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MODAFIMS: An open-label, single-center clinical trial to evaluate predictors of response to MODAFinil in the treatment of cognitive deficits in patients with Multiple Sclerosis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501414-53-00
Acronym
MODAFIMS
Enrollment
64
Registered
2024-06-07
Start date
2024-08-21
Completion date
Unknown
Last updated
2025-03-18

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

Conditions

Multiple sclerosis

Brief summary

Changes in brain function and connectivity measured using resting state fMRI (at baseline and after 3 months of treatment with Modafinil). Functional MRI will be performed at baseline, before and 3h (±30 min) after Modafinil administration, and at the end of treatment (3-month visit).

Detailed description

Changes in brain function and connectivity measured using a Go/no-Go task fMRI., Changes in patient reported outcomes (PROs) and neuropsychological tests - Perceived Deficits Questionnaire (PDQ), Symbol Digit Modalities Test (SDMT), Stroop test measured as interference index, MS-specific QoL questionnaire, Work Productivity and Activity Impairment Questionnaire for MS (WPAI:MS) and Modified Fatigue Impact Scale (MFIS). These assessments will occur in the screening or baseline visits and at the end of treatment (3-month visit).

Interventions

DRUGModafinil Generis 100 mg comprimidos

Sponsors

CCAB Centro Clinico Academico Braga Associacao
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Changes in brain function and connectivity measured using resting state fMRI (at baseline and after 3 months of treatment with Modafinil). Functional MRI will be performed at baseline, before and 3h (±30 min) after Modafinil administration, and at the end of treatment (3-month visit).

Secondary

MeasureTime frame
Changes in brain function and connectivity measured using a Go/no-Go task fMRI., Changes in patient reported outcomes (PROs) and neuropsychological tests - Perceived Deficits Questionnaire (PDQ), Symbol Digit Modalities Test (SDMT), Stroop test measured as interference index, MS-specific QoL questionnaire, Work Productivity and Activity Impairment Questionnaire for MS (WPAI:MS) and Modified Fatigue Impact Scale (MFIS). These assessments will occur in the screening or baseline visits and at the end of treatment (3-month visit).

Countries

Portugal

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026