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Protein Kinase C Modulator

Bryostatin 1 for Multiple Sclerosis

Phase 1

Waitlist Available

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes from baseline to week 11, week 28, and week 40

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes from baseline to week 11, week 28, and week 40

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

CNS inflammatory effects

Study Medication Discontinuation

Other outcome measures

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%

Diarrhea

11%

Weight decreased

Myalgia

Infusion site cellulitis

Fall

Headache

Urinary tract infection

Infusion site extravasation

Contusion

Dementia Alzheimer's Type

Seizure

Diabetic ketoacidosis

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Bryostatin 1 40ug

Bryostatin 1 20ug

Placebo

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Robert FoxLead Sponsor

1 Previous Clinical Trials

20 Total Patients Enrolled

Synaptogenix, Inc.UNKNOWN

Robert J Fox, MDPrincipal InvestigatorThe Cleveland Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals who are 80 years or older eligible to participate in this clinical trial?

"This study is seeking individuals who are over 18 years old but below the age of 60 to participate as patients."

Answered by AI

What are the eligibility criteria for individuals to participate in this clinical study?

"To be considered eligible for this study, potential participants must have a diagnosis of multiple sclerosis and fall within the age range of 18 to 60. Approximately 20 individuals will be accepted into the clinical trial."

Answered by AI

What are the potential risks and hazards associated with Bryostatin 1 when administered to patients?

"Given that this trial is in Phase 1, the safety rating for Bryostatin 1 by our team at Power is a score of 1. This indicates that there is limited available data on both safety and efficacy."

Answered by AI

Are there any available positions for participants in this research study?

"According to the information available on clinicaltrials.gov, this specific study is not actively seeking participants at the moment. The trial was originally posted on February 1st, 2024 and was last updated on December 19th, 2023. However, it's worth noting that there are currently 519 other trials actively recruiting individuals for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety of Bryostatin in Patients With MS

Robert Fox 2024. "Safety of Bryostatin in Patients With MS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06190912.