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Protein Kinase C Modulator

Bryostatin for Multiple Sclerosis

Phase 1
Recruiting
Led By Robert J Fox, MD
Research Sponsored by Robert Fox
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female participants, 18-60 years of age inclusive
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.
Must not have
Creatinine clearance (CL) of <45ml/min
Use of vitamin E > 400 International Units (IU) per day within 14 days prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes from baseline to week 11, week 28, and week 40
Awards & highlights
No Placebo-Only Group

Summary

This trial is a study to test the safety of a drug called bryostatin in people with multiple sclerosis who are already taking other medications for their condition. It will be conducted at one location and

Who is the study for?
This trial is for individuals with multiple sclerosis (MS) who are currently on any disease-modifying therapy. The study is focused on understanding the safety of a single dose of Bryostatin in this specific patient population.
What is being tested?
The trial is testing the safety profile of a medication called Bryostatin in patients with MS. It's a phase 1 study, which means it's an early-stage trial to assess how safe the drug is and how the body responds to it.
What are the potential side effects?
Since this information was not provided, we cannot specify potential side effects. However, as with many trials at this stage, participants will be closely monitored for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.
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I have been diagnosed with multiple sclerosis according to the 2017 McDonald criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is reduced with a creatinine clearance below 45ml/min.
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I haven't taken more than 400 IU of vitamin E daily in the last 2 weeks.
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I do not have any major brain or nerve conditions other than MS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes from baseline to week 11, week 28, and week 40
This trial's timeline: 3 weeks for screening, Varies for treatment, and changes from baseline to week 11, week 28, and week 40 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
CNS inflammatory effects
Study Medication Discontinuation
Other study objectives
Exploratory Outcome: EDSS
Exploratory Outcome: MoCA
Exploratory Outcomes: BNT
+20 more

Side effects data

From 2017 Phase 2 trial • 147 Patients • NCT02431468
13%
Decreased appetite
11%
Fatigue
11%
Weight decreased
11%
Diarrhea
9%
Myalgia
9%
Infusion site cellulitis
9%
Fall
9%
Headache
6%
Contusion
6%
Urinary tract infection
6%
Infusion site extravasation
2%
Syncope
2%
Seizure
2%
Diabetic ketoacidosis
2%
Dementia Alzheimer's Type
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bryostatin 1 40ug
Placebo
Bryostatin 1 20ug

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bryostatin 1Experimental Treatment1 Intervention
Participants in this arm will receive treatment with Bryostatin 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bryostatin 1
2020
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

Robert FoxLead Sponsor
1 Previous Clinical Trials
Synaptogenix, Inc.UNKNOWN
Robert J Fox, MDPrincipal InvestigatorThe Cleveland Clinic
~13 spots leftby Apr 2026
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