RecruitingPhase 3

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

United States270 participantsStarted 2026-04

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female participant ≥ 18 years of age at time of Screening.
✓. 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 symptoms of CRPS must apply to a single identified affected limb (i.e., arm, hand, wrist, leg, ankle or foot) and must demonstrate asymmetry with respect to the contralateral limb.
✓. Single affected limb at the Screening and Randomization Visits meeting the following warm subtype criteria:
✓. Edema in the affected limb
✓. AND ≥ 2 of the following:
✓. Obvious redness in the affected region relative to the same region on the contralateral limb on inspection
✓. ≥ 1°C increase in temperature on the affected limb relative to the contralateral limb
✓. Moderate-to-severe edema

✕. A current or prior diagnosis of CRPS Type 2 or CRPS not otherwise specified (CRPS NOS), or whose CRPS has no known inciting event, or CRPS-1 without criteria of the warm subtype at the time of Screening.
✕. ≥ 40 points on the Pain Catastrophizing Scale.
✕. Prior use of neridronate or participation in a clinical study where the participant may have received neridronate.
✕. Participants currently taking or planning to be treated with prohibited concomitant medications/therapies, or not likely able to follow the protocol restrictions for use of concomitant treatment.
✕. Severely impaired renal function.
✕. Hypocalcemia.
✕. Vitamin D deficiency.
✕. Significant dental findings such as an unhealed tooth extraction site.

Change in pain intensity from baseline to Week 12.

Timeframe: Week 12

NCT IDNCT07210515

SponsorAmbros Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

SVP, Clinical Operations

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female participant ≥ 18 years of age at time of Screening.
✓. 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 symptoms of CRPS must apply to a single identified affected limb (i.e., arm, hand, wrist, leg, ankle or foot) and must demonstrate asymmetry with respect to the contralateral limb.
✓. Single affected limb at the Screening and Randomization Visits meeting the following warm subtype criteria:
✓. Edema in the affected limb
✓. AND ≥ 2 of the following:
✓. Obvious redness in the affected region relative to the same region on the contralateral limb on inspection
✓. ≥ 1°C increase in temperature on the affected limb relative to the contralateral limb
✓. Moderate-to-severe edema

✕. A current or prior diagnosis of CRPS Type 2 or CRPS not otherwise specified (CRPS NOS), or whose CRPS has no known inciting event, or CRPS-1 without criteria of the warm subtype at the time of Screening.
✕. ≥ 40 points on the Pain Catastrophizing Scale.
✕. Prior use of neridronate or participation in a clinical study where the participant may have received neridronate.
✕. Participants currently taking or planning to be treated with prohibited concomitant medications/therapies, or not likely able to follow the protocol restrictions for use of concomitant treatment.
✕. Severely impaired renal function.
✕. Hypocalcemia.
✕. Vitamin D deficiency.
✕. Significant dental findings such as an unhealed tooth extraction site.