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

May 8, 2012 updated by: Cephalon

A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 in Patients With Parkinson's Disease

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

806

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2N1
        • University of Calgary
      • Edmonton, Alberta, Canada, T5G 0B7
        • University of Alberta - Glenrose Rehab Hospital
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Center - University Campus
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital, Civic Site
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Hospital Western Division
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • University of Sherbrooke
      • Montreal, Quebec, Canada, H2W 1T8
        • Centre Hospitalier De L'Universite Montreal
      • Verdun, Quebec, Canada, H4H 1R3
        • McGill Center for Studies in Aging
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Saskatoon District Health Board - Royal University Hospital
  • Puerto Rico
      • San Juan, Puerto Rico, 00901
        • University of Puerto Rico, Clinical Research Center
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University Of Arkansas For Medical Services
    • California
      • Fountain Valley, California, United States, 92708
        • The Parkinson's and Movement Disorders Institute
      • Irvine, California, United States, 92697-4275
        • University of California Irvine
      • Los Angeles, California, United States, 90033-0046
        • USC, Keck School of Pharmacy, Department of Neurology
      • Oxnard, California, United States, 93030
        • California Medical Clinic for Movement Disorders
      • Sacramento, California, United States, 95817
        • Department of Neurology - UC Davis Medical Center
      • San Diego, California, United States, 92161
        • University of California San Diego
      • Stanford, California, United States, 94305
        • Stanford University Medical Center, Dept. of Neurology
      • Sunnyvale, California, United States, 94089
        • The Parkinson's Institute
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Health Sciences Center
      • Englewood, Colorado, United States, 80110
        • Colorado Neurological Institute/Movement Disorders Center
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health Center
      • New Haven, Connecticut, United States, 06510
        • Institute for Neurodegenerative Disorders
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Davis Building - Neurology 8-B
      • Tampa, Florida, United States, 33606
        • University of South Florida, Harbourside Medical Tower
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Department of Neurology
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University of Medicine/Outpatient Clinical Research Facility
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics, Department of Neurology
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center/Dept. of Neurology
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
        • LSUHSC in Shreveport
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University, Department of Neurology
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Center for Aging, Genetics and Neurodegeneration, Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Brigham and Womens Hospital/Neurology
      • Boston, Massachusetts, United States, 02118
        • Boston University Medical Center, Department of Neurology
    • Michigan
      • Southfield, Michigan, United States, 48034
        • Clinical Neuroscience Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota, Department of Neurology
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University/Department of Neurology
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • UMDNJ Robert Wood Johnson Medical Center
      • Stratford, New Jersey, United States, 08084
        • University of Medicine and Dentistry of New Jersey/Center for Aging
    • New York
      • Albany, New York, United States, 12205
        • Parkinson's Disease & Movement Disorders Center of AMC
      • Manhasset, New York, United States, 11030
        • Movement Disorders Center/North Shore - LIJ Health System
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10003
        • Beth Israel Medical Center, Department of Neurology
      • New York, New York, United States, 10032
        • Columbia Presbyterian Medical Center, Neurological Institute
      • Rochester, New York, United States, 14642
        • University of Rochester, Department of Neurology
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0525
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Toledo, Ohio, United States, 43614
        • Medical College of Ohio, Department of Neurology
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Oregon Health Sciences University/Dept. of Neurology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hospital/Dept. of Neurology
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Brown University/Memorial Hospital of Rhode Island/Neurology Dept.
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • University of Tennessee Memphis, Semmes Murphy Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • Parkinson's Disease Center and Movement Disorders Clinic/Baylor College of Medicine
      • Temple, Texas, United States, 76508
        • Scott and White Clinic/Texas A & M University
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System/Adult Neurology
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin, Department Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CEP-1347 10mg
CEP-1347 was administered at a dosage of 10mg twice daily (bid); capsule strengths were 5, 12.5, and 25 mg. Each patient took 2 capsules at each dosing time, approximately 12 hours apart, within 30 minutes after the morning and evening meals) for a total of 4 capsules per day.Patients were randomly assigned to CEP-1347 or placebo treatment in a 1:1:1:1 ratio. A blocked randomization scheme was used to ensure approximately equal numbers of patients in each of the 4 treatment groups at each center.
Drug: CEP-1347 10mg
CEP-1347 10mg, a K252a derivative, retains neuroprotective properties
Experimental: CEP-1347 25mg
CEP-1347 was administered at a dosage of 25mg twice daily (bid); capsule strengths were 5, 12.5, and 25 mg. Each patient took 2 capsules at each dosing time, approximately 12 hours apart, within 30 minutes after the morning and evening meals) for a total of 4 capsules per day.Patients were randomly assigned to CEP-1347 or placebo treatment in a 1:1:1:1 ratio. A blocked randomization scheme was used to ensure approximately equal numbers of patients in each of the 4 treatment groups at each center.
Drug: CEP1347 25mg
CEP1347 25mg, a K252a derivative, retains neuroprotective properties
Experimental: CEP-1347 50mg
CEP-1347 was administered at a dosage of 50mg twice daily (bid); capsule strengths were 5, 12.5, and 25 mg. Each patient took 2 capsules at each dosing time, approximately 12 hours apart, within 30 minutes after the morning and evening meals) for a total of 4 capsules per day.Patients were randomly assigned to CEP-1347 or placebo treatment in a 1:1:1:1 ratio. A blocked randomization scheme was used to ensure approximately equal numbers of patients in each of the 4 treatment groups at each center.
Drug: CEP-1347 50mg
CEP-1347 50mg, a K252a derivative, retains neuroprotective properties
Placebo Comparator: Placebo
Placebo capsules matching the CEP-1347 capsules were administered in the same manner.
Other: Placebo Comparator
Placebo capsules matching the CEP-1347 capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with disability using United Parkinson's Disease Rating Scale (UPDRS)
Time Frame: 48 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to 22 months in ([123I]β-CIT) Uptake Participants
Time Frame: Change from Baseline to 22 months
The effect of CEP-1347 on dopaminergic transporter density using 2β-carboxymethoxy-3β-(4-iodophenyl) tropane ([123I]β-CIT) single-photon emission computed tomography (SPECT) imaging
Change from Baseline to 22 months
Safety and Tolerability as assessed by the number of participants experiencing adverse events
Time Frame: 48 months
Safety was assessed by adverse events (including deaths, serious adverse events, and withdrawals due to adverse events.)
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cephalon

Collaborators

H. Lundbeck A/S
The Parkinson Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

June 26, 2002

First Submitted That Met QC Criteria

June 26, 2002

First Posted (Estimate)

June 27, 2002

Study Record Updates

Last Update Posted (Estimate)

May 10, 2012

Last Update Submitted That Met QC Criteria

May 8, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1347c/204/PD/US-CA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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