A trial to determine bexarotene's safety and tolerability and its ability to promote brain repair in patients with multiple sclerosis

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2015
INTERVENTION: Participants are randomly allocated into two groups who receive a different medication for a period of nine months. Those in the first group are given Bexarotene and those in the second group are given a placebo. During the nine month study period, participants in both groups will have regular assessments. CONDITION: Topic: Neurological disorders; Subtopic: Neurological (all Subtopics); Disease: Multiple Sclerosis ; Nervous System Diseases ; Multiple Sclerosis PRIMARY OUTCOME: Number of adverse events and withdrawals attributable to bexarotene are determined at 9 months. SECONDARY OUTCOME: Change in mean lesional MTR between month 0 and month 6 for lesions selected for each patient. INCLUSION CRITERIA: 1. Aged between 30 and 50 years inclusive 2. Able to provide informed consent 3. Relapsing remitting multiple sclerosis as per the McDonald 2010 criteria, including an MRI satisfying the radiological criteria 4. At least five T2 lesions, attributable to MS, on baseline MRI brain scan 5. Kurtzke Expanded Disability Status Scale (EDSS) 3.0‐6.0 6. At least one relapse in the two years prior to screening 7. At the time of screening (and for at least the last 6 months) being treated with interferon‐beta (any preparation) 8. Able and willing to comply with all study requirements
Epistemonikos ID: 389bcd47a4c8d81abfa5086eeb3f50a1b8adf126
First added on: Aug 23, 2024