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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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28 September 2015 |
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Main ID: |
EUCTR2014-003498-41-AT |
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Date of registration:
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06/08/2015 |
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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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Effects of dalfampridine on mobility in the context of daily life
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Scientific title:
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Effects of dalfampridine on mobility in the context of daily life - Fampridine Study in Activities of Daily Living |
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Date of first enrolment:
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22/09/2015 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003498-41 |
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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: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Austria
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Contacts
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Name:
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Clinical trial information desk
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Address:
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Schönbrunnerstraße 108, Eingang Sterkgasse
1050
Vienna
Austria |
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Telephone:
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Email:
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post@wpa.wien.gv.at |
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Affiliation:
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Wiener Pflege, PatientInnen und Patientenanwaltschaft |
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Name:
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Clinical trial information desk
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Address:
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Schönbrunnerstraße 108, Eingang Sterkgasse
1050
Vienna
Austria |
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Telephone:
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Email:
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post@wpa.wien.gv.at |
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Affiliation:
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Wiener Pflege, PatientInnen und Patientenanwaltschaft |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients over 18 years with multiple sclerosis and an EDSS between 4 and 7, suffering from gait disturbance will be included. Only patients who have been identified as responders during a previous named patient programme and were refused to get reimbursement by the public health care system in Austria will be included.
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 51
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Exclusion criteria will be a treatment with Fampridine less then 6 weeks before the start of the study, previously identified non-response to Fampridine and an age below 18 years.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Motor behaviour and cognition in multiple sclerosis patients
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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Trade Name: Fampyra
Pharmaceutical Form: Tablet
INN or Proposed INN: FAMPRIDINE
CAS Number: 504-24-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
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Primary Outcome(s)
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Primary end point(s): Changes in gait mobility as assessed by GTX3+ accelerometers after 6 weeks
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Secondary Objective: Moreover, the influence of Fampridine-SR on MS-related chronic fatigue and cognition will be studied. In a subset of study participants we seek to provide objective proof-of-concept evidence by use of functional magnetic resonance imaging (fMRI) of potential central effects of dalfampridine on remodelling of sensorimotor and cognitive cerebral networks.
Further, by establishing fMRI correlates of behaviourally improved function, we wish to test whether fMRI could serve as a non-invasive functional biomarker in responders to this specific drug. The proposed approach would involve both assessments of changes in sensorimotor network activity (elicited by bipedal ankle-movements as a surrogate of the complex behaviour of gait) and in cognitive network activity (implicated in a response inhibition-disinhibition task).
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Main Objective: The aim of the study is to explore, if the use of Fampyra offers any meaningful improvement in the daily activity of patients as demanded from the public health care system in Austria.
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Timepoint(s) of evaluation of this end point: after 6 weeks
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Secondary Outcome(s)
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Secondary end point(s): Changes in basic and instrumental activities of daily life as assessed by the COPM and
MS specific Fatigue Scale and Fatigue Severity Scale
fMRI activity and connectivity changes
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Timepoint(s) of evaluation of this end point: Baesline vs. 6 weeks
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Source(s) of Monetary Support
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Biogen Idec
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Medical University of Vienna, Department of Neurology
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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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