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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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7 September 2021 |
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Main ID: |
EUCTR2006-005262-39-DE |
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Date of registration:
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09/03/2007 |
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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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Flupirtin as Oral Treatment in MS - FLORIMS
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Scientific title:
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Flupirtin as Oral Treatment in MS - FLORIMS |
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Date of first enrolment:
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30/05/2007 |
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Target sample size:
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80 |
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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:2006-005262-39 |
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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: no
Placebo: yes
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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Germany
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
written informed consent, age 18-55 yrs. at randomization, RR-MS according to revised McDonald criteria (2005), EDSS 6 months, in women reliable contraception (Pearl index <1), negative pregnancy test at inclusion
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:
all other forms of MS apart from RR-MS, any other illness that could explain symptoms better than RR-MS, any condition preventing/ disturbing cMRI or other examinations, relevant gastrointestinal, pulmonary, infectious, heart or CNS disease, relevant liver disease, cholestasis, elevated liver enzymes and bilirubin, bone marrow dysfunction, renal dysfunction, myasthenia gravis, allergy against gadolinium-DTPA, flupirtin maleat or additives, treatment with drugs toxic to liver, anticoagulants, carbamazepine or paracetamol, alcohol or drug abuse, pregnancy, lactation
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Relapsing-remitting multiple sclerosis
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Intervention(s)
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Trade Name: Trancopal Dolo
Product Name: Flupirtin
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Flupirtin
CAS Number: 56995-20-1
Other descriptive name: Flupirtinmaleat
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: Assessment of efficacy and safety of flupirtin compared to placebo as an add-on to treatment with IFN-beta in RR-MS. Primary objectives are the incidence of new T2-lesions, the number of patients without newly occurring T2 lesions over the treatmant period, "lesion load", number and volume of "black holes", "brain parenchymal fraction" measured by cerebral MRI and changes in the relation of NAA and choline measured by MRS.
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Primary end point(s): Primary objectives are the incidence of new T2-lesions, the number of patients without newly occurring T2 lesions over the treatmant period, "lesion load", number and volume of "black holes", "brain parenchymal fraction" measured by cerebral MRI and changes in the relation of NAA and choline measured by MRS.
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Secondary Objective: Secondary objectives are the annualized number of relapses over 12 months of flupirtin treatment compared to 12 months prior to treatment, the number of patients without relapse, progression of disability, parameters of neuronal atrophy, cognitive/ neuropsychological parameters and the effects of flupirtin on peripheral mononuclear blood cells compared to placebo.
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Secondary ID(s)
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2006-2209
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 24/01/2007
Contact:
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