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 already enrolled in a related study called protocol 09-I-0032
• People who have a confirmed diagnosis of multiple sclerosis (MS)
• People who are 18 years of age or older at the time of joining the study
• People whose MS-related disability falls within a certain measured range on a standard disability scale (EDSS score between 1.0 and 7.5)
• For the "progressive MS" group: people whose MS has been measurably and steadily worsening at a certain rate over time, while on a stable treatment or no treatment, based on a specific scoring system called CombiWISE (confirm with trial site for exact measurement details)
• For the "non-progressing MS with lasting disability" group: people whose MS is no longer actively worsening but who still have a measurable level of disability that has not improved, based on CombiWISE scores (confirm with trial site for exact thresholds)
• People who are able to become pregnant and are willing to use an accepted form of birth control throughout the study
• People who are currently taking an FDA-approved MS disease-modifying therapy (DMT), provided that therapy stays unchanged during the study (with specific rules applying if a therapy change becomes necessary — confirm with trial site)
• People who are willing and able to take part in all parts of the study
• People who are willing and able to give informed consent

Who may not be able to join:

• People with serious medical conditions that the study doctors believe could put them at significant risk of harm or prevent them from safely completing the study (examples include significant stroke-related disease, serious heart disease, blood clotting disorders, other brain or nerve disorders, substance abuse, or significant mental health conditions such as depression with thoughts of suicide, or inability to have an MRI scan)
• People with serious medical conditions other than MS that require ongoing treatment with immune-suppressing or immune-modifying medications
• People who are pregnant or breastfeeding
• People whose blood test results fall outside acceptable ranges, including: liver enzyme levels more than three times the normal upper limit; low white blood cell count; low platelet count; poor kidney function above a certain threshold; blood test evidence of HIV, HTLV-1, or active hepatitis A, B, or C infection; or a positive pregnancy test

Additional restrictions that apply only to certain specific drugs used within the trial (these do not exclude someone from the trial itself, only from being assigned a particular drug):

• Pioglitazone may not be assigned to people with heart failure, a history of bladder cancer, type 1 diabetes, an allergy to the drug, or those taking teriflunomide (Aubagio)
• Dantrolene may not be assigned to people with an allergy to the drug, liver disease or impairment, persistently abnormal liver test results, or a history of liver damage from alcohol or medications
• Pirfenidone may not be assigned to people with an allergy to the drug, liver disease or impairment, persistently abnormal liver test results, or people who smoke
• Cilostazol may not be assigned to people with an allergy to the drug, heart failure, bleeding disorders or active bleeding, or those taking certain MS medications that affect heart rhythm (such as fingolimod, ozanimod, siponimod, or ponesimod)
• Leucovorin may not be assigned to people with an allergy to the drug, active colorectal cancer, or vitamin B12 deficiency

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