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    The EU Clinical Trials Register currently displays   39231   clinical trials with a EudraCT protocol, of which   6427   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-001475-35
    Sponsor's Protocol Code Number:3098B1-201
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-05
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2005-001475-35
    A.3Full title of the trial
    A 3-MONTH, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED,
    MULTICENTER, SAFETY, TOLERABILITY, AND EFFICACY STUDY OF 3 DOSES OF LECOZOTAN (SRA-333) SR IN OUTPATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE WITH DONEPEZIL AS ACTIVE CONTROL
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code number3098B1-201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLecozotan SR
    D.3.2Product code SRA-333 SR
    D.3.4Pharmaceutical form Modified-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLecozotan
    D.3.9.1CAS number 433282-68-9
    D.3.9.2Current sponsor codeSRA-333
    D.3.9.3Other descriptive nameWAY-161333 HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLecozotan SR
    D.3.2Product code SRA-333 SR
    D.3.4Pharmaceutical form Modified-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLecozotan
    D.3.9.1CAS number 433282-68-9
    D.3.9.2Current sponsor codeSRA-333
    D.3.9.3Other descriptive nameWAY-161333 HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Aricept
    D.2.1.1.2Name of the Marketing Authorisation holderEisai-Pfizer
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAricept [encapsulated and powder filled]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdonepezil hydrochloride
    D.3.9.1CAS number 120011-70-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboModified-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the safety, tolerability, and efficacy of 3 doses of Lecozotan (SRA-333) SR (2 mg, 5 mg and 10 mg) in patients with mild to moderate Alzheimer's Disease (AD).
    E.2.2Secondary objectives of the trial
    Secondary objectives are to estimate comparative safety, tolerability and efficacy versus donepezil over a 12-week period in patients with AD and to measure the responsiveness of patient and caregiver-reported outcomes instruments.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
    2. Men and postmenopausal or surgically sterile women aged 50 years or older. Postmenopausal women must have had at least 12 months of spontaneous amenorrhea. Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy (oophorectomy), or bilateral tubal ligation.
    3. Mini-Mental State Examination (MMSE) score of 12 to 26.
    4. Rosen Modified Hachinski Ischemic score =< 4.
    5. Lives at home with appropriate caregiver, or community dwelling with caregiver capable of accompanying patient on all clinic visits and visiting the patient at least daily for the duration of the study.
    6. Computed tomography (CT) or magnetic resonance imaging (MRI) scan within the past 2 years (performed after onset of dementia) consistent with the diagnosis of AD. There should be no clinical evidence of stroke since completion of the imaging study (one lacuna, in areas not related to cognitive function, eg, cerebellum or deep white matter, will not exclude the patient).
    7. Able to give signed and dated written informed consent in accordance with local regulations. The patient’s caregiver will also consent to participate in the study.
    8. Able to complete all required neuropsychological tests.
    9. Fluency in local language.
    10. Receiving stable doses of medications for the treatment of nonexcluded medical conditions for 30 days before screening.
    11. Able to participate in all scheduled evaluations and complete all required tests.
    12. In the opinion of the investigator, the patient and caregiver will be compliant and have a high probability of completing the study.
    E.4Principal exclusion criteria
    1. Significant neurological disease other than AD that may affect cognition (eg, epilepsy, Parkinson disease) or ability to complete the study.
    2. Current diagnosis of a major depressive disorder or other major psychiatric symptoms included in psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision (DSM IV-TR), criteria.
    3. Current clinically significant systemic illness that, in the judgment of the investigator, is likely to deteriorate or affect the patient’s safety, influence cognitive assessment, or ability to complete the study.
    4. History of seizure, except febrile childhood febrile seizures.
    5. History of clinically evident stroke or clinically significant carotid or vertebrobasilar stenosis or plaque.
    6. Myocardial infarction within the last 3 months.
    7. History of cancer within the last 5 years, with the exception of nonmetastatic basal and/or squamous cell carcinoma of the skin
    8. Excessive smoking (greater than 20 cigarettes a day).
    9. History of alcohol or drug dependence within the last 1 year.
    10. Hamilton Psychiatric Rating Scale for Depression, 21 items (HAM-D21) score > 17.
    11. Any clinically significant abnormality in physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that in the judgment of the investigator, is likely to deteriorate or affect the patient’s safety or ability to complete the study.
    12. History of any clinically important multiple drug allergies, that will compromise the patient’s safety during the study.
    13. Use of prescription or nonprescription medications for medications for cognitive enhancement, (including memantine, and the use of cholinesterase inhibitors) within 3 months of the baseline visit. History of clinically significant side effects attributable to cholinesterase inhibitors and any history of intolerance, or lack of response to cholinesterase inhibitors.
    14. Any use of experimental drugs investigational drugs or procedures, including experimental medications for AD, within 30 days of baseline visit.
    15. Current use of anticonvulsant, anti Parkinson, antipsychotic, antidepressant medication and buspirone within 30 days of baseline visit (except for fluoxetine, which is excluded within 60 days of baseline).
    16. Regular use of narcotic medications within 30 days of baseline visit.
    17. Treatment with strong inhibitors of the cytochrome P450 3A4 isoenzyme system (i.e. ketoconazole, itraconazole, erythromycin, clarithromycin) within 1 week of baseline visit.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints will be the change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) total score and Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at week 12.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Health Outcomes Assessments
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last subject:
    Patients who complete Week 12 evaluations and meet the eligibility criteria at baseline visit, will be offered continued treatment in a long-term extension study (Protocol 3098B1-202).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 355
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients who complete Week 12 evaluations and meet the eligibility criteria at baseline visit, will be offered continued treatment in the long-term extension study (3098B1-202). Patients will stay in the same treatment group, except the placebo patients who will be re-randomized to 1 of the 3 Lecozotan SR arms. Patients who do not transition to the extension study will continue to be followed by the investigator who will discuss with them the available treatments for Alzheimer's disease.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-06-01
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