High-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy. - ND

• Conditions: patients with multiple sclerosis; MedDRA version: 9.1Level: PTClassification code 10028245

• Registration Number: EUCTR2010-023678-38-IT
• Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-02
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

-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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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