Status:
NOT_YET_RECRUITING
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Lead Sponsor:
Ambros Therapeutics, Inc.
Conditions:
Complex Regional Pain Syndrome Type I
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1
Detailed Description
This is a multicenter, randomized, triple-blind, controlled trial, to assess the efficacy, safety, and tolerability of neridronate 400 mg IV in adult participants with the warm subtype of Complex Regi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- CRPS symptoms ≤ 6 months since onset.
- Increased uptake in the involved limb compared to the contralateral limb on TPBS (phase 2 and/or phase 3) during Screening. A historic scan not older than 3 months prior to Randomization Visit is acceptable, if available and of sufficient quality for a central read.
- "Pain now" assessments of \> 4 on the 11 point numerical rating scale in the CRPS affected limb.
- Women of childbearing potential must:
- Be nonpregnant.
- Be nonlactating.
- Agree to use a highly effective method of contraception and for at least 6 months following last investigational product administration.
- Exception: Women exclusively engaging in same sex sexual activities are not required to meet this criterion.
- Exclusion Criteria
- 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.
- Eye inflammation.
- Significantly elevated liver-related lab tests or evidence of significant liver disease.
- Clinically unstable cardiac disease.
- Any known conditions, from 3 months prior to Screening Visit or to the Randomization Visit, that may interfere with the assessment of CRPS-1, CRPS-related pain, safety, or other trial assessments.
Exclusion