NINDS Parkinson's Disease Neuroprotection Trial of CoQ10 and GPI 1485

NCT00076492 | Completed Phase 2

• 2 other identifiers: U01NS43128-2U01NS043128
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess the impact of CoQ10 and GPI 1485 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 Disease

Keywords

Parkinson's disease; Parkinson disease; CoQ10; GPI 1485

Interventions

CoQ10 DRUG

GPI 1485 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 who are not postmenopausal or surgically sterile must use a medically accepted contraceptive regimen for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Reliable forms of contraception include oral, implanted, or injected contraceptives; intrauterine devices in place for at least 3 months; or adequate barrier methods in conjunction with spermicide (abstinence is considered an acceptable contraceptive regimen). Women must have a pregnancy test unless they are at least 2 years postmenopausal or surgically sterile.

You may not qualify if:

• Use of any of the following drugs within 180 days prior to baseline: neuroleptics, metoclopramide, alpha-methyldopa, clozapine, olanzepine, 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 CoQ10 or GPI 1485 90 days prior to baseline.
• Use of minocycline or creatine 90 days prior to baseline.
• 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 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.
• Significant psychiatric disorders that may interfere with complying with the protocol.
• History of known hypersensitivity or intolerability to CoQ10 or GPI 1485.

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

Interventions

coenzyme Q10; GPI 1485

Condition Hierarchy (Ancestors)

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

Study Officials

• Karl Kieburtz, MD, MPH

  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: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2004
• First Posted: January 27, 2004
• Study Start: January 1, 2004
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: November 2, 2012

Record last verified: 2012-10

Locations

US (1)