NET-PD LS-1 Creatine in Parkinson's Disease - Full Text View

Sponsor:	University of Rochester
Collaborator:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00449865

Purpose

The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.

Condition	Intervention	Phase
Parkinson's Disease	Drug: creatine Other: placebo	Phase 3

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
Official Title:	A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1)

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Perry syndrome

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

using a global statistical test this study will compare disease progression at 5 years between the creatine and placebo groups. [ Time Frame: MINIMUM OF 5 YEARS TO A MAXIMUM OF 7 YEARS ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

comparison of creatine and placebo groups on efficacy, safety and tolerability between baseline and 5 years of follow-up. [ Time Frame: MINIMUM OF 5 YEARS TO A MAXIMUM OF 7 YEARS ] [ Designated as safety issue: Yes ]

Enrollment:	1741
Study Start Date:	March 2007
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1	Other: placebo an inactive substance
Active Comparator: 2 creatine	Drug: creatine Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells. The study is comparing creatine 5 grams twice daily with placebo.

Detailed Description:

Parkinson's disease (PD) affects nearly a million Americans, a number that will increase over the coming decades as the population ages. Symptoms of PD may include tremor, rigidity or stiffness of the limbs and trunk, slowness of movement, and impaired balance and coordination. These problems occur because as PD worsens, some of the brain cells that control body movement die.

This study will determine if creatine——an investigational compound——is able to slow the progression of PD. Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.

In the NET-PD LS-1 study, 1,720 participants will be randomly assigned to receive either creatine or a placebo (inactive substance). Participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Willing and able to give informed consent and willing to commit to long-term follow-up
PD (asymmetric features including slowness (bradykinesia) plus resting tremor and/or rigidity) within 5 years of diagnosis
Treated/responsive to dopaminergic therapy (dopamine agonists or levodopa) for at least 90 days, but not more than 2 years.

Exclusion Criteria:

Use of creatine 14 days prior to baseline or during the study
History of known hypersensitivity or intolerability to creatine
Any unstable or clinically significant condition that would impair the subject's ability to comply with long term study follow-up
Other know or suspected causes of parkinsonism (e.g. metabolic, drug induced, etc.), or any significant features suggestive of a diagnosis of atypical parkinsonism.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449865

Show 50 Study Locations

Sponsors and Collaborators

University of Rochester

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:	Karl Kieburtz, MD	Coordination Center
Principal Investigator:	Barbara Tilley, PhD	Statistics Center

More Information

Additional Information:

NET PD website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Karl Kieburtz, MD, MPH, Clinical Trials Coordination Center, University of Rochester
ClinicalTrials.gov Identifier:	NCT00449865 History of Changes
Other Study ID Numbers:	U01NS43128 NET-PD, CRC
Study First Received:	March 20, 2007
Last Updated:	October 12, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Rochester:

Parkinson's disease
creatine
NET-PD
neuroprotection
PD

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 22, 2012