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

Phase 2

Completed

• Conditions: Topic: Neurological disorders; Subtopic: Neurological (all Subtopics); Disease: Multiple Sclerosis; Nervous System Diseases; Multiple Sclerosis

• Registration Number: ISRCTN14265371
• Lead Sponsor: Cambridge University Hospitals NHS Foundation trust & University of Cambridge (Comprehensive)

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34418398/ (added 23/08/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35587315/ (added 07/11/2023) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36116011/ (added 07/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-14
• Study Completion: 2019-11-15
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

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

Exclusion Criteria

1. Pregnant, lactating or planning pregnancy during course of trial
2. Female and male participants unwilling or unable to use two reliable non-hormonal methods of contraception during the course of the trial and for one month thereafter
3. Taking gemfibrozil
4. Taking disease-modifying therapy for multiple sclerosis, other than interferon-beta within the previous six months
5. Significant renal or hepatic impairment (Grade III or worse)
6. Known hypersensitivity to bexarotene or to any of the excipients of the product
7. Unwillingness to take a product containing gelatin
8. Known reaction to gadolinium (within the contrast agent used for MRI scans)
9. History of pancreatitis
10. Fasting triglycerides over 2.3 mmol/L or baseline dyslipidaemia requiring treatment
11. Known hypervitaminosis A
12. Uncontrolled thyroid disease
13. Excessive alcohol consumption (>24units/week for men, >14 units/week for women)
14. Uncontrolled diabetes mellitus
15. Biliary tract disease
16. Hereditary fructose intolerance
17. Use of CYP3A4-substrates (ketoconazole, itraconazole, protease inhibitors, clarithromycin and erythromycin) or CYP3A4-inducers (rifampicin, phenytoin, dexamethasone or phenobarbital), unless patients are willing to stop these (and it is safe to do so)
18. Any other significant disease, disability or investigation result which in the opinion of the Investigator may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of adverse events and withdrawals attributable to bexarotene are determined at 9 months.

Secondary Outcome Measures

Name	Time	Method
Change in mean lesional MTR between month 0 and month 6 for lesions selected for each patient.