improvement of cognitive performance after administration of fampridina in patients with multiple sclerosis

Phase 1

Conditions: MULTIPLE SCLEROSIS
MedDRA version: 20.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2013-002558-64-IT

Lead Sponsor: dipartimento di neurologia e psichiatria

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 123

Inclusion Criteria

age from 18 to 65 years (inclusive);
a cognitive impairment as defined as a score less than 10 percentile in at least one of the test used in the neuropsychological evaluation at screening
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 123
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

clinical relapse occurred in the previous 60 days;
history of major depression or psychosis, according on Beck Depression Inventory-IA (cut-off 19);
history of seizures; any condition that would interfere with study conduction, introduction or modification of any medication for mood, fatigue or cognition in the previous month.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To analyze the effects of the drug on cognitive function in MS patients measured with Symbol Digit Modalities Test (SDMT). <br>;Secondary Objective: EVALUATION BY the Stroop test (ST)) ; the Tower of London (TOW), the PASAT, Selective Reminding Test (SRT), e 10/36 Spatial Recall Test . <br>Two questionnaires will be also administrated: the MSIS-29 to assess the physical and psychological impact of the disease on daily living, the FSMC for the assessment of physical, cognitive and psychosocial fatigue. The Beck Depression Inventory will be administrated to test depression .;Primary end point(s): To analyze the effects of the drug on speed of information processing measured with Symbol Digit Modalities Test (SDMT) <br>;Timepoint(s) of evaluation of this end point: 12 WEEKS

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 12 WEEKS;Secondary end point(s): EVALUATION BY the Stroop test (ST)) ; the Tower of London (TOW), the PASAT, Selective Reminding Test (SRT), e 10/36 Spatial Recall Test . <br>Two questionnaires will be also administrated: the MSIS-29 to assess the physical and psychological impact of the disease on daily living, the FSMC for the assessment of physical, cognitive and psychosocial fatigue. The Beck Depression Inventory will be administrated to test depression .