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

• Register: EUCTR
• Last refreshed on: 16 October 2017
• Main ID: EUCTR2013-002558-64-IT
• Date of registration: 16/10/2013
• Prospective Registration: Yes
• Primary sponsor: dipartimento di neurologia e psichiatria
• Public title: improvement of cognitive performance after administration of fampridina in patients with multiple sclerosis
• Scientific title: A randomised, placebo-controlled trial investigating the role of fampiridina in improving cognitive function of patients with multiple sclerosis.
• Date of first enrolment: 18/12/2013
• Target sample size: 123
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002558-64
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Italy

Contacts

• Name: uoc neurologia a
• Affiliation: dipartimento di neurologia e psichiatria

• Name: uoc neurologia a
• Affiliation: dipartimento di neurologia e psichiatria

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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)
Concentration type: equal
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 12 WEEKS

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)

Main Objective: To analyze the effects of the drug on cognitive function in MS patients measured with Symbol Digit Modalities Test (SDMT).

Secondary Outcome(s)

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 .

Timepoint(s) of evaluation of this end point: 12 WEEKS

Secondary ID(s)

CP1/2013

Source(s) of Monetary Support

azienda farmaceutica biogen idec international gmbh