RecruitingComplex Regional Pain Syndrome Type I

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

Eligible age

18+ yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

See if you qualify for this study

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

Sponsor: Ambros Therapeutics, Inc.

✓ 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 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.
✓ 3. Single affected limb at the Screening and Randomization Visits meeting the following warm subtype criteria:
✓ 1. Edema in the affected limb
✓ 2. AND ≥ 2 of the following:
✓ 1. Obvious redness in the affected region relative to the same region on the contralateral limb on inspection
✓ 2. ≥ 1°C increase in temperature on the affected limb relative to the contralateral limb
✓ 3. Moderate-to-severe edema

✕ 1. 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.
✕ 2. ≥ 40 points on the Pain Catastrophizing Scale.
✕ 3. Prior use of neridronate or participation in a clinical study where the participant may have received neridronate.
✕ 4. The use of any of the following treatments within the timeframe specified from Randomization Visit:
✕ 1. Within the last 12 months:
✕ IV bisphosphonates
✕ IV immunoglobulin
✕ 2. Within the last 6 months: