Clinical trial NCT00040404: Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Idiopathic Parkinson's disease
Idiopathic Parkinson disease
Parkinson's disease, idiopathic
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
name: The Parkinson Study Group
First posted: 2002-06-27
Enrollment: 806
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish safety for CEP-1347 and to determine an efficacious dose in the treatment of Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

Patients will be included in the study if all of the following criteria are met:

* Willing and able to give informed consent
* Age 30 years or older at time of diagnosis of Parkinson's disease
* Have idiopathic Parkinson's disease with at least 2 cardinal signs of disease: resting tremor, bradykinesia, or rigidity
* Modified Hoehn and Yahr stage less than or equal to 2.5
* Must have had screening procedures for cancer appropriate for the patient's age and gender, within the last 12 months; or be willing to obtain such screening before randomization
* Women: are not breastfeeding
* Women: nonchildbearing potential (ie, postmenopausal or surgically sterile) or 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. Women must be given a pregnancy test unless they are at least 2 years postmenopausal or surgically sterile.

Exclusion Criteria:

Patients will be excluded from participating in this study if 1 or more of the following criteria are met:

* Have atypical Parkinsonism due to drugs, metabolic disorders, encephalitis, or other neurodegenerative diseases
* Have confirmed diagnosis of Parkinson's disease for more than 5 years
* Have a tremor score of 3 or more in any body part
* Have any other known medical or psychiatric condition that may compromise participation in the study
* Have a history of prior malignancy (excluding basal or squamous cell cancer of the skin) within the previous 5 years
* Have an unresolved abnormal cancer screening test result before randomization
* Have greater than trace amounts of glycosuria at screening, except for known diabetic patients
* Have estimated creatinine clearance less than 50 mL/min
* Have liver function tests (LFT) greater than 3 times the upper limit of normal (ULN)
* Have any other clinically significant ECG or laboratory finding
* Have any history of malignant melanoma
* Have history of seizures (except febrile) or posttraumatic epilepsy
* Have Mini-Mental State Exam (MMSE) score ≤ 26
* Have taken another investigational drug within 60 days before the baseline visit
* Have received prior treatment with CEP-1347
* Have received treatment with agents with potentially confounding anti-Parkinson's disease effects, with specified substrates for CYP3A4/5, or with inhibitors of CYP3A4/5
* Received treatment within 6 months before the baseline visit with agents that may induce Parkinson's disease
* Are expected, within the next 3 months, to reach a level of disability sufficient to require dopaminergic therapy
* Have BECK depression score ≥ 15
* Have known or suspected sensitivity to the investigational study drugs, including B-CIT

Primary outcomes:
measure: Number of participants with disability using United Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 48 months
Secondary outcomes:
measure: Change from Baseline to 22 months in ([123I]β-CIT) Uptake Participants
timeFrame: Change from Baseline to 22 months
measure: Safety and Tolerability as assessed by the number of participants experiencing adverse events
timeFrame: 48 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Services
state: Arkansas
city: Fountain Valley
country: United States
facility: The Parkinson's and Movement Disorders Institute
state: California
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Los Angeles
country: United States
facility: USC, Keck School of Pharmacy, Department of Neurology
state: California
city: Oxnard
country: United States
facility: California Medical Clinic for Movement Disorders
state: California
city: Sacramento
country: United States
facility: Department of Neurology - UC Davis Medical Center
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center, Dept. of Neurology
state: California
city: Sunnyvale
country: United States
facility: The Parkinson's Institute
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Englewood
country: United States
facility: Colorado Neurological Institute/Movement Disorders Center
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: Jacksonville
country: United States
facility: Davis Building - Neurology 8-B
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Harbourside Medical Tower
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern University, Department of Neurology
state: Illinois
city: Chicago
country: United States
facility: Rush-Presbyterian-St. Luke's Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University of Medicine/Outpatient Clinical Research Facility
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics, Department of Neurology
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center/Dept. of Neurology
state: Kansas
city: Shreveport
country: United States
facility: LSUHSC in Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University, Department of Neurology
state: Maryland
city: Boston
country: United States
facility: Center for Aging, Genetics and Neurodegeneration, Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Womens Hospital/Neurology
state: Massachusetts
city: Boston
country: United States
facility: Boston University Medical Center, Department of Neurology
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Southfield
country: United States
facility: Clinical Neuroscience Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota, Department of Neurology
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: Creighton University/Department of Neurology
state: Nebraska
city: New Brunswick
country: United States
facility: UMDNJ Robert Wood Johnson Medical Center
state: New Jersey
city: Stratford
country: United States
facility: University of Medicine and Dentistry of New Jersey/Center for Aging
state: New Jersey
city: Albany
country: United States
facility: Parkinson's Disease & Movement Disorders Center of AMC
state: New York
city: Manhasset
country: United States
facility: Movement Disorders Center/North Shore - LIJ Health System
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center, Department of Neurology
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Medical Center, Neurological Institute
state: New York
city: Rochester
country: United States
facility: University of Rochester, Department of Neurology
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Toledo
country: United States
facility: Medical College of Ohio, Department of Neurology
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University/Dept. of Neurology
state: Oregon
city: Philadelphia
country: United States
facility: Pennsylvania Hospital/Dept. of Neurology
state: Pennsylvania
city: Pawtucket
country: United States
facility: Brown University/Memorial Hospital of Rhode Island/Neurology Dept.
state: Rhode Island
city: Memphis
country: United States
facility: University of Tennessee Memphis, Semmes Murphy Clinic
state: Tennessee
city: Houston
country: United States
facility: Parkinson's Disease Center and Movement Disorders Clinic/Baylor College of Medicine
state: Texas
city: Temple
country: United States
facility: Scott and White Clinic/Texas A & M University
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System/Adult Neurology
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin, Department Neurology
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta - Glenrose Rehab Hospital
state: Alberta
city: London
country: Canada
facility: London Health Sciences Center - University Campus
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital, Civic Site
state: Ontario
city: Toronto
country: Canada
facility: Toronto Hospital Western Division
state: Ontario
city: Fleurimont
country: Canada
facility: University of Sherbrooke
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier De L'Universite Montreal
state: Quebec
city: Verdun
country: Canada
facility: McGill Center for Studies in Aging
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon District Health Board - Royal University Hospital
state: Saskatchewan
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico, Clinical Research Center
Study officials:
References:
citation: Schwarzschild MA, Schwid SR, Marek K, Watts A, Lang AE, Oakes D, Shoulson I, Ascherio A; Parkinson Study Group PRECEPT Investigators; Hyson C, Gorbold E, Rudolph A, Kieburtz K, Fahn S, Gauger L, Goetz C, Seibyl J, Forrest M, Ondrasik J. Serum urate as a predictor of clinical and radiographic progression in Parkinson disease. Arch Neurol. 2008 Jun;65(6):716-23. doi: 10.1001/archneur.2008.65.6.nct70003. Epub 2008 Apr 14.
citation: 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.