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

January 19, 2016 updated by: Karl Kieburtz, University of Rochester

A Multi-center, Double-blind, Pilot Study of Minocycline and Creatine in Subjects With Early Untreated Parkinson's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

195

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14620
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Karl Kieburtz, M.D., M.P.H., University of Rochester
  • Principal Investigator: Barbara Tilley, Ph.D., Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

June 23, 2003

First Submitted That Met QC Criteria

June 24, 2003

First Posted (Estimate)

June 25, 2003

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01NS043128 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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