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

This study has been terminated.

(Futility)

Sponsor:

Collaborator:

National Institute of Neurological Disorders and Stroke (NINDS)

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

History of Changes

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
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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 ]

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Serious Adverse Events

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Other Adverse Events

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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

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

Wills AM, Pérez A, Wang J, Su X, Morgan J, Rajan SS, Leehey MA, Pontone GM, Chou KL, Umeh C, Mari Z, Boyd J; NINDS Exploratory Trials in Parkinson Disease (NET-PD) Investigators. Association Between Change in Body Mass Index, Unified Parkinson's Disease Rating Scale Scores, and Survival Among Persons With Parkinson Disease: Secondary Analysis of Longitudinal Data From NINDS Exploratory Trials in Parkinson Disease Long-term Study 1. JAMA Neurol. 2016 Mar;73(3):321-8. doi: 10.1001/jamaneurol.2015.4265.

Writing Group for the NINDS Exploratory Trials in Parkinson Disease (NET-PD) Investigators, Kieburtz K, Tilley BC, Elm JJ, Babcock D, Hauser R, Ross GW, Augustine AH, Augustine EU, Aminoff MJ, Bodis-Wollner IG, Boyd J, Cambi F, Chou K, Christine CW, Cines M, Dahodwala N, Derwent L, Dewey RB Jr, Hawthorne K, Houghton DJ, Kamp C, Leehey M, Lew MF, Liang GS, Luo ST, Mari Z, Morgan JC, Parashos S, Pérez A, Petrovitch H, Rajan S, Reichwein S, Roth JT, Schneider JS, Shannon KM, Simon DK, Simuni T, Singer C, Sudarsky L, Tanner CM, Umeh CC, Williams K, Wills AM. Effect of creatine monohydrate on clinical progression in patients with Parkinson disease: a randomized clinical trial. JAMA. 2015 Feb 10;313(6):584-93. doi: 10.1001/jama.2015.120.

Responsible Party:	Karl Kieburtz, University of Rochester
ClinicalTrials.gov Identifier:	NCT00449865 History of Changes
Other Study ID Numbers:	U01NS043128-NET-PD ( US NIH Grant/Contract Award Number ) 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

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