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

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CEP-1347 10mg
CEP1347 25mg
CEP-1347 50mg
Placebo Comparator
Sponsored by
Cephalon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Idiopathic Parkinson's disease, Idiopathic Parkinson disease, Parkinson's disease, idiopathic

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barrow Neurological Institute
  • Mayo Clinic Arizona
  • University of Arkansas for Medical Services
  • The Parkinson's and Movement Disorders Institute
  • University of California Irvine
  • USC, Keck School of Pharmacy, Department of Neurology
  • California Medical Clinic for Movement Disorders
  • Department of Neurology - UC Davis Medical Center
  • University of California San Diego
  • Stanford University Medical Center, Dept. of Neurology
  • The Parkinson's Institute
  • University of Colorado Health Sciences Center
  • Colorado Neurological Institute/Movement Disorders Center
  • University of Connecticut Health Center
  • Institute for Neurodegenerative Disorders
  • Davis Building - Neurology 8-B
  • University of South Florida, Harbourside Medical Tower
  • Cleveland Clinic Florida
  • Medical College of Georgia
  • Northwestern University, Department of Neurology
  • Rush-Presbyterian-St. Luke's Medical Center
  • University of Chicago
  • Indiana University of Medicine/Outpatient Clinical Research Facility
  • University of Iowa Hospitals and Clinics, Department of Neurology
  • University of Kansas Medical Center/Dept. of Neurology
  • LSUHSC in Shreveport
  • University of Maryland
  • Johns Hopkins University, Department of Neurology
  • Center for Aging, Genetics and Neurodegeneration, Massachusetts General Hospital
  • Brigham and Womens Hospital/Neurology
  • Boston University Medical Center, Department of Neurology
  • Beth Israel Deaconess Medical Center
  • Clinical Neuroscience Center
  • University of Minnesota, Department of Neurology
  • Washington University
  • Creighton University/Department of Neurology
  • UMDNJ Robert Wood Johnson Medical Center
  • University of Medicine and Dentistry of New Jersey/Center for Aging
  • Parkinson's Disease & Movement Disorders Center of AMC
  • Movement Disorders Center/North Shore - LIJ Health System
  • Long Island Jewish Medical Center
  • Beth Israel Medical Center, Department of Neurology
  • Columbia Presbyterian Medical Center, Neurological Institute
  • University of Rochester, Department of Neurology
  • Duke University Medical Center
  • University of Cincinnati
  • Cleveland Clinic Foundation
  • Medical College of Ohio, Department of Neurology
  • Oregon Health Sciences University/Dept. of Neurology
  • Pennsylvania Hospital/Dept. of Neurology
  • Brown University/Memorial Hospital of Rhode Island/Neurology Dept.
  • University of Tennessee Memphis, Semmes Murphy Clinic
  • Parkinson's Disease Center and Movement Disorders Clinic/Baylor College of Medicine
  • Scott and White Clinic/Texas A & M University
  • University of Virginia Health System/Adult Neurology
  • Medical College of Wisconsin, Department Neurology
  • University of Calgary
  • University of Alberta - Glenrose Rehab Hospital
  • London Health Sciences Center - University Campus
  • Ottawa Hospital, Civic Site
  • Toronto Hospital Western Division
  • University of Sherbrooke
  • Centre Hospitalier De L'Universite Montreal
  • McGill Center for Studies in Aging
  • Saskatoon District Health Board - Royal University Hospital
  • University of Puerto Rico, Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

CEP-1347 10mg

CEP-1347 25mg

CEP-1347 50mg

Placebo

Arm Description

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.

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.

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.

Placebo capsules matching the CEP-1347 capsules were administered in the same manner.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from Baseline to 22 months in ([123I]β-CIT) Uptake Participants
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
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.)

