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

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ClinicalTrials.gov Identifier: NCT00449865
Recruitment Status : Terminated (Futility)
First Posted : March 21, 2007
Results First Posted : April 2, 2015
Last Update Posted : April 2, 2015
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Karl Kieburtz, University of Rochester

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Drug: creatine
Other: placebo

  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
No text entered.

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

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

Baseline Measures
   Placebo   Creatine   Total 
Overall Participants Analyzed 
[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 ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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


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


Responsible Party: Karl Kieburtz, University of Rochester
ClinicalTrials.gov Identifier: NCT00449865     History of Changes
Other Study ID Numbers: U01NS43128 NET-PD
CRC
First Submitted: March 20, 2007
First Posted: March 21, 2007
Results First Submitted: February 19, 2015
Results First Posted: April 2, 2015
Last Update Posted: April 2, 2015