patients with multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10028245
Conditions
Interventions
Trade Name: MANTADAN*20CPR 100MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Amantadine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical for
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -No relapses and steroid treatment in the three months preceding study initiation; - No or only modest overall neurological impairment defined as an EDSS score of 4.0 or less; - No visual deficits; - No right upper limb impairment that may interfere with fMRI performance; - No pain disturbances; - No other neurological diseases; - No psychiatric or mood disorders; - No evidence of depression at the Montgomery and Asberg Depression Rating Scale (1979); - No epilepsy, learning disability, head injury, episodes of loss of consciousness or severe ongoing stressors; - No history of drug or alcohol abuse; - No concomitant therapy with antidepressant, baclofen, psychoactive, and steroids drugs as well as symptomatic treatment for fatigue; - For patients treated with interferons (IFN) or other immunomodulants: treatment should be started at least six months before MRI acquisition and fatigue should not be a side effect of IFN treatment; - No major medical illness including renal, hepatic or cardiac disease, or diabetes mellitus. - No pregnancy or breastfeeding; 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Recurrence-and steroid treatment in the three months preceding the start of the study; - Even modest global neurological damage defined by EDSS scores of 4.0 or less; - Visual impairment; - Direct damage to the upper limbs that may interfere with fMRI; - Pain disorder; - Other neurological disease; - Psychiatric disorder or mood; - Evidence of depression and the Montgomery Asberg Depression Rating Scale (1979); - Epilepsy, learning disabilities, head injury, episodes of loss of consciousness or severe stressors in progress; - Previous abuse of drugs or alcohol; - Concomitant treatment with antidepressants, baclofen, psychoactive drugs and steroids, as well as symptomatic treatment for fatigue; - Patients treated with interferon (IFN) or other immunomodulatory treatment with recent - Serious illness such as kidney disease, liver or heart, or diabetes mellitus. -Pregnant or lactating;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluate the effects on brain activation patterns of drugs that are widely used in clinical practice for the treatment of fatigue in multiple sclerosis;Secondary Objective: evaluate the effects on brain activation patterns of drugs that are widely used in clinical practice for the treatment of fatigue in multiple sclerosis;Primary end point(s): evaluate the effects on brain activation patterns of drugs that are widely used in clinical practice for the treatment of fatigue in multiple sclerosis | — |
Countries
Italy
Outcome results
None listed