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CST-3056

Phase 2

Neurogenic Orthostatic Hypotension | Small molecule | Neurology |cbdMD, Inc.|Last Updated: Aug 28, 2026

Success Probability

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Market & Valuation

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Trial Design

PLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

CST-3056 · 1 trial · 1 indication

Phase 2 1
NCT07089043A Study in Subjects With Neurogenic Orthostatic HypotensionNeurogenic Orthostatic Hypotension
ACTIVE NOT_RECRUITING12 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study in Subjects With Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
NCT0708904312
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Study Endpoints

Primary Endpoints

Change from Baseline in Standing Systolic Blood Pressure
Baseline and 1, 2, 3, and 4 hours post-dose on Days 1 to 4

Baseline is defined as the pre-dose measurement on Day 1

Secondary Endpoints

Change from Baseline in Seated Systolic Blood Pressure relative to placebo
Baseline and 5 minutes post-dose on Days 1 to 4
Change from Baseline in the Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 relative to placebo
Baseline and 3 hours post-dose on Days 1 to 4
Change from Baseline in the heads-up tilt table test (HUTT)
Baseline and 3 hours post-dose on Optimal Dose Day (Day 5)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingSINGLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CST-3056EXPERIMENTALSubjects will receive single doses of CST-3056 over 3 days and on the Optimal Dose Day (Day 5)
PlaceboPLACEBO_COMPARATORSubjects will receive a single dose of placebo on 1 day

Interventions

NameTypeDescription
CST-3056DRUGAdministered as an oral solution
PlaceboDRUGAdministered as an oral solution
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Male or female subjects ≥ 18 and ≤ 85 years of age, at time of informed consent. 2. Diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease or pure autonomic failure (i.e. neurogenic orthostatic hypotension). 3. At Screening, subjects must meet the diagn...

Countries:United States
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