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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00040404
Recruitment Status : Terminated (Unlikely to provide evidence of significant effect)
First Posted : June 27, 2002
Last Update Posted : May 10, 2012
Sponsor:
Collaborators:
H. Lundbeck A/S
The Parkinson Study Group
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc. ( Cephalon )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: CEP-1347 10mg Drug: CEP1347 25mg Drug: CEP-1347 50mg Other: Placebo Comparator Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 806 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2002
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.)


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00040404


Locations
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Sponsors and Collaborators
Cephalon
H. Lundbeck A/S
The Parkinson Study Group
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cephalon
ClinicalTrials.gov Identifier: NCT00040404    
Other Study ID Numbers: C1347c/204/PD/US-CA
First Posted: June 27, 2002    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: May 2012
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc. ( Cephalon ):
Parkinson's disease
Idiopathic Parkinson's disease
Idiopathic Parkinson disease
Parkinson's disease, idiopathic
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases