Safety of Bryostatin in Patients With MS

A Single-Arm, Single-Site, Single-Dose Phase 1 Study Assessing the Safety of Bryostatin in the Treatment of Patients With Multiple Sclerosis

NCT06190912•Robert Fox

View on ClinicalTrials.gov

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 (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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Inclusion
•1. Written informed consent signed by participant
•2. English-speaking
•3. Hospital Anxiety and Depression Scale \<11
•4. Male and female participants, 18-65 years of age inclusive
•5. Established diagnosis of MS, as defined by the 2017 revision of McDonald Diagnostic Criteria (any form of MS). A diagnosis of MS must be confirmed at the time of the screening visit.
•6. Processing Speed Test (PST) z-score between -1.0 and -2.5
•7. EDSS between 0.0 and 7.0, inclusive.
•8. Adequate vision and motor function to participate in assessment procedures
•9. Participants must be off of a DMT or on a stable dose of a DMT for at least 1 year prior to entry into the study, and the dose should not change during the study unless a change is required by a clinically significant change in the participant's status.
+38 more criteria

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Key Dates

Start Date

June 26, 2024

Primary Completion Date

June 15, 2026

Completion Date

July 15, 2026

Last Updated

April 24, 2025

Enrollment

ESTIMATED participants

Conditions

Multiple Sclerosis

Interventions

Bryostatin 1

DRUG

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

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Secondary Progressive Multiple Sclerosis (SPMS)

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RECRUITINGNA

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Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety of Bryostatin in Patients With MS

Inclusion Criteria

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