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

A randomised, placebo-controlled trial investigating the role of fampiridina in improving cognitive function of patients with multiple sclerosis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002558-64-IT

Enrollment

123

Registered

2013-10-16

Start date

2013-12-18

Completion date

Unknown

Last updated

2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MULTIPLE SCLEROSIS MedDRA version: 20.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: fampyra Product Name: FAMPYRA Pharmaceutical Form: Tablet INN or Proposed INN: FAMPRIDINE CAS Number: 504-24-5 Current Sponsor code: CP1/2013 Concentration unit: mg milligram(s) Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To analyze the effects of the drug on cognitive function in MS patients measured with Symbol Digit Modalities Test (SDMT). ;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 . 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) ;Timepoint(s) of evaluation of this end point: 12 WEEKS	—

Measure

Time frame

Main Objective: To analyze the effects of the drug on cognitive function in MS patients measured with Symbol Digit Modalities Test (SDMT). ;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 . 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) ;Timepoint(s) of evaluation of this end point: 12 WEEKS

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Secondary

Measure	Time frame
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 . 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 .	—

Measure

Time frame

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 . 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 .

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Countries

Italy

Contacts

Public Contactuoc neurologia a

dipartimento di neurologia e psichiatria

carlo.pozzilli@uniroma1.it00390649914682

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026