National Institute of Neurological Disorders and Stroke (NINDS) Parkinson's Disease Neuroprotection Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00063193
First received: June 23, 2003
Last updated: October 2, 2009
Last verified: October 2009
  Purpose

The goal of this study is to assess the impact of minocycline and creatine on the progression of Parkinson's disease, in order to determine whether it is reasonable to proceed with further study of either of these agents.


Condition Intervention Phase
Parkinson's Disease
Drug: minocycline
Drug: creatine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Pilot Study of Minocycline and Creatine in Subjects With Early Untreated Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Estimated Enrollment: 195
Study Start Date: May 2003
Study Completion Date: July 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Detailed Description:

Parkinson's disease (PD) affects nearly a million Americans, a number that will increase over the coming decades as the population ages. While available medical therapies are usually effective for controlling symptoms in the initial years following diagnosis, higher doses of multiple agents are required over time, with increasing side effects and incomplete control of symptoms. Although these treatments can dramatically improve the lives of patients with PD initially, they do not address the underlying causes of the disease or the inevitable disease progression.

This multi-center, randomized, double-blind trial will involve 42 trial centers in the United States and Canada, and enroll 195 people with PD. The primary objective of this neuroprotection trial is to identify agents capable of slowing the progression of PD. In the trial, investigators will assess the impact of minocycline and creatine on the progression of PD and determine if it is futile or non-futile to proceed with further study of these agents.

In this study, subjects with early, untreated PD will be equally randomized into one of the three study arms: 1.) the group that receives active minocycline and placebo instead of creatine, 2.) the group that receives active creatine and placebo instead of minocycline, or 3.) the group that receives placebo instead of minocycline and creatine. Subjects will remain on the blinded study drug for 18 months.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Willing and able to give informed consent.
  • Men and women with idiopathic PD of less than 5 years duration from diagnosis.
  • Diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity) being present, without any other known or suspected cause of parkinsonism. The clinical signs must be asymmetric.
  • Subjects must not require any therapy (including levodopa, dopamine agonists, anticholinergics, amantadine or selegiline) to treat symptoms of PD at the time of enrollment. Subjects may have had prior exposure to any one of these agents, but exposure with any agent may not have been longer than 60 days in duration and subjects must not have been on any of these agents within 90 days prior to baseline. Once a subject needs dopaminergic treatment, these medications may be added as part of best medical management. The subject will still remain in the study.
  • Age > 30 years.
  • Willingness and ability to comply with study requirements.
  • Women of childbearing potential (i.e., those not postmenopausal or surgically sterile) may participate provided that they are using adequate birth control methods for the duration of the study. Women of childbearing potential must have a negative pregnancy test at baseline and be non-lactating.

Exclusion:

  • Use of any of the following drugs within 180 days prior to baseline: neuroleptics, metoclopramide, alpha-methyldopa, clozapine, olanzapine and flunarizine.
  • Use of any of the following drugs within 90 days prior to baseline: methylphenidate, cinnarizine, reserpine, amphetamine or MAO-A inhibitors (pargyline, phenelzine, and tranylcypromine).
  • Presence of atypical Parkinson's syndromes due to drugs (e.g., metoclopramide, flunarazine), metabolic identified neurogenetic disorders (e.g., Wilson's disease), encephalitis, or other degenerative diseases (e.g., progressive supranuclear palsy).
  • Use of minocycline or creatine 90 days prior to baseline.
  • Use of CoQ10> 300mg 90 days prior to baseline. Subjects must maintain a stable dosage of CoQ10 throughout the duration of the trial.
  • Participation in other drug studies or receipt of other investigational drugs within 90 days prior to baseline.
  • Presence of freezing.
  • Impairment of postural reflexes (pull test score >0).
  • Any clinically significant medical condition (e.g., active GI illness, angina, active neoplasm) or laboratory abnormality, which would in the the judgment of the investigator interfere with the subjects ability to participate in the study or to be followed.
  • History of stereotaxic brain surgery for PD (e.g., pallidotomy, deep brain stimulation, fetal tissue implantation).
  • Clinically significant structural brain disease that the investigator believes would interfere with study evaluations.
  • History of known hypersensitivity or intolerability to minocycline or known allergy to any tetracycline or creatine.
  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: NCT00063193

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14620
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Karl Kieburtz, M.D., M.P.H. University of Rochester
Principal Investigator: Barbara Tilley, Ph.D. Medical University of South Carolina
  More Information

No publications provided by University of Rochester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karl Kieburtz, MD, MPH, Clinical Trials Coordination Center, University of Rochester
ClinicalTrials.gov Identifier: NCT00063193     History of Changes
Other Study ID Numbers: U01NS43128
Study First Received: June 23, 2003
Last Updated: October 2, 2009
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
Parkinson's disease
minocycline
creatine
neuroprotection

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014