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Neridronate

Phase 3

Complex Regional Pain Syndrome Type I | Small molecule | Pain |cbdMD, Inc.|Last Updated: Aug 21, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment270

FDA Designations

No designations recorded

Clinical trial landscape

Neridronate · 1 trial · 1 indication

Phase 3 1
NCT07210515Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)Complex Regional Pain Syndrome Type I
RECRUITING270 Analytics
PHASE3RECRUITING
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
NCT07210515270
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Study Endpoints

Primary Endpoints

Change in pain intensity from baseline to Week 12.
Week 12

Assessed on an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 representing the worst possible pain.

Secondary Endpoints

At least a 50% reduction from baseline to Week 12 in pain intensity.
Week 12
Change from baseline in CRPS Severity Score (CSS) to Week 12.
Week 12
Patient Global Impression of Change (PGI-C) in CRPS-Related Health.
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
neridronateEXPERIMENTAL400 mg AMBTX-01 infusion
PlaceboPLACEBO_COMPARATORPlacebo comparator

Interventions

NameTypeDescription
NeridronateDRUGneridronate 100 mg, given as a 2-hour infusion on Days 1, 4, 7, and 10.
PlaceboDRUGplacebo comparator
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: 1. Male or female participant ≥ 18 years of age at time of Screening. 2. A diagnosis of CRPS-1 according to the clinical Budapest Criteria as recommended by the International Association for the Study of Pain (IASP), as well as no known peripheral nerve injury. Signs and symptom...

Countries:United States
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