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A Longitudinal Observational Follow-up of the PRECEPT Study Cohort (PostCEPT)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
H. Lundbeck A/S
Parkinson's Disease Foundation
Information provided by:
The Parkinson Study Group
ClinicalTrials.gov Identifier:
NCT00605163
First received: January 17, 2008
Last updated: March 26, 2008
Last verified: March 2008

January 17, 2008
March 26, 2008
August 2006
August 2010   (final data collection date for primary outcome measure)
Unified Parkinson Disease Rating Scale (UPDRS) and β-CIT SPECT imaging of the dopamine transporter. [ Time Frame: Annual, ongoing assessments ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00605163 on ClinicalTrials.gov Archive Site
University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: Annual, ongoing assessments ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Longitudinal Observational Follow-up of the PRECEPT Study Cohort
A Longitudinal Observational Follow-up of the PRECEPT Study Cohort

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.

Not Provided
Observational
Observational Model: Cohort
Not Provided
Retention:   Samples With DNA
Description:

Whole blood

Non-Probability Sample

Parkinson disease patients who participated in the PRECEPT clinical trial.

Parkinson Disease
Not Provided
Not Provided
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. Epub 2007 Sep 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
530
Not Provided
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients will be excluded from participating in the the study if either of the criteria stated above is not met
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00605163
U01NS050095_PostCEPT, NINDS 5 U01NS050095-02
No
Ira Shoulson, MD, Principal Investigator, University of Rochester Clinical Trials Coordination Center
The Parkinson Study Group
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • H. Lundbeck A/S
  • Parkinson's Disease Foundation
  • Department of Defense
Not Provided
The Parkinson Study Group
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP