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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2005-001476-13-GB |
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Date of registration:
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14/12/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, LONG-TERM EXTENSION STUDY TO DETERMINE THE SAFETY, TOLERABILITY, AND PRELIMINARY LONG TERM EFFICACY OF LECOZOTAN (SRA-333) SR IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE - N/A
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Scientific title:
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A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, LONG-TERM EXTENSION STUDY TO DETERMINE THE SAFETY, TOLERABILITY, AND PRELIMINARY LONG TERM EFFICACY OF LECOZOTAN (SRA-333) SR IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE - N/A |
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Date of first enrolment:
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21/02/2007 |
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Target sample size:
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250 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001476-13 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Finland
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France
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Italy
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Patient has completed Week 12 evaluations of study 3098B1-201-EU [EudraCT No. 001475-35] (no early completions) and been compliant.
2. Patient has MMSE =12 and, in the judgment of the investigator, there has been no clinically significant cognitive deterioration since enrollment in study 3098B1-201-EU.
3. 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.
4. Able to participate in all scheduled evaluations and complete all required tests.
5. In the opinion of the investigator, the patient and caregiver will be compliant and have a high probability of completing the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Any clinically significant abnormality in physical examination, vital signs, adverse events, electrocardiogram (ECG) or clinical laboratory test results, observed at the baseline visit (week 12 of the double-blind active phase of study 3098B1-201-EU), that, in the judgment of the investigator, is likely to deteriorate or affect the patient’s safety or ability to complete the study.
2. Use of medications for cognitive enhancement, including memantine, cholinesterase inhibitors, or other prohibited medications as per protocol 3098B1-201-EU [EudraCT No. 2005-001475-35].
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Alzheimer's Disease
MedDRA version: 8.1
Level: LLT
Classification code 10001896
Term: Alzheimer's disease
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Intervention(s)
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Product Name: Lecozotan SR
Product Code: SRA-333 SR
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Lecozotan
CAS Number: 433282-68-9
Current Sponsor code: SRA-333
Other descriptive name: WAY-161333 HCl
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Modified-release tablet
Route of administration of the placebo: Oral use
Product Name: Lecozotan SR
Product Code: SRA-333 SR
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Lecozotan
CAS Number: 433282-68-9
Current Sponsor code: SRA-333
Other descriptive name: WAY-161333 HCl
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Modified-release tablet
Route of administration of the placebo: Oral use
Trade Name: Aricept
Product Name: Aricept (over encapsulated and powder filled)
Pharmaceutical Form: Tablet
INN or Proposed INN: Donepezil Hydrochloride
CAS Number: 120011-70-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: Primary:
To evaluate the safety and tolerability of long-term therapy with three dose levels (2, 5, 10 mg daily) of Lecozotan (SRA-333) SR administered to patients with mild to moderate Alzheimer’s Disease who have completed Week 12 evaluations of study 3098B1-201-EU [EudraCT No. 2005-001475-35].
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Primary end point(s): The primary objective of the study is to assess the safety and tolerability of long-term therapy with lecozotan SR. Listings and summary tabulations of adverse events and treatment-emergent adverse events (TEAEs) will be generated. Adverse events will be classified by body system and preferred term. Summaries of the number of patients with events will be provided by each treatment group.
A secondary objective of the study is to assess the preliminary efficacy of long-term treatment with lecozotan SR. The mean changes from study 3098B1-201 baseline in ADAS-Cog total, the composite z-score of CDT-CAT, the behavioral NPI total, the functional DAD total, the Cornell total score and the global ADCS-CGIC score will be computed with their 95% confidence intervals for each visit by treatment group.
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Secondary Objective: To evaluate the preliminary efficacy of long-term treatment with Lecozotan SR and to measure quality of life in patients with mild to moderate Alzheimer’s Disease and effort levels of care providers.
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Secondary ID(s)
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2005-001476-13-FI
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3098B1-202
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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