MODAFIMS: A Trial to Evaluate Predictors of Response to MODAFinil in Patients With Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorClinical Academic Center (2CA-Braga)
About this trial
This is a phase II/exploratory clinical trial with a single-center, open-label design to evaluate the effect of modafinil on cognitive deficits in adult patients with multiple sclerosis and identify predictors of response using functional Magnetic Resonance Imaging (fMRI).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is willing and able to give informed consent for the participation in the trial.
Patients that are able to read and write.
Male or female, aged between 18 and 64 years old at the time of signing the ICF.
Diagnosed with Relapsing-Remitting MS or Clinically Isolated Syndrome, according to McDonald 2017 diagnostic criteria (Thompson et al., 2018).
Disqualifiers
Female participant who is pregnant, breastfeeding or planning pregnancy during the trial.
Participants who have participated in another research trial involving an investigational product within the past 5 half-lives of the other investigational product.
Participants who have any disability that, in the opinion of the investigator, significantly interferes with the neuropsychological testing and/or the tasks in the functional MRI.
Participants not able to undergo MRI scanning.
Trial design
Design model
Single group
Treatments tested in this trial
Modafinil Generis 100 mg
DrugAll participants enrolled in the study will receive the study intervention drug (Modafinil Generis 100 mg). Dose 200 mg once per day (2 tablets of 100 mg) in the morning for 3 months (84 days), Oral administration
Treatment groups
64 Participants
are divided into 1 treatment groupGroup A: Modafinil Generis 100 mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute changes in brain fuction and connectivity measured using resting state fMRI.
Acute changes in brain functional connectivity at rest will be measured using resting-state fMRI through Echo-planar imaging (EPI) sequences.
Time frame
Day 1 (baseline): before and 3 hours (± 30 minutes) after modafinil administration.2
Long-term changes in brain function and connectivity measured using resting state fMRI.
Long-term changes inbrain functional connectivity at rest will be measured using resting-state fMRI through Echo-planar imaging (EPI) sequences.
Time frame
Day 1 (baseline), 3 hours (± 30 minutes) after medication; and Day 84 (3 months after treatment with modafinil), 3 hours (±30 minutes) after medication.Secondary outcomes
1
Acute changes in brain function and connectivity measured using a Go/no-Go task fMRI.
Acute changes in brain activity during a Go/No-Go task, measured using task-based fMRI through Echo-planar imaging (EPI) sequences.
Time frame
Baseline (day 1): before and 3 hours (± 30 minutes) after modafinil administration.2
Long-term changes in brain function and connectivity measured using a Go/no-Go task fMRI.
Long-term changes in brain activity during a Go/No-Go task, measured using task-based fMRI through Echo-planar imaging (EPI) sequences.
Time frame
Day 1 (baseline), 3 hours (± 30 minutes) after medication; and Day 84 (3 months after treatment with modafinil), 3 hours (±30 minutes) after medication.3
SDMT score
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.
Time frame
Day 1 (baseline) and Day 84 (3 months after treatment)4
Stroop test
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.
Time frame
Screening and Day 84 (3 months after treatment)Sponsors and contacts
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Source ClinicalTrials.gov