NET-PD LS-1 Creatine in Parkinson's Disease

This study has been terminated.
(Futility)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Karl Kieburtz, University of Rochester
ClinicalTrials.gov Identifier:
NCT00449865
First received: March 20, 2007
Last updated: March 23, 2015
Last verified: March 2015
Results First Received: February 19, 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: creatine
Other: placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo placebo: an inactive substance
Creatine creatine monohydrate (10 gram /day)

Participant Flow:   Overall Study
    Placebo     Creatine  
STARTED     867     874  
Completed Year 1     802 [1]   822 [2]
Completed Year 2     768 [3]   766 [4]
Completed Year 3     719 [5]   715 [6]
Completed Year 4     521 [7]   523 [8]
COMPLETED     345 [9]   340 [10]
NOT COMPLETED     522     534  
Withdrawal by Subject                 110                 110  
Lost to Follow-up                 36                 37  
Physician Decision                 13                 12  
Death                 31                 40  
Protocol Violation                 8                 7  
Study was stopped                 324                 328  
[1] 867 Expected at Year 1
[2] 874 Expected at Year 1
[3] 867 Expected at Year 2
[4] 874 Expected at Year 2
[5] 867 Expected at Year 3
[6] 874 Expected at Year 3
[7] 679 Expected at Year 4
[8] 686 Expected at Year 4
[9] 478 Expected at Year 5
[10] 477 Expected at Year 5



  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.
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Reporting Groups
  Description
Placebo placebo: an inactive substance
Creatine creatine 5 grams twice daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Creatine     Total  
Number of Participants  
[units: participants]
  867     874     1741  
Age  
[units: years]
Mean ± Standard Deviation
  61.5  ± 9.6     62.1  ± 9.7     61.8  ± 9.6  
Gender  
[units: participants]
     
Female     313     305     618  
Male     554     569     1123  
Time since diagnosis, y  
[units: years]
Mean ± Standard Deviation
  1.6  ± 1.1     1.5  ± 1.1     1.5  ± 1.1  
Total Unified Parkinson's Disease Rating Scale (UPDRS) [1]
[units: units on a scale]
Mean ± Standard Deviation
  25.9  ± 11     26.5  ± 11.7     26.2  ± 11.4  
[1] The total UPDRS is the sum of parts I, II, and III. The possible range of the total UPDRS is from 0-176. Higher values indicate worse outcomes.



  Outcome Measures

1.  Primary:   The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson’s Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years.   [ Time Frame: Change from baseline to 5 YEARS ]


  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 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: Karl Kieburtz, Director of CTSI
Organization: University of Rochester
phone: 585-275-0553
e-mail: Karl.kieburtz@chet.rochester.edu


No publications provided by University of Rochester

Publications automatically indexed to this study:

Responsible Party: Karl Kieburtz, University of Rochester
ClinicalTrials.gov Identifier: NCT00449865     History of Changes
Other Study ID Numbers: U01NS43128 NET-PD, CRC
Study First Received: March 20, 2007
Results First Received: February 19, 2015
Last Updated: March 23, 2015
Health Authority: United States: Food and Drug Administration