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

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)

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.