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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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19 March 2012 |
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Main ID: |
EUCTR2004-000759-40-IT |
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Date of registration:
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15/02/2005 |
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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 pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 15 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis.
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Scientific title:
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A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 15 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. |
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Date of first enrolment:
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22/10/2004 |
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Target sample size:
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25 |
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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:2004-000759-40 |
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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: no
Open: yes
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
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) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Subject with relapsing remitting Multiple Sclerosis. Subject must have at least one documented relapse within one year prior to screening visit.
MedDRA version: 6.1
Level: PT
Classification code 10028245
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Intervention(s)
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Product Name: glatiramer acetate
Product Code: TV-5010
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Glatiramer acetate
Current Sponsor code: TV - 5010
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
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Primary Outcome(s)
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Main Objective:
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Primary end point(s):
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Secondary Objective:
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Secondary ID(s)
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TV - 5010/201
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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