search
Back to results

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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
minocycline
creatine
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, minocycline, creatine, neuroprotection

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Rochester Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 23, 2003
Last Updated
January 19, 2016
Sponsor
University of Rochester
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00063193
Brief Title
National Institute of Neurological Disorders and Stroke (NINDS) Parkinson's Disease Neuroprotection Trial
Official Title
A Multi-center, Double-blind, Pilot Study of Minocycline and Creatine in Subjects With Early Untreated Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, minocycline, creatine, neuroprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
195 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
minocycline
Intervention Type
Drug
Intervention Name(s)
creatine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Kieburtz, M.D., M.P.H.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Tilley, Ph.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24711047
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs