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Main
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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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16 September 2013 |
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Main ID: |
EUCTR2006-002856-14-DE |
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Date of registration:
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07/11/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Randomised, placebo-controlled, three-arm parallel-group, double-blind, multicentre, national clinical phase II study to evaluate the efficacy, safety, and tolerability of intravenous 3 and 6 g/m² treosulfan given every 6 weeks in patients with secondary progressive and progressive relapsing multiple sclerosis.
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Scientific title:
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Randomised, placebo-controlled, three-arm parallel-group, double-blind, multicentre, national clinical phase II study to evaluate the efficacy, safety, and tolerability of intravenous 3 and 6 g/m² treosulfan given every 6 weeks in patients with secondary progressive and progressive relapsing multiple sclerosis. |
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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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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002856-14 |
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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:
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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Germany
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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) yes
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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Secondary progressive or progressive relapsing multiple sclerosis with
signs of disease activity in terms of inflammation
MedDRA version: 8.1
Level: LLT
Classification code 10063400
Term: Secondary progressive multiple sclerosis
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Intervention(s)
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Trade Name: Ovastat 1000
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: TREOSULFAN
CAS Number: 299752
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Ovastat 5000
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: TREOSULFAN
CAS Number: 299752
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5000-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Secondary Objective:
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Main Objective:
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Primary end point(s):
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Secondary ID(s)
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MC-T.10/MS
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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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