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Parkinson DiseasePhase 2/3NCT00040404

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

A Phase 2/3 study testing CEP-1347 10mg, CEP1347 25mg and CEP-1347 50mg in people with Parkinson Disease, run by Cephalon at 66 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
CEP-1347 10mg, CEP1347 25mg and CEP-1347 50mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
806 participants
Where
66 sitesin 3 countries
Study dates
Mar 2002to Aug 2005
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

66 sites in 3 countries.

66 sites in 3 countries

United States56 sites

  • Parkinson's Disease & Movement Disorders Center of AMC

    Albany, New York, 12205

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins University, Department of Neurology

    Baltimore, Maryland, 21287

  • Center for Aging, Genetics and Neurodegeneration, Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Womens Hospital/Neurology

    Boston, Massachusetts, 02115

  • Boston University Medical Center, Department of Neurology

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of Virginia Health System/Adult Neurology

    Charlottesville, Virginia, 22903

  • Northwestern University, Department of Neurology

    Chicago, Illinois, 60611

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0525

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • University of Colorado Health Sciences Center

    Denver, Colorado, 80262

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Colorado Neurological Institute/Movement Disorders Center

    Englewood, Colorado, 80110

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

  • The Parkinson's and Movement Disorders Institute

    Fountain Valley, California, 92708

  • Parkinson's Disease Center and Movement Disorders Clinic/Baylor College of Medicine

    Houston, Texas, 77030

  • Indiana University of Medicine/Outpatient Clinical Research Facility

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals and Clinics, Department of Neurology

    Iowa City, Iowa, 52242

  • University of California Irvine

    Irvine, California, 92697-4275

  • Davis Building - Neurology 8-B

    Jacksonville, Florida, 32224

  • University of Kansas Medical Center/Dept. of Neurology

    Kansas City, Kansas, 66160

  • University of Arkansas for Medical Services

    Little Rock, Arkansas, 72205

  • USC, Keck School of Pharmacy, Department of Neurology

    Los Angeles, California, 90033-0046

  • Movement Disorders Center/North Shore - LIJ Health System

    Manhasset, New York, 11030

  • University of Tennessee Memphis, Semmes Murphy Clinic

    Memphis, Tennessee, 38104

  • Medical College of Wisconsin, Department Neurology

    Milwaukee, Wisconsin, 53226

  • University of Minnesota, Department of Neurology

    Minneapolis, Minnesota, 55455

  • UMDNJ Robert Wood Johnson Medical Center

    New Brunswick, New Jersey, 08901

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Beth Israel Medical Center, Department of Neurology

    New York, New York, 10003

  • Columbia Presbyterian Medical Center, Neurological Institute

    New York, New York, 10032

  • Creighton University/Department of Neurology

    Omaha, Nebraska, 68131

  • California Medical Clinic for Movement Disorders

    Oxnard, California, 93030

  • Brown University/Memorial Hospital of Rhode Island/Neurology Dept.

    Pawtucket, Rhode Island, 02860

  • Pennsylvania Hospital/Dept. of Neurology

    Philadelphia, Pennsylvania, 19107

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Oregon Health Sciences University/Dept. of Neurology

    Portland, Oregon, 97201-3098

  • University of Rochester, Department of Neurology

    Rochester, New York, 14642

  • Department of Neurology - UC Davis Medical Center

    Sacramento, California, 95817

  • University of California San Diego

    San Diego, California, 92161

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • LSUHSC in Shreveport

    Shreveport, Louisiana, 71130

  • Clinical Neuroscience Center

    Southfield, Michigan, 48034

  • Washington University

    St Louis, Missouri, 63110

  • Stanford University Medical Center, Dept. of Neurology

    Stanford, California, 94305

  • University of Medicine and Dentistry of New Jersey/Center for Aging

    Stratford, New Jersey, 08084

  • The Parkinson's Institute

    Sunnyvale, California, 94089

  • University of South Florida, Harbourside Medical Tower

    Tampa, Florida, 33606

  • Scott and White Clinic/Texas A & M University

    Temple, Texas, 76508

  • Medical College of Ohio, Department of Neurology

    Toledo, Ohio, 43614

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

Canada9 sites

  • University of Calgary

    Calgary, Alberta, T2N 2N1

  • University of Alberta - Glenrose Rehab Hospital

    Edmonton, Alberta, T5G 0B7

  • University of Sherbrooke

    Fleurimont, Quebec, J1H 5N4

  • London Health Sciences Center - University Campus

    London, Ontario, N6A 5A5

  • Centre Hospitalier De L'Universite Montreal

    Montreal, Quebec, H2W 1T8

  • Ottawa Hospital, Civic Site

    Ottawa, Ontario, K1Y 4E9

  • Saskatoon District Health Board - Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Toronto Hospital Western Division

    Toronto, Ontario, M5T 2S8

  • McGill Center for Studies in Aging

    Verdun, Quebec, H4H 1R3

Other trials in Canada

Puerto Rico1 site

  • University of Puerto Rico, Clinical Research Center

    San Juan, 00901

Other trials in Puerto Rico

About this study

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

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.

Being tested
CEP-1347 10mg, CEP1347 25mg, CEP-1347 50mg, Placebo Comparator
Keywords
Parkinson's disease, Idiopathic Parkinson's disease, Idiopathic Parkinson disease, Parkinson's disease, idiopathic
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CEP-1347 10mgDrug

    CEP-1347 10mg, a K252a derivative, retains neuroprotective properties

  • CEP1347 25mgDrug

    CEP1347 25mg, a K252a derivative, retains neuroprotective properties

  • CEP-1347 50mgDrug

    CEP-1347 50mg, a K252a derivative, retains neuroprotective properties

  • Placebo ComparatorOther

    Placebo capsules matching the CEP-1347 capsules

Study groups in NCT00040404
Study groupRoleWhat they receive
CEP-1347 10mgExperimentalCEP-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.
Receives: Drug: CEP-1347 10mg
CEP-1347 25mgExperimentalCEP-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.
Receives: Drug: CEP1347 25mg
CEP-1347 50mgExperimentalCEP-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.
Receives: Drug: CEP-1347 50mg
PlaceboPlacebo comparatorPlacebo capsules matching the CEP-1347 capsules were administered in the same manner.
Receives: Other: Placebo Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 48 months

Secondary outcomes (2)

  1. 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

    Measured: Change from Baseline to 22 months

  2. 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.)

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2002 (estimated)
  2. Study startMar 2002
  3. Primary completionAug 2005
  4. Study completionAug 2005

Why it stopped: Unlikely to provide evidence of significant effect

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
806 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00040404
Sponsor's protocol ID
C1347c/204/PD/US-CA
Status last verified
May 2012
First submitted
26 Jun 2002
Last updated
10 May 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18413464

  • 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.

    PubMed 17881719

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CEP-1347 10mg, CEP1347 25mg and CEP-1347 50mg in people with Parkinson Disease, run by Cephalon at 66 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Unlikely to provide evidence of significant effect). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with disability using United Parkinson's Disease Rating Scale (UPDRS) (time frame: 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00040404, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2012.

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Clinical Trial NCT00040404 | AzTrials