Trial Outcomes & Findings for Safety of Bryostatin in Patients With MS (NCT NCT06190912)
NCT ID: NCT06190912
Last Updated: 2026-03-31
Results Overview
Frequency of Adverse Events \[Treatment Emergent AEs (TEAEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARS)\]
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
4 participants
Primary outcome timeframe
Approximately 37 weeks
Results posted on
2026-03-31
Participant Flow
Participant milestones
| Measure |
Bryostatin 1
Participants in this arm will receive treatment with Bryostatin 1
Bryostatin 1: 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.
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|---|---|
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Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Bryostatin 1
Participants in this arm will receive treatment with Bryostatin 1
Bryostatin 1: 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.
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|---|---|
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Overall Study
Synaptogenix, Inc, decided to withdraw funding partway through enrollment, on December 12, 2024.
|
4
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Baseline Characteristics
Safety of Bryostatin in Patients With MS
Baseline characteristics by cohort
| Measure |
Bryostatin 1
n=4 Participants
Participants in this arm will receive treatment with Bryostatin 1
Bryostatin 1: 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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=4 Participants
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|
Age, Categorical
Between 18 and 65 years
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4 Participants
n=4 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=4 Participants
|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 5.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
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Region of Enrollment
United States
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4 participants
n=4 Participants
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PRIMARY outcome
Timeframe: Approximately 37 weeksPopulation: 4 participants were analyzed.
Frequency of Adverse Events \[Treatment Emergent AEs (TEAEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARS)\]
Outcome measures
| Measure |
Bryostatin 1
n=4 Participants
Participants in this arm will receive treatment with Bryostatin 1
Bryostatin 1: 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.
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|---|---|
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Adverse Events
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8 adverse events
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PRIMARY outcome
Timeframe: Approximately 37 weeksPopulation: The study medication for one participant was stopped because she moved out of the county; study medication for each of the other three participants was discontinued only because of early termination of the study. No discontinuation occurred as a result of adverse events.
Frequency of study medication discontinuation and reason thereof
Outcome measures
| Measure |
Bryostatin 1
n=4 Participants
Participants in this arm will receive treatment with Bryostatin 1
Bryostatin 1: 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.
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|---|---|
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Study Medication Discontinuation
Discontinuation due to study termination
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3 participants
|
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Study Medication Discontinuation
Discontinuation due to adverse events
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0 participants
|
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Study Medication Discontinuation
Discontinuation due to leaving country
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1 participants
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PRIMARY outcome
Timeframe: Approximately 37 weeksPotential CNS inflammatory effects as captured by clinical monitoring and MRI
Outcome measures
| Measure |
Bryostatin 1
n=4 Participants
Participants in this arm will receive treatment with Bryostatin 1
Bryostatin 1: 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.
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|---|---|
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CNS Inflammatory Effects
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0 CNS inflammatory events
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Adverse Events
Bryostatin 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bryostatin 1
n=4 participants at risk
Participants in this arm will receive treatment with Bryostatin 1
Bryostatin 1: 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.
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|---|---|
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Nervous system disorders
HEADACHE
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25.0%
1/4 • Approximately 37 weeks
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Gastrointestinal disorders
WORSENING DIARRHEA
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25.0%
1/4 • Approximately 37 weeks
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Vascular disorders
FACIAL FLUSHING
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25.0%
1/4 • Approximately 37 weeks
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Injury, poisoning and procedural complications
FRACTURE OF LEFT 5TH TOE
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25.0%
1/4 • Approximately 37 weeks
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Musculoskeletal and connective tissue disorders
UPPER BACK PAIN
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25.0%
1/4 • Approximately 37 weeks
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General disorders
FEVER
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25.0%
1/4 • Approximately 37 weeks
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Infections and infestations
UPPER RESPIRATORY INFECTION
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25.0%
1/4 • Approximately 37 weeks
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Nervous system disorders
SYNCOPE
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25.0%
1/4 • Approximately 37 weeks
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place