Actively Recruiting
MODAFIMS: A Trial to Evaluate Predictors of Response to MODAFinil in Patients With Multiple Sclerosis
Led by Clinical Academic Center (2CA-Braga) · Updated on 2025-08-13
64
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
MODAFIMS: A Trial to Evaluate Predictors of Response to MODAFinil in Patients With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give informed consent for the trial
- Able to read and write
- Male or female aged 18 to 64 years at time of consent
- Diagnosed with Relapsing-Remitting MS or Clinically Isolated Syndrome per McDonald 2017 criteria
- Expanded Disability Status Score (EDSS) less than 6.5
- Has subjective cognitive complaints
- Symbol Digit Modalities Test (SDMT) score at screening of 55 or less
- Females of childbearing potential and male partners agree to use effective contraception (non-hormonal) during trial and 3-month follow-up
- Male participants agree not to donate semen from first dose until 90 days after last dose
- Able and willing to comply with all trial requirements as judged by investigator
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the trial
- Participated in another investigational product trial within past 5 half-lives
- Disability significantly interfering with neuropsychological testing or fMRI tasks
- Unable to undergo MRI scanning
- Contraindication to modafinil such as hypersensitivity or prior adverse reaction
- Known hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
- History of left ventricular hypertrophy, cor pulmonale, or mitral valve prolapse syndrome linked to CNS stimulants
- Current use of modafinil, armodafinil, or other psychostimulants and excessive methylxanthine intake
- Significant neurological history aside from MS (e.g., epilepsy)
- Significant psychiatric history (e.g., schizophrenia, bipolar disorder, major depression, severe anxiety, aggression)
- History of suicide attempt in last 2 years or suicidal ideation with intent in last 6 months
- Significant insomnia (grade >1 CTCAE v5)
- History of severe hypersensitivity reactions to any medicine
- Clinically significant ECG abnormalities
- Known immunodeficiency syndrome
- ALT values >3 times upper normal limit at screening
- Positive for HIV, Hepatitis B or C
- Creatinine clearance <20 ml/min
- History of alcoholism or drug abuse
- Average smoking more than 20 cigarettes daily
- Disability interfering with CT procedures
- Increased risk of seizures, cardiac arrhythmias, or uncontrolled moderate/severe hypertension
- Taking warfarin or prohibited medications
- Sleep complaints with Epworth Sleepiness Scale score >10 or known sleep disorder
- Any condition that contraindicates participation per investigator opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinical Academic Center - Braga (2CA-Braga)
Braga, Portugal, 4710-243
Actively Recruiting
Research Team
M
Mónica Gonçalves
CONTACT
R
Rosana Magalhães
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here