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

NCT ID: NCT00063193

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2005-07-31

Brief Summary

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.

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

minocycline

Intervention Type: DRUG

creatine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Karl Kieburtz

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karl Kieburtz, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Barbara Tilley, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

References

Parashos SA, Luo S, Biglan KM, Bodis-Wollner I, He B, Liang GS, Ross GW, Tilley BC, Shulman LM; NET-PD Investigators. Measuring disease progression in early Parkinson disease: the National Institutes of Health Exploratory Trials in Parkinson Disease (NET-PD) experience. JAMA Neurol. 2014 Jun;71(6):710-6. doi: 10.1001/jamaneurol.2014.391.

Reference Type: DERIVED

PMID: 24711047 (View on PubMed)

Other Identifiers

U01NS043128

Identifier Type: NIH

Identifier Source: org_study_id

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