Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmbros Therapeutics, Inc.
About this trial
Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1
Eligibility criteria
Qualifiers
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.
Edema in the affected limb
Obvious redness in the affected region relative to the same region on the contralateral limb on inspection
Disqualifiers
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.
IV bisphosphonates
Trial design
Treatments tested in this trial
- Neridronate
- Placebo
Treatment groups
270 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov