Phase 2 Multiple Sclerosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing and able to give their consent to take part in the trial
• People who can read and write
• People aged between 18 and 64 years old at the time of signing the consent form
• People who have been diagnosed with Relapsing-Remitting MS or Clinically Isolated Syndrome (an early possible sign of MS), based on recognised 2017 diagnostic guidelines
• People whose MS-related disability level falls below a certain threshold on a standard scale used by neurologists (confirm with trial site)
• People who feel they have been experiencing problems with their memory or thinking
• People whose score on a standard thinking and processing speed test (called the SDMT) is 55 or below at the screening visit
• Female participants who could become pregnant, and male participants whose partner could become pregnant, must be willing to use effective non-hormonal-only contraception throughout the full 6 months of the trial
• Male participants must agree not to donate semen from the first dose of the study treatment until at least 90 days after the last dose
• People who, in the trial doctor's opinion, are able and willing to follow all trial requirements

Who may not be able to join:

• Female participants who are pregnant, breastfeeding, or planning to become pregnant during the trial
• People who have taken part in another clinical trial involving an experimental treatment within a recent timeframe based on that treatment's properties (confirm with trial site)
• People who have a disability that, in the trial doctor's opinion, would significantly interfere with thinking/memory tests or with functional MRI tasks
• People who are unable to have an MRI scan
• People who have any medical reason why they should not take modafinil (the study drug), such as a known allergy or sensitivity to modafinil or any of its ingredients, or a documented bad reaction to modafinil in the past
• People with certain inherited conditions affecting how their body processes sugars, specifically hereditary galactose intolerance, complete lactase deficiency, or glucose-galactose malabsorption
• People with a history of certain heart conditions, including enlargement of the left side of the heart, a specific type of lung-related heart condition, or a heart valve condition (mitral valve prolapse) that previously caused problems when taking brain-stimulating medications
• People currently taking modafinil or armodafinil
• People currently using other stimulant substances, including amphetamines, cocaine, bupropion, or ginkgo biloba, or who consume more than 500 mg of caffeine-like substances per day (for example, more than about 5 espresso coffees or 100 g of dark chocolate daily)
• People with a significant neurological condition other than MS, such as epilepsy
• People with a significant psychiatric history, such as schizophrenia, bipolar disorder, major depression, severe anxiety, or a history of aggressive or hostile behaviour
• People who have attempted suicide in the last 2 years, or who have had serious thoughts of suicide with intent in the 6 months before the screening visit
• People with significant sleep problems classified above a certain severity level (confirm with trial site)
• People with a history of severe allergic reactions to any medicine
• People with a clinically significant abnormality in their heart trace (ECG) results
• People with a known immune deficiency condition
• People whose liver enzyme levels (ALT) are more than 3 times the accepted upper limit in blood tests at screening
• People who test positive for HIV, Hepatitis B, or Hepatitis C
• People whose kidneys are not functioning well enough, based on a standard calculation (confirm with trial site)
• People with a history of alcoholism or drug misuse
• People who smoke more than 20 cigarettes per day on average
• People with a physical limitation that would interfere with computer-based thinking tests, such as weakness in the arms or significantly reduced vision even with glasses or contact lenses
• People at increased risk of seizures, those with a history of heart rhythm problems, or those with uncontrolled moderate to severe high blood pressure
• People currently taking warfarin or other medications listed as prohibited by the trial (confirm with trial site)
• People whose score on a standard sleepiness questionnaire is above 10 at the screening visit, or who have a known sleep disorder
• People who have any other condition that, in the trial doctor's opinion, makes participation unsuitable

Important: Always verify eligibility with the trial site directly before applying.