Multiple Sclerosis Clinical Trial

Safety of Bryostatin in Patients With MS

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).

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion

Written informed consent signed by participant
English-speaking
Hospital Anxiety and Depression Scale <11
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.
Processing Speed Test (PST) z-score between -1.0 and -2.5
EDSS between 0.0 and 7.0, inclusive.
Adequate vision and motor function to participate in assessment procedures
Participants must be 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.

Exclusion

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)
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
Routine or intermittent use of benzodiazepines in the last year (rare use in the last year is allowed as long as use during the study is not expected).
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
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 Edition, 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]
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 (PTT >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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT06190912

Recruitment Status:

Recruiting

Sponsor:

Robert Fox

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There is 1 Location for this study

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Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Ariel Bizon
Contact
216-445-9411
[email protected]
Bryan Davies, RN
Contact
216-444-5253
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT06190912

Recruitment Status:

Recruiting

Sponsor:


Robert Fox

How clear is this clinincal trial information?

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