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 have been formally diagnosed with multiple sclerosis (MS), and if taking MS medication, have been on a stable dose for at least 3 months with no signs of liver problems
• People who have been experiencing moderate to severe ongoing pain (rated at least a moderate level on a 0–10 scale) for at least 3 months
• People who are willing to keep their pain medication the same throughout the study period
• People who have had a blood test checking certain liver levels (AST, ALT, and bilirubin) within the past 90 days

Who may not be able to join:

• People who have a current diagnosis of shift work sleep disorder or narcolepsy (confirmed by sleep studies)
• People who have had an MS relapse (flare-up) in the past 30 days before screening (the trial site may reconsider eligibility after that 30-day period has passed)
• People whose pain is caused by cancer
• People who are pregnant or breastfeeding
• People who are currently using cannabis or cannabinoid products, or who are unwilling to stop using them for 30 days before the study and until the final follow-up at the end of the study
• People who are unwilling to use contraception from the screening stage until the end of the treatment period
• People who currently have thoughts of suicide with a plan or intent (the trial site will arrange assessment and urgent mental health support for these individuals)
• People with current severe depression, based on a specific depression questionnaire score (PHQ-9 score of 17 or above, with strong indicators of depressed mood)
• People with a history of mania or schizophrenia
• People with a known allergy or sensitivity to cannabinoids, or to the specific study drugs (Epidiolex® or Dronabinol) or their ingredients, such as sesame oil
• People with a history of certain serious heart conditions, including a heart attack or stroke in the past 6 months, unstable chest pain, certain structural heart problems, severe coronary artery disease, or advanced heart failure
• People with significantly impaired liver function, based on recent blood test results outside accepted levels
• People with a history of a seizure disorder (recurring, unexplained seizures) or certain types of head injury that may increase seizure risk
• People with a history of misusing prescription medications or illegal drugs such as cocaine, amphetamines, methamphetamine, or heroin
• People currently at risk of alcohol misuse, based on a score of 8 or above on a standard alcohol use questionnaire (AUDIT)
• People currently taking warfarin, valproate, or clobazam
• People currently taking certain medications that interact with specific liver enzymes responsible for processing drugs (known as moderate or strong CYP3A4 inhibitors — some short-term exceptions may apply; confirm with trial site)
• People currently taking certain other medications that strongly affect the same liver enzymes (strong CYP3A4 or CYP2C19 inducers — some exceptions apply; confirm with trial site)
• People currently taking certain other medications that affect related liver enzymes (CYP2C9 inhibitors or inducers, or certain drugs with a narrow safe dosage range; confirm with trial site)
• People currently taking certain other medications processed by a specific liver enzyme (CYP2C19), with some exceptions at the treating doctor's discretion (confirm with trial site)
• People who are unwilling to avoid grapefruit and grapefruit products during the treatment period
• People currently taking opioid pain medicines (tramadol is an exception and is permitted)
• People who work as commercial drivers, or in jobs involving significant heights or heavy machinery
• People who have had a car crash or near-crash due to unmanaged sleepiness in the past 6 months
• People with significant cognitive (thinking and memory) difficulties, based on a short screening test (3 or more errors on a six-item cognitive screener)
• People with a high level of MS-related disability, based on a standard MS disability scale score of 8.0 or above
• People with blood pressure that is too high (above 180/120 mmHg) or too low (below 90/60 mmHg) at screening, or who have a history of fainting related to a drop in blood pressure when standing
• People with a resting heart rate below 50 or above 100 beats per minute at screening
• People with any other medical, neurological, sleep, psychiatric condition, or treatment that the trial investigators consider could affect safety or suitability for the trial

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