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 aged 18 to 60 years old (male or female)
• People who are generally in stable health, based on a physical check-up, medical history, and vital signs
• People who have been diagnosed with multiple sclerosis (MS) according to the McDonald 2024 diagnostic criteria, as confirmed by the trial doctor reviewing medical records
• People who experience fatigue as one of their main symptoms, with a score of 33 or higher on a standard fatigue questionnaire called the MFIS
• People who score 10 or higher on a standard sleepiness questionnaire called the ESS
• People who are able to walk at least 20 feet (about 6 metres) with the help of walking aids on both sides
• People who have access to the internet and email, and are able to use a computer, tablet, or smartphone
• People who own an Android smartphone or an iPhone
• People who agree to use a medically accepted form of contraception for the entire duration of the study
• People who are willing and able to follow the study schedule and all other study requirements
• People who are willing and able to sign a written consent form

Who may not be able to join:

• People with a history of coronary artery disease or heart failure
• People with high blood pressure that is not well controlled, including those with a history of high blood pressure and a blood pressure reading above 160/100 at screening
• People with a known history of uncontrolled diabetes (with a recent HbA1c blood test result above 7.0%), a BMI over 35, or high cholesterol levels above certain thresholds (confirm with trial site for exact values)
• People who are currently taking medications or receiving treatments that raise blood pressure or heart rate, as determined by the trial doctor reviewing their medications
• People with a history of stroke or disease affecting the blood vessels in the brain
• People with a medical or neurological condition other than MS that causes excessive sleepiness
• People with a history of phenylketonuria (a rare inherited condition) or a known allergy or sensitivity to phenylalanine-derived products
• People with a history of alcohol or drug misuse within the past two years
• People with a history of psychosis or bipolar disorder
• People with a history of irregular heart rhythms (cardiac arrhythmias)
• People who use any product with stimulating or sedating effects, unless they have been on the same steady dose for at least one month before screening and agree to keep that dose unchanged throughout the study
• People who have used a type of medication called a MAO inhibitor within the past 14 days
• People who are pregnant or breastfeeding
• People who have used medications for treating fatigue — including amantadine, modafinil, armodafinil, or amphetamine-like stimulants — within the two weeks before the screening visit
• People with a known history of moderate or severe kidney problems (confirm with trial site for exact definition)

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