Multiple SclerosisPhase 1NCT06190912
Safety of Bryostatin in Patients With MS
A Phase 1 study testing Bryostatin 1 in people with Multiple Sclerosis, run by Robert Fox at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Bryostatin 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2024to 15 Mar 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent signed by participant
- English-speaking
- Hospital Anxiety and Depression Scale <11
- Male and female participants, 18-65 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.
- Processing Speed Test (PST) z-score between -1.0 and -2.5
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- EDSS between 0.0 and 7.0, inclusive.
- Adequate vision and motor function to participate in assessment procedures
- 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.
- Females participating in the study must meet one the following criteria:
- Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy or tubal ligation) for at least 6 months or postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year) or
- If not postmenopausal, agree to use a double method of contraception, one of which is a barrier method (e.g., intrauterine device plus condom, spermicidal gel plus condom) 30 days prior to dosing until 30 days after last dose and have negative human chorionic gonadotropin (β-hCG) test for pregnancy at screening. Contraception methods resulting in an overall failure rate of <1 % per year are required for women of childbearing potential.
- Males who have not had a vasectomy must use appropriate contraception methods (barrier or abstinence) from 30 days prior to dosing until 30 days after last dose
- Participants should be in reasonably good health over the last 6 months and any chronic disease should be stable.
Who cannot join
- Evidence of significant CNS vascular disease on previous neuroimaging, including but not limited to cortical stroke, multiple infarcts, localized single infarcts in the thalamus, angular gyrus, multiple lacunar infarcts, or extensive white matter injury
- Clinically significant neurologic disease or condition other than MS, such as cerebral tumor, chronic subdural fluid collections, Huntington's Disease, Parkinson's Disease, normal pressure hydrocephalus, or any other diagnosis that could interfere with assessment of safety and efficacy
- Previous history of seizures or seizure disorders.
- Evidence of clinically significant unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurologic, or metabolic disease within the 6 months prior to enrollment. If there is a history of cancer, the participant should be clear of cancer for at least 2 years prior to screening. More recent history of basal cell or squamous cell carcinoma and melanoma in situ (Stage 0) may be acceptable after review by the Medical Monitor.
- Estimated Glomerular Filtration Rate (eGFR) of <45ml/min
- Poorly controlled diabetes (at the discretion of the Principal Investigator)
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- Use of vitamin E > 400 International Units (IU) per day within 14 days prior to screening
- Use of valproic acid and/or lithium within 14 days prior to screening
- Use of carbamazepine within 7 days prior to screening
- Use of teriflunomide within 90 days prior to screening
- Use of dalfampridine within 7 days of screening
- Current use of acetaminophen, ciprofloxacin, and/or trimethoprim/sulfamethoxazole
- Use of any potent or moderate inhibitor or inducer of CYP3A4, CYP2C8, or CYP2C9. Concomitant medicines will be examined on a case-by-case basis against the Flockhart Table by study investigator, and if needed, the Medical Monitor, to determine allowability
- Current use of St. John's Wort, within 2 weeks prior to screening
- Consumption of grapefruit juice from screening until end of study
- At the discretion of the PI, any medical or psychiatric condition that is unstable or may require the initiation of additional medication or surgical intervention during the course of the study
- Any screening laboratory values outside the laboratory reference ranges that are deemed clinically significant by the PI
- Use of an investigational drug within 30 days prior to screening
- Suicidality defined as active suicidal thoughts during the 6 months prior to screening or at Baseline [SBQ-R], or history of suicide attempt in previous 2 years, or at serious suicide risk in study neurologist or PI's judgment
- Major psychiatric illness such as currently uncontrolled major depression according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition4, current or past diagnosis of bipolar disorder, schizophrenia, or any other psychiatric disorder that might interfere with the assessments of safety or efficacy at the discretion of the PI
- Diagnosis of alcohol or drug abuse within the last 2 years
- History of prolonged QT or prolonged QT on screening ECG [QT correction with Bazett formula (QTcB) or QT correction by Fridericia (QTcF)>499 per central reader]5
- Acute or poorly controlled medical illness: blood pressure >180 mmHg systolic or 100 mmHg diastolic; myocardial infarction within 6 months; uncompensated congestive heart failure [New York Heart Association (NYHA) Class III or IV]
- Known to be seropositive for Hepatitis B or C, unless successful curative treatment for Hepatitis C (e.g., Harvoni) has been received, and there is documentation that there is no Hepatitis B/C virus detected 3 months after completion of treatment
- Known to be seropositive for human immunodeficiency virus (HIV)
- Pregnancy or breastfeeding during the study. A β-hCG serum pregnancy test will be performed at Screening for female patients of child-bearing potential.
