomized to receive either IPX066 or IR CD-LD

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 27 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.7  (8.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  22.2% 
Male      21  77.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   3.7% 
Not Hispanic or Latino      26  96.3% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      3  11.1% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      24  88.9% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   27 


  Outcome Measures
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1.  Primary:   Pharmacokinetics Measurements to Determine Cmax for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.   [ Time Frame: Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm 2 (CD-LD IR first, washout, then IPX066) ]

2.  Primary:   Pharmacokinetics Measurements to Determine Tmax for Levodopa and Carbidopa Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.   [ Time Frame: Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066 ]

3.  Primary:   Pharmacokinetics Measurements to Determine Area Under the Concentration-time Curve for the Dosing Interval for LD and CD Concentrations From Blood Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Treatment Arms.   [ Time Frame: Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066 ]

4.  Primary:   Dosing Interval Tau in Hours, for Levodopa and Carbidopa Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.   [ Time Frame: Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066 ]

5.  Secondary:   8-Hour Efficacy Using Day 1 Tapping   [ Time Frame: Day 1 of each treatment period - three times prior to dosing in the clinic, and at half-hour intervals through the 8-hour measurement period ]

6.  Secondary:   8-Hour Efficacy Using Day 1 Unified Parkinson’s Disease Rating Scale Part III Score   [ Time Frame: Pre dosing and at hourly intervals through the 8-hour measurement period on day 1 ]

7.  Secondary:   Result Summary of Day 1 Dyskinesia Evaluated by Investigator Assessment for Each Treatment Period   [ Time Frame: Predose and then every 30 min upto 8 h after dosing on Day of 1 of each treatment period ]

8.  Secondary:   "Off" Time Hours Reported by Subjects Using Parkinson's Patient Diary   [ Time Frame: Last 3 days of each treatment period, every 30 minutes over a 24-hour day beginning at 6:00 AM ]


  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
The limitations of this study include its relatively small size, multiple statistical testing, short study durations, and open-label design.


  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, PhD. Sr. Director, Regulatory Affairs
Organization: Impax Laboratories, Inc.
phone: (510) 240-6496
e-mail: Michelle.Landolfi@impaxlabs.com


Publications:

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00869791     History of Changes
Other Study ID Numbers: IPX066-B08-11
Study First Received: March 24, 2009
Results First Received: January 25, 2016
Last Updated: March 21, 2017