Trial · NCT00449865

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

NCT00449865, Phase 3, Terminated, University of Rochester; results first posted 2015-04-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. NET-PD LS-1 Creatine in Parkinson's Disease. Trials, record NCT00449865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00449865

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: NET-PD LS-1 Creatine in Parkinson's Disease
NCT number: NCT00449865
Status: Terminated
Phases: Phase 3
Enrollment: 1,741 participants, actual
Lead sponsor: University of Rochester
Conditions: Parkinson's Disease
Interventions: creatine, placebo
First posted: 2007-03-21
Last updated: 2015-04-02
Results first posted: 2015-04-02

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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.	Change from baseline to 5 YEARS	All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
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.	Change from baseline to 5 YEARS	Intent-to-Treat sample: n = 955, participants randomized at least 5 years before July 2013 (time of planned interim analysis).	summed-ranks	MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
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.	Placebo		2360	95% Confidence Interval 2249 to 2470	summed-ranks
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.	Creatine		2414	95% Confidence Interval 2304 to 2524	summed-ranks

Source ClinicalTrials.gov

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	867
Overall Study	STARTED	Creatine	874
Overall Study	Completed Year 1	Placebo	802
Overall Study	Completed Year 1	Creatine	822
Overall Study	Completed Year 2	Placebo	768
Overall Study	Completed Year 2	Creatine	766
Overall Study	Completed Year 3	Placebo	719
Overall Study	Completed Year 3	Creatine	715
Overall Study	Completed Year 4	Placebo	521
Overall Study	Completed Year 4	Creatine	523

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events822

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cataract	Eye disorders	Placebo	51	867
other	Cataract	Eye disorders	Creatine	44	874
other	Constipation	Gastrointestinal disorders	Placebo	107	867
other	Constipation	Gastrointestinal disorders	Creatine	121	874
other	Diarrhoea	Gastrointestinal disorders	Placebo	50	867
other	Diarrhoea	Gastrointestinal disorders	Creatine	65	874
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Placebo	53	867
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Creatine	39	874
other	Nausea	Gastrointestinal disorders	Placebo	101	867
other	Nausea	Gastrointestinal disorders	Creatine	99	874

1 to 10 of 822Source ClinicalTrials.gov

See all 822 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Creatine
Total, other adverse events	Placebo	687	867
Total, other adverse events	Creatine	698	874
Total, serious adverse events	Placebo	347	867
Total, serious adverse events	Creatine	315	874

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25668262	DERIVED	PubMed
26751506	DERIVED	PubMed
27573636	DERIVED	PubMed
28712000	DERIVED	PubMed
28972194	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01NS043128	Neuroprotection Studies in PD: A Coordinating Center.	KIEBURTZ, KARL D.	UNIVERSITY OF ROCHESTER	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2001 to 2014

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Creatine vs Placebo: serious adverse events

Source Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Symbol Coding	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00449865

GET https://conductscience.org/api/trials/v1/NCT00449865/events?page=2

API reference For AI assistants