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

Phase 2

Terminated

• Conditions: Parkinson Disease
• Interventions: Drug: CEP-1347 10mg; Drug: CEP-1347 50mg; Drug: CEP1347 25mg; Other: Placebo Comparator

• Registration Number: NCT00040404
• Lead Sponsor: Cephalon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2002-06-26
• Study First Submitted QC: 2002-06-26
• Study First Posted: 2002-06-27
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Status Verified: 2012-05
• Disposition First Submitted: 2012-05-03
• Disposition First Submitted QC: 2012-05-03
• Disposition First Posted: 2012-05-08
• Last Update Submitted: 2012-05-08
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 806

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CEP-1347 10mg	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.
CEP-1347 50mg	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.
CEP-1347 25mg	CEP1347 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.
Placebo	Placebo Comparator	Placebo capsules matching the CEP-1347 capsules were administered in the same manner.

Primary Outcome Measures

Name	Time	Method
Number of participants with disability using United Parkinson's Disease Rating Scale (UPDRS)	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

Name	Time	Method
Change from Baseline to 22 months in ([123I]β-CIT) Uptake Participants	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
Safety and Tolerability as assessed by the number of participants experiencing adverse events	48 months	Safety was assessed by adverse events (including deaths, serious adverse events, and withdrawals due to adverse events.)

Trial Locations

Locations (66)

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

University of Arkansas for Medical Services; 🇺🇸 Little Rock, Arkansas, United States

The Parkinson's and Movement Disorders Institute; 🇺🇸 Fountain Valley, California, United States

University of California Irvine; 🇺🇸 Irvine, California, United States

USC, Keck School of Pharmacy, Department of Neurology; 🇺🇸 Los Angeles, California, United States

California Medical Clinic for Movement Disorders; 🇺🇸 Oxnard, California, United States

Department of Neurology - UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

Stanford University Medical Center, Dept. of Neurology; 🇺🇸 Stanford, California, United States

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