Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00040404
• Other study ID #: C1347c/204/PD/US-CA
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: June 26, 2002
• Last updated: May 8, 2012
• Start date: March 2002
• Est. completion date: August 2005

Study information

• Verified date: May 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 806
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• CEP-1347 10mg
CEP-1347 10mg, a K252a derivative, retains neuroprotective properties
• CEP1347 25mg
CEP1347 25mg, a K252a derivative, retains neuroprotective properties
• CEP-1347 50mg
CEP-1347 50mg, a K252a derivative, retains neuroprotective properties

Other:
• Placebo Comparator
Placebo capsules matching the CEP-1347 capsules

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta - Glenrose Rehab Hospital	Edmonton	Alberta
Canada	University of Sherbrooke	Fleurimont	Quebec
Canada	London Health Sciences Center - University Campus	London	Ontario
Canada	Centre Hospitalier De L'Universite Montreal	Montreal	Quebec
Canada	Ottawa Hospital, Civic Site	Ottawa	Ontario
Canada	Saskatoon District Health Board - Royal University Hospital	Saskatoon	Saskatchewan
Canada	Toronto Hospital Western Division	Toronto	Ontario
Canada	McGill Center for Studies in Aging	Verdun	Quebec
Puerto Rico	University of Puerto Rico, Clinical Research Center	San Juan
United States	Parkinson's Disease & Movement Disorders Center of AMC	Albany	New York
United States	Medical College of Georgia	Augusta	Georgia
United States	Johns Hopkins University, Department of Neurology	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston University Medical Center, Department of Neurology	Boston	Massachusetts
United States	Brigham and Womens Hospital/Neurology	Boston	Massachusetts
United States	Center for Aging, Genetics and Neurodegeneration, Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia Health System/Adult Neurology	Charlottesville	Virginia
United States	Northwestern University, Department of Neurology	Chicago	Illinois
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Colorado Neurological Institute/Movement Disorders Center	Englewood	Colorado
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	The Parkinson's and Movement Disorders Institute	Fountain Valley	California
United States	Parkinson's Disease Center and Movement Disorders Clinic/Baylor College of Medicine	Houston	Texas
United States	Indiana University of Medicine/Outpatient Clinical Research Facility	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics, Department of Neurology	Iowa City	Iowa
United States	University of California Irvine	Irvine	California
United States	Davis Building - Neurology 8-B	Jacksonville	Florida
United States	University of Kansas Medical Center/Dept. of Neurology	Kansas City	Kansas
United States	University of Arkansas for Medical Services	Little Rock	Arkansas
United States	USC, Keck School of Pharmacy, Department of Neurology	Los Angeles	California
United States	Movement Disorders Center/North Shore - LIJ Health System	Manhasset	New York
United States	University of Tennessee Memphis, Semmes Murphy Clinic	Memphis	Tennessee
United States	Medical College of Wisconsin, Department Neurology	Milwaukee	Wisconsin
United States	University of Minnesota, Department of Neurology	Minneapolis	Minnesota
United States	UMDNJ Robert Wood Johnson Medical Center	New Brunswick	New Jersey
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Beth Israel Medical Center, Department of Neurology	New York	New York
United States	Columbia Presbyterian Medical Center, Neurological Institute	New York	New York
United States	Creighton University/Department of Neurology	Omaha	Nebraska
United States	California Medical Clinic for Movement Disorders	Oxnard	California
United States	Brown University/Memorial Hospital of Rhode Island/Neurology Dept.	Pawtucket	Rhode Island
United States	Pennsylvania Hospital/Dept. of Neurology	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Oregon Health Sciences University/Dept. of Neurology	Portland	Oregon
United States	University of Rochester, Department of Neurology	Rochester	New York
United States	Department of Neurology - UC Davis Medical Center	Sacramento	California
United States	University of California San Diego	San Diego	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	LSUHSC in Shreveport	Shreveport	Louisiana
United States	Clinical Neuroscience Center	Southfield	Michigan
United States	Washington University	St. Louis	Missouri
United States	Stanford University Medical Center, Dept. of Neurology	Stanford	California
United States	University of Medicine and Dentistry of New Jersey/Center for Aging	Stratford	New Jersey
United States	The Parkinson's Institute	Sunnyvale	California
United States	University of South Florida, Harbourside Medical Tower	Tampa	Florida
United States	Scott and White Clinic/Texas A & M University	Temple	Texas
United States	Medical College of Ohio, Department of Neurology	Toledo	Ohio
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Cephalon	H. Lundbeck A/S, The Parkinson Study Group

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with disability using United Parkinson's Disease Rating Scale (UPDRS)	Number of participants with disability sufficient to require dopaminergic therapy was assessed according to the United Parkinson's Disease Rating Scale (UPDRS) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.	48 months	No
Secondary	Change from Baseline to 22 months in ([123I]ß-CIT) Uptake Participants	The effect of CEP-1347 on dopaminergic transporter density using 2ß-carboxymethoxy-3ß-(4-iodophenyl) tropane ([123I]ß-CIT) single-photon emission computed tomography (SPECT) imaging	Change from Baseline to 22 months	No
Secondary	Safety and Tolerability as assessed by the number of participants experiencing adverse events	Safety was assessed by adverse events (including deaths, serious adverse events, and withdrawals due to adverse events.)	48 months	Yes

External Links

•   The Parkinson Study Group (PSG) is a non-profit, cooperative group of Parkinson's disease experts from medical centers in the United States and Canada who are dedicated to improving treatment for persons affected by Parkinson's disease.