Full Information

First Posted
June 26, 2002
Last Updated
May 8, 2012
Sponsor
Cephalon
Collaborators
H. Lundbeck A/S, The Parkinson Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00040404
Brief Title
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

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Unlikely to provide evidence of significant effect
Study Start Date
March 2002 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cephalon
Collaborators
H. Lundbeck A/S, The Parkinson Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Idiopathic Parkinson's disease, Idiopathic Parkinson disease, Parkinson's disease, idiopathic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
806 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CEP-1347 10mg
Arm Type
Experimental
Arm Description
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.
Arm Title
CEP-1347 25mg
Arm Type
Experimental
Arm Description
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.
Arm Title
CEP-1347 50mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules matching the CEP-1347 capsules were administered in the same manner.
Intervention Type
Drug
Intervention Name(s)
CEP-1347 10mg
Intervention Description
CEP-1347 10mg, a K252a derivative, retains neuroprotective properties
Intervention Type
Drug
Intervention Name(s)
CEP1347 25mg
Intervention Description
CEP1347 25mg, a K252a derivative, retains neuroprotective properties
Intervention Type
Drug
Intervention Name(s)
CEP-1347 50mg
Intervention Description
CEP-1347 50mg, a K252a derivative, retains neuroprotective properties
Intervention Type
Other
Intervention Name(s)
Placebo Comparator
Intervention Description
Placebo capsules matching the CEP-1347 capsules
Primary Outcome Measure Information:
Title
Number of participants with disability using United Parkinson's Disease Rating Scale (UPDRS)
Description
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.
Time Frame
48 months
Secondary Outcome Measure Information:
Title
Change from Baseline to 22 months in ([123I]β-CIT) Uptake Participants
Description
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
Time Frame
Change from Baseline to 22 months
Title
Safety and Tolerability as assessed by the number of participants experiencing adverse events
Description
Safety was assessed by adverse events (including deaths, serious adverse events, and withdrawals due to adverse events.)
Time Frame
48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of Arkansas for Medical Services
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
The Parkinson's and Movement Disorders Institute
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697-4275
Country
United States
Facility Name
USC, Keck School of Pharmacy, Department of Neurology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0046
Country
United States
Facility Name
California Medical Clinic for Movement Disorders
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Department of Neurology - UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Stanford University Medical Center, Dept. of Neurology
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
The Parkinson's Institute
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94089
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Colorado Neurological Institute/Movement Disorders Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Davis Building - Neurology 8-B
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of South Florida, Harbourside Medical Tower
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwestern University, Department of Neurology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush-Presbyterian-St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University of Medicine/Outpatient Clinical Research Facility
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospitals and Clinics, Department of Neurology
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center/Dept. of Neurology
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
LSUHSC in Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University, Department of Neurology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Center for Aging, Genetics and Neurodegeneration, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Womens Hospital/Neurology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University Medical Center, Department of Neurology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Clinical Neuroscience Center
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
University of Minnesota, Department of Neurology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Creighton University/Department of Neurology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
UMDNJ Robert Wood Johnson Medical Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey/Center for Aging
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
Parkinson's Disease & Movement Disorders Center of AMC
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Movement Disorders Center/North Shore - LIJ Health System
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Beth Israel Medical Center, Department of Neurology
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Columbia Presbyterian Medical Center, Neurological Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester, Department of Neurology
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0525
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Medical College of Ohio, Department of Neurology
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Oregon Health Sciences University/Dept. of Neurology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Pennsylvania Hospital/Dept. of Neurology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Brown University/Memorial Hospital of Rhode Island/Neurology Dept.
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
University of Tennessee Memphis, Semmes Murphy Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Parkinson's Disease Center and Movement Disorders Clinic/Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott and White Clinic/Texas A & M University
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
University of Virginia Health System/Adult Neurology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Medical College of Wisconsin, Department Neurology
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2N1
Country
Canada
Facility Name
University of Alberta - Glenrose Rehab Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B7
Country
Canada
Facility Name
London Health Sciences Center - University Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Ottawa Hospital, Civic Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Toronto Hospital Western Division
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
University of Sherbrooke
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Centre Hospitalier De L'Universite Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
McGill Center for Studies in Aging
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Facility Name
Saskatoon District Health Board - Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
University of Puerto Rico, Clinical Research Center
City
San Juan
ZIP/Postal Code
00901
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
18413464
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.
Results Reference
derived
PubMed Identifier
17881719
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.
Results Reference
derived
Links:
URL
http://parkinson-study-group.org
Description
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.

Learn more about this trial

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

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