Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06190912
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-12-11
Brief Title:
Safety of Bryostatin in Patients With MS
Sponsor:
Robert Fox
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Single-Arm Single-Site Single-Dose Phase 1 Study Assessing the Safety of Bryostatin in the Treatment of Patients With Multiple Sclerosis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None