- Aspartate Amino Transferase (AST) or Alanine Aminotransferase (ALT) >3x upper limit of normal (ULN) and total bilirubin >2x ULN or International Normalized Ratio (INR) >1.5
- History of significant bleeding disorders.
- Moderate baseline thrombocytopenia (platelets <100K/uL).
- Elevated INR (>2.0).
- Prior exposure to bryostatin, or known sensitivity to bryostatin or any ingredient in the study drug
- Any other concurrent medical condition, which in the opinion of the PI makes the participant unsuitable for the clinical study
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Bryostatin 1
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bryostatin 1Drug
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 group | Role | What they receive |
|---|---|---|
| Bryostatin 1 | Experimental | Participants in this arm will receive treatment with Bryostatin 1 Receives: Drug: Bryostatin 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Frequency of Adverse Events [Treatment Emergent AEs (TEAEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARS)]
Measured: Approximately 37 weeks
Study Medication Discontinuation
Frequency of study medication discontinuation and reason thereof
Measured: Approximately 37 weeks
CNS Inflammatory Effects
Potential CNS inflammatory effects as captured by clinical monitoring and MRI
Measured: Approximately 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start26 Jun 2024
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Why it stopped: Sponsor terminated funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Fox
- Sponsor type
- University, hospital or other
- Collaborators
- Synaptogenix, Inc.
- Responsible party
- Sponsor-investigator, Robert Fox, The Cleveland Clinic
- Investigators
- Robert J Fox, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190912
- Sponsor's protocol ID
- 24-099
- Status last verified
- Feb 2026
- First submitted
- 11 Dec 2023
- Last updated
- 31 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06190912
- Acronym / sponsor ID
- 24-099
- Conditions
- Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated funding.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Robert FoxUniversity, hospital or other
- Collaborators
- Synaptogenix, Inc.
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Posted 31 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bryostatin 1 | Experimental | Drug: Bryostatin 1Participants in this arm will receive treatment with Bryostatin 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent signed by participant
- English-speaking
- Hospital Anxiety and Depression Scale <11
- Male and female participants, 18-65 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.
Key exclusion criteria (32 listed)
- Evidence of significant CNS vascular disease on previous neuroimaging, including but not limited to cortical stroke, multiple infarcts, localized single infarcts in the thalamus, angular gyrus, multiple lacunar infarcts, or extensive white matter injury
- Clinically significant neurologic disease or condition other than MS, such as cerebral tumor, chronic subdural fluid collections, Huntington's Disease, Parkinson's Disease, normal pressure hydrocephalus, or any other diagnosis that could interfere with assessment of safety and efficacy
- Previous history of seizures or seizure disorders.
- Evidence of clinically significant unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurologic, or metabolic disease within the 6 months prior to enrollment. If there is a history of cancer, the participant should be clear of cancer for at least 2 years prior to screening. More recent history of basal cell or squamous cell carcinoma and melanoma in situ (Stage 0) may be acceptable after review by the Medical Monitor.
- Estimated Glomerular Filtration Rate (eGFR) of <45ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bryostatin 1Eligible 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. | Drug | Bryostatin 1 |
Primary outcome
Adverse Events
Time frame: Approximately 37 weeks
Frequency of Adverse Events [Treatment Emergent AEs (TEAEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARS)]
Study Medication Discontinuation
Time frame: Approximately 37 weeks
Frequency of study medication discontinuation and reason thereof
CNS Inflammatory Effects
Time frame: Approximately 37 weeks
Potential CNS inflammatory effects as captured by clinical monitoring and MRI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Fox, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bryostatin 1 in people with Multiple Sclerosis, run by Robert Fox at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Approximately 37 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.