Safety of Bryostatin in Patients With MS

Status Recruiting

Clinical Trial Summary

This is a single-site, single-arm, single-dose, Phase 1 study of the safety of bryostatin in participants with multiple sclerosis (MS) receiving any disease modifying therapy (DMT).

Clinical Trial Description

The study is 42 weeks in duration, including safety and exploratory outcomes evaluation at 30 days after the last full assessment (Week 28) and long-term follow-up at 12 weeks after the last full assessment (Week 40). Participants will receive a total of 14 doses over 26 weeks. Eligible participants will be treated with bryostatin over a 26-week period. Doses 1, 2, 8, and 9 of the study drug will be a loading dose 20% higher (i.e., 24 µg) than the assigned fixed dose and will be administered one week apart. Otherwise, the assigned fixed dose is 20 µg. Drug is administered intravenously (IV) by continuous infusion over 45 (±5) minutes. Participants are scheduled to receive 14 doses over 26 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06190912
Study type	Interventional
Source	The Cleveland Clinic
Contact	Alexis Novak
Phone	216-445-8597
Email	novaka5@ccf.org
Status	Recruiting
Phase	Phase 1
Start date	April 11, 2024
Completion date	August 2026

View Details

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