Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)

Conditions

• Complex Regional Pain Syndrome Type I

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Neridronate — DRUG
  neridronate 100 mg, given as a 2-hour infusion on Days 1, 4, 7, and 10.
• Placebo — DRUG
  placebo comparator

Study Details

Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1

Key Dates

First listed

Oct 7, 2025

Start date

Apr 14, 2026

Status verified

Aug 2026

Primary completion

Dec 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

270 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: neridronate
  400 mg AMBTX-01 infusion
• Placebo Comparator: Placebo
  Placebo comparator

Primary Outcome Measure

Change in pain intensity from baseline to Week 12. [ Time Frame: Week 12 ]

Central Contacts

• SVP, Clinical Operations
  +1 949-785-4954
  [email protected]
• Ambros Therapeutics, Inc

Locations (24)

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