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Parkinson DiseasePostCEPTNCT00605163

A Longitudinal Observational Follow-up of the PRECEPT Study Cohort

An observational study of Parkinson Disease, run by The Parkinson Study Group at 55 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to longitudinally follow consenting clinical trial participants who participated in PRECEPT (A Randomized, Double Blind, Placebo Controlled, Dose Finding Study to Assess the Efficacy and Safety of CEP 1347 in Patients With Early Parkinson's Disease). Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson Disease
How many people
530 participants
Where
55 sitesin 2 countries
Study dates
Aug 2006to Aug 2010
Phase
Observational
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

Study population: Parkinson disease patients who participated in the PRECEPT clinical trial.

Who may be able to join

  • Participation in the PRECEPT study
  • Willing and able to give informed consent

Who cannot join

  • Patients will be excluded from participating in the the study if either of the criteria stated above is not met

Trial locations and contacts

55 sites in 2 countries.

55 sites in 2 countries

United States47 sites

  • Albany Medical College

    Albany, New York

  • Medical College of Georgia

    Augusta, Georgia

  • University of Colorado Health Sciences Center

    Aurora, Colorado

  • Johns Hopkins University

    Baltimore, Maryland

  • University of Maryland School of Medicine

    Baltimore, Maryland

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts

  • Boston University

    Boston, Massachusetts

  • Brigham & Women's Hospital

    Boston, Massachusetts

  • Massachusetts General Hospital

    Boston, Massachusetts

  • University of Virginia

    Charlottesville, Virginia

  • Northwestern University

    Chicago, Illinois

  • Rush University Medical Center

    Chicago, Illinois

  • University of Chicago

    Chicago, Illinois

  • University of Cincinnati/Cincinnati Children's Hospital

    Cincinnati, Ohio

  • Duke University Medical Center

    Durham, North Carolina

  • The Parkinson's & Movement Disorder Institute

    Fountain Valley, California

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania

  • Baylor College of Medicine

    Houston, Texas

  • University of Iowa

    Iowa City, Iowa

  • University of California Irvine

    Irvine, California

  • Mayo Clinic Jacksonville

    Jacksonville, Florida

  • University of Kansas Medical Center

    Kansas City, Kansas

  • University of San Diego

    La Jolla, California

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas

  • Colorado Neurological Institute

    Littleton, Colorado

  • University of Southern California

    Los Angeles, California

  • North Shore-LIJ Health System

    Manhasset, New York

  • University of Tennessee-Memphis

    Memphis, Tennessee

  • University of Minnesota

    Minneapolis, Minnesota

  • UMDNJ Robert Wood Johnson Medical School

    New Brunswick, New Jersey

  • Institute for Neurogenerative Disorders

    New Haven, Connecticut

  • Beth Israel Medical Center

    New York, New York

  • Columbia University

    New York, New York

  • Creighton University

    Omaha, Nebraska

  • Pacific Neuroscience Medical Group

    Oxnard, California

  • University of Pennsylvania

    Philadelphia, Pennsylvania

  • Barrow Neurological Institute

    Phoenix, Arizona

  • Oregon Health & Science University

    Portland, Ohio

  • University of Rochester

    Rochester, New York

  • University of California Davis

    Sacramento, California

  • LSU Health Science Center Shreveport

    Shreveport, Louisiana

  • Sun Health Research Institute

    Sun City, Arizona

  • The Parkinson's Institute

    Sunnyvale, California

  • University of South Florida

    Tampa, Florida

  • Medical University of Ohio

    Toledo, Ohio

  • NeuroHealth Parkinson's Disease Movement Disorders Center

    Warwick, Rhode Island

  • Cleveland Clinic Florida-Weston

    Weston, Florida

Other trials in United States

Canada8 sites

  • University of Calgary

    Calgary, Alberta

  • University of Alberta

    Edmonton, Alberta

  • University of Sherbrooke

    Fleurimont, Quebec

  • London Health Sciences Centre

    London, Ontario

  • Hotel-Dieu Hospital-CHUM

    Montreal, Quebec

  • Ottawa Hospital Civic Site

    Ottawa, Ontario

  • Saskatoon Disrict Health Board Royal University Hospital

    Saskatoon, Saskatchewan

  • Toronto Western Hospital, University Health Network

    Toronto, Ontario

Other trials in Canada

About this study

The purpose of this study is to longitudinally follow consenting clinical trial participants who participated in PRECEPT (A Randomized, Double Blind, Placebo Controlled, Dose Finding Study to Assess the Efficacy and Safety of CEP 1347 in Patients With Early Parkinson's Disease). The study will assess the clinical and imaging outcomes relevant to the natural history of Parkinson's disease (PD), as well as determine early biomarkers of the disease.

Keywords
Parkinson disease, observational, longitudinal
Medical subject headings
Parkinson Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Unified Parkinson Disease Rating Scale (UPDRS) and β-CIT SPECT imaging of the dopamine transporter.

    Measured: Annual, ongoing assessments

Secondary outcomes (1)

  1. University of Pennsylvania Smell Identification Test (UPSIT)

    Measured: Annual, ongoing assessments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2008 (estimated)
  2. Study startAug 2006
  3. Primary completionAug 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Enrolment
530 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00605163
Sponsor's protocol ID
U01NS050095_PostCEPT
Other IDs
NINDS 5 U01NS050095-02, U01NS050095
Acronym
PostCEPT
Status last verified
Mar 2008
First submitted
17 Jan 2008
Last updated
28 Mar 2008
Results posted
No
Data monitoring committee
No

Publications

  • Parkinson Study Group PRECEPT Investigators. Mixed lineage kinase inhibitor CEP-1347 fails to delay disability in early Parkinson disease. Neurology. 2007 Oct 9;69(15):1480-90. doi: 10.1212/01.wnl.0000277648.63931.c0. Epub 2007 Sep 19.

    PubMed 17881719

  • Latourelle JC, Beste MT, Hadzi TC, Miller RE, Oppenheim JN, Valko MP, Wuest DM, Church BW, Khalil IG, Hayete B, Venuto CS. Large-scale identification of clinical and genetic predictors of motor progression in patients with newly diagnosed Parkinson's disease: a longitudinal cohort study and validation. Lancet Neurol. 2017 Nov;16(11):908-916. doi: 10.1016/S1474-4422(17)30328-9. Epub 2017 Sep 25.

    PubMed 28958801

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by The Parkinson Study Group at 55 sites in 2 countries.

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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Canada. 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.

Are results available for this study?

Results are not available in the source record.

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.

What does the primary outcome measure?

Unified Parkinson Disease Rating Scale (UPDRS) and β-CIT SPECT imaging of the dopamine transporter. (time frame: Annual, ongoing assessments). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00605163, which also lists 2 linked publications.

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 28 Mar 2008.

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