Safety and Efficacy Study of CEP-1347 in the Treatment of... | NCT00040404

Status Module

Name	Class
H. Lundbeck A/S	INDUSTRY
The Parkinson Study Group	NETWORK

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CEP-1347 10mg	Experimental	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 25mg	Experimental	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
CEP-1347 50mg	Experimental	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
Placebo

Name	Type	Description	Arm Group Labels	Other Names
CEP-1347 10mg	Drug	CEP-1347 10mg, a K252a derivative, retains neuroprotective properties	CEP-1347 10mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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	Change from Baseline to 22 months
Safety and Tolerability as assessed by the number of participants experiencing adverse events

Eligibility Module

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	Status	City	State	ZIP	Country	Contacts
Barrow Neurological Institute		Phoenix	Arizona	85013	United States
Mayo Clinic Arizona

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18413464	Derived	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.
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ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases