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
Qualifiers
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
Treatments tested in this trial
- Modafinil Generis 100 mg
Treatment groups
64 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov