MODAFIMS: A Trial to Evaluate Predictors of Response to MODAFinil in Patients With Multiple Sclerosis
NCT06592352, Phase 2, Recruiting, Clinical Academic Center (2CA-Braga)
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | MODAFIMS: A Trial to Evaluate Predictors of Response to MODAFinil in Patients With Multiple Sclerosis | ClinicalTrials.gov |
| NCT number | NCT06592352 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 64 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Clinical Academic Center (2CA-Braga) | ClinicalTrials.gov |
| Conditions | Multiple Sclerosis, Cognitive Impairment | ClinicalTrials.gov |
| Interventions | Modafinil Generis 100 mg | ClinicalTrials.gov |
| First posted | 2024-09-19 | ClinicalTrials.gov |
| Last updated | 2025-08-13 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Acute changes in brain fuction and connectivity measured using resting state fMRI. | Day 1 (baseline): before and 3 hours (± 30 minutes) after modafinil administration. | Acute changes in brain functional connectivity at rest will be measured using resting-state fMRI through Echo-planar imaging (EPI) sequences. | ClinicalTrials.gov |
| Primary | Long-term changes in brain function and connectivity measured using resting state fMRI. | Day 1 (baseline), 3 hours (± 30 minutes) after medication; and Day 84 (3 months after treatment with modafinil), 3 hours (±30 minutes) after medication. | Long-term changes inbrain functional connectivity at rest will be measured using resting-state fMRI through Echo-planar imaging (EPI) sequences. | ClinicalTrials.gov |
| Secondary | Acute changes in brain function and connectivity measured using a Go/no-Go task fMRI. | Baseline (day 1): before and 3 hours (± 30 minutes) after modafinil administration. | Acute changes in brain activity during a Go/No-Go task, measured using task-based fMRI through Echo-planar imaging (EPI) sequences. | ClinicalTrials.gov |
| Secondary | Long-term changes in brain function and connectivity measured using a Go/no-Go task fMRI. | Day 1 (baseline), 3 hours (± 30 minutes) after medication; and Day 84 (3 months after treatment with modafinil), 3 hours (±30 minutes) after medication. | Long-term changes in brain activity during a Go/No-Go task, measured using task-based fMRI through Echo-planar imaging (EPI) sequences. | ClinicalTrials.gov |
| Secondary | SDMT score | Day 1 (baseline) and Day 84 (3 months after treatment) | Symbol Digit Modalities Test (SDMT) is a cognitive function test to assess visual attention and information processing speed, which involves a simple substitution task. The SDMT includes a reference key of 9 symbols, each paired with a single digit. Below the reference key are rows of symbols arranged randomly. The participant will have 90 seconds to say out loud the number that corresponds to each symbol. Answers are registered by the rater in the SDMT form and the score corresponds to the number of correct answers given within the 90-seconds interval. A decrease of 4 points from baseline on the SDMT is considered a meaningful worsening. | ClinicalTrials.gov |
| Secondary | Stroop test | Screening and Day 84 (3 months after treatment) | The Stroop test is a measure of executive function, including selective attention capacity, processing speed, behaviour inhibition and interference resistance. The performance in this test is measured by the interference index. | ClinicalTrials.gov |
| Secondary | MS-QoL-54 total score | Screening and Day 84 (3 months after treatment). | Multiple Sclerosis Quality of Life-54 (MS-QoL-54) is a multidimensional health-related quality of life (QoL) measure combining generic and MS-specific items into a single tool. MS-QoL-54 has a total of 54-items generating 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall QoL, and sexual function. The single item measures are satisfaction with sexual function and change in health. The summary scores are the physical health composite summary and the mental health composite summary. Scores range from 0 to 100, with higher values representing a better QoL. | ClinicalTrials.gov |
| Secondary | WPAI:MS total score | Screening and Day 84 (3 months after treatment). | The Work Productivity and Activity Impairment Questionnaire for MS is a 6-item questionnaire which measures the impact of MS on the patients' work productivity (including the duration of work time missed due to the disease and decrease in productivity when working while experiencing symptoms) and non-working activities (for example, childcare) during the past seven days. | ClinicalTrials.gov |
| Secondary | MFIS total score | Screening and Day 84 (3 months after treatment). | The Modified Fatigue Impact Scale (MFIS) is a 21-item tool used to rate the impact of fatigue during the last 4 weeks on a 5-point Likert scale, from "Never" (0) to "Almost always" (4). The total score is the sum of all items from 0 to 84, with higher scores indicating greater impact of fatigue. | ClinicalTrials.gov |
| Secondary | PDQ total score | Screening and Day 84 (3 months after treatment with modafinil) | Perceived Deficits Questionnaire (PDQ) is a 20-items self-report measure to assess perceived cognitive impairment during the past 4 weeks. The total score ranges from 0 to 80, and higher scores reflect greater perceived cognitive impairment. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Go/No-Go Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)