Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Depomed
ClinicalTrials.gov Identifier:
NCT01515410
First received: January 11, 2012
Last updated: January 27, 2014
Last verified: November 2012
Results First Received: November 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Parkinson's Disease
Motor Fluctuations
Interventions: Drug: DM-1992
Drug: Sinemet IR

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 34 subjects were randomly assigned to treatment in this crossover study: 19 in the DM-1992 for Period 1 and Sinemet IR for Period 2 sequence, and 15 in the Sinemet IR for Period 1 and DM-1992 for Period 2 sequence. All 34 subjects received study treatment and were included in the safety and intent-to-treat (ITT) populations.

Reporting Groups
  Description
DM-1992 First, Then Sinemet IR DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD) first, then Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
Sinemet IR First, Then DM-1992 Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD) first, then DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)

Participant Flow:   Overall Study
    DM-1992 First, Then Sinemet IR     Sinemet IR First, Then DM-1992  
STARTED     19     15  
COMPLETED     19     15  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Overall Study DM-1992 first, then Sinemet IR; Sinemet IR first, then DM-1992

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
  34  
Age  
[units: years]
Mean ± Standard Deviation
  61.4  ± 8.41  
Gender  
[units: participants]
 
Female     8  
Male     26  
Race/Ethnicity, Customized  
[units: participants]
 
White     32  
Afro-Caribbean     2  
Native Hawaiian or Other Pacific Islander     0  
Asian     0  
American Indian or Alaskan Native     0  
Hispanic or Latino     0  
Other     0  
Percent "OFF" Time (%) [1]
[units: percentage¬†of¬†time]
Mean ± Standard Deviation
  32.50  ± 9.962  
[1] Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1.



  Outcome Measures

1.  Primary:   The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent "OFF" Time.   [ Time Frame: Baseline and 10 days for each of the 2 study periods ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Head of R&D
Organization: Depomed
phone: 510-744-8000
e-mail: msweeney@depomed.com


No publications provided


Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT01515410     History of Changes
Other Study ID Numbers: 81-0068
Study First Received: January 11, 2012
Results First Received: November 20, 2013
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration