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: November 3, 2013
Last verified: November 2013
  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:


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: June 2014
Primary Completion Date: September 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 50 Study Locations
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Karl Kieburtz, MD Coordination Center
Principal Investigator: Barbara Tilley, PhD Statistics Center
  More Information

Additional Information:
No publications provided

Responsible Party: Karl Kieburtz, Principal Investigator, 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: November 3, 2013
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
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 23, 2014