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EFFECTS OF GLATIRAMER ACETATE ON TISSUE DAMAGE, CORTICAL FUNCTIONS AND FATIGUE IN MULTIPLE SCLEROSIS: A MORPHO-FUNCTIONAL MRI STUDY.

EFFECTS OF GLATIRAMER ACETATE ON TISSUE DAMAGE, CORTICAL FUNCTIONS AND FATIGUE IN MULTIPLE SCLEROSIS: A MORPHO-FUNCTIONAL MRI STUDY.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-000150-31-IT
Enrollment
Unknown
Registered
2011-12-28
Start date
2011-04-13
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Multiple Sclerosis patients MedDRA version: 14.1 Level: HLGT Classification code 10012303 Term: Demyelinating disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disord

Interventions

Trade Name: COPAXONE Pharmaceutical Form: Solution for injection INN or Proposed INN: Glatiramer acetate Concentration unit: mg milligram(s) Concentration number: 20-

Sponsors

FONDAZIONE DON CARLO GNOCCHI ONLUS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: - Age between 18 and 60 years; - Diagnosis of multiple sclerosis, according to the revised McDonald criteria [37]; - Relapsing-remitting or benign course; - EDSS score between 0.0 and 5.5 [38]; - For BMS: disease duration of 15 years or longer, EDSS =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: - Relapse or corticosteroid treatment within 30 days before study entry, - Chronic use of psychotropic drugs - Use of other disease-modifying treatments in the previous six months - Clinically significant systemic diseases.

Design outcomes

Primary

MeasureTime frame
Main Objective: Against this background, the present case-control group study has been designed with the aim to evaluate the impact of Glatiramer Acetate treatment on Multiple Sclerosis-related fatigue, under both a clinical and a paraclinical point of view.;Secondary Objective: Secondary outcome will be to evaluate the effect of treatment on clinical and MRI outcomes related to the symptom “fatigue” and in particular related to functioning of its brain networks.;Primary end point(s): Against this background, the present case-control group study has been designed with the aim to evaluate the impact of Glatiramer Acetate treatment on Multiple Sclerosis-related fatigue, under both a clinical and a paraclinical point of view.—

Countries

Italy

Outcome results

None listed

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