E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
MULTIPLE SCLEROSIS |
SCLEROSI MULTIPLA |
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E.1.1.1 | Medical condition in easily understood language |
DISEASE OF THE CENTRAL NERVOUS SYSTEM |
MALATTIA DEL SISTEMA NERVOSO |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028245 |
E.1.2 | Term | Multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To analyze the effects of the drug on cognitive function in MS patients measured with Symbol Digit Modalities Test (SDMT).
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Miglioramento della velocità di processazione delle informazioni misurato con il Symbol Digit Modalities Test (SDMT). |
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E.2.2 | Secondary objectives of the trial |
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 . |
Miglioramento nel Paced Auditory Simbol Test (PASAT), STROOP test, Tower of London (TOW) scores, Selective Reminding Test (SRT), 10/36 Spatial Recall Test. Miglioramento nel Multiple Sclerosis Impact Scale (MSIS-29) nella Fatigue Impact Scale (mFIS), e nella Beck Depression Inventory (BDI). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
un età tra 18 e 65 anni (inclusi) ; una compromissione cognitiva definita come un punteggio inferiore al decimo percentile in almeno un test della batteria utilizzata in fase di screening. |
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E.4 | Principal 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. |
ricaduta clinica nei precedenti 60 giorni , storia di depressione maggiore o psicosi identificata mediante il Beck Depression Inventory-IA (cut off =19); storia di crisi comiziali , qualunque condizione in grado di interferire con la conduzione dello studio. Introduzione di qualunque terapia preventiva per MS o farmaco per umore, fatica o prestazioni cognitive nel mese precedente.. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To analyze the effects of the drug on speed of information processing measured with Symbol Digit Modalities Test (SDMT)
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Miglioramento della velocità di processazione delle informazioni misurato con il Symbol Digit Modalities Test (SDMT) . |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 . |
Miglioramento nel Paced Auditory Simbol Test (PASAT), STROOP test, Tower of London (TOW) scores, Selective Reminding Test (SRT), 10/36 Spatial Recall Test. Miglioramento nel Multiple Sclerosis Impact Scale (MSIS-29) nella Fatigue Impact Scale (mFIS), e nella Beck Depression Inventory (BDI). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
EVALUATION OF FAMPRYDINE EFFECTS ON SECONDARY ENDPOINTS |
VALUTAZIONE SULLA FUNZIONE COGNITIVA DELLA FAMPRIDINA |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |