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

NCT00063193 | Completed Phase 2 DMC

• 1 other identifier: U01NS043128
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; minocycline; creatine; neuroprotection

Interventions

minocycline DRUG

creatine DRUG

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

Related Publications (1)

• 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.

  PMID: 24711047 DERIVED

MeSH Terms

Conditions

Parkinson Disease; cyclopia sequence

Interventions

Minocycline; Creatine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Guanidines; Amidines; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Karl Kieburtz, M.D., M.P.H.

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Barbara Tilley, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2003
• First Posted: June 25, 2003
• Study Start: May 1, 2003
• Primary Completion: May 1, 2005
• Study Completion: July 1, 2005
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

US (1)