Parkinson DiseasePhase 2NCT00076492
NINDS Parkinson's Disease Neuroprotection Trial of CoQ10 and GPI 1485
A Phase 2 study testing CoQ10 and GPI 1485 in people with Parkinson Disease, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- CoQ10 and GPI 1485
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Sep 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14620
About this study
Official title: A Multi-center, Double-blind, Pilot Study of CoQ10 and GPI 1485 in Subjects With Early Untreated Parkinson's Disease
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.
Read the 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 CoQ10, an antioxidant, and GPI 1485, a novel immunophilin compound, 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 CoQ10 and placebo instead of GPI 1485; 2.) the group that receives active GPI 1485 and placebo instead of CoQ10; or 3.) the group that receives placebo instead of CoQ10 and GPI 1485. Subjects will remain on the blinded study drug for 12 months.
- Conditions
- Parkinson Disease
- Being tested
- CoQ10, GPI 1485
- Keywords
- Parkinson's disease, Parkinson disease, CoQ10, GPI 1485
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoQ10Drug
GPI 1485Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2004 (estimated)
- Study startJan 2004
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 195 participants
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl Kieburtz, University of Rochester
- Investigators
- Karl Kieburtz, MD, MPH, Principal investigator, University of RochesterBarbara Tilley, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076492
- Sponsor's protocol ID
- U01NS43128-2
- Other IDs
- U01NS043128
- Status last verified
- Oct 2012
- First submitted
- 23 Jan 2004
- Last updated
- 2 Nov 2012
- Results posted
- No
Publications
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.
PubMed 24711047
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Pilot Study of CoQ10 and GPI 1485 in Subjects With Early Untreated Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00076492
- Acronym / sponsor ID
- U01NS43128-2
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Parkinson disease, CoQ10, GPI 1485
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jan 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 27 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 CoQ10, an antioxidant, and GPI 1485, a novel immunophilin compound, 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 CoQ10 and placebo instead of GPI 1485; 2.) the group that receives active GPI 1485 and placebo instead of CoQ10; or 3.) the group that receives placebo instead of CoQ10 and GPI 1485. Subjects will remain on the blinded study drug for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoQ10 | Drug | – |
| GPI 1485 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2012.
- Derived from this study: PubMed 24711047Parashos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Kieburtz, MD, MPH principal investigator
University of Rochester
Barbara Tilley, Ph.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CoQ10 and GPI 1485 in people with Parkinson Disease, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00076492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2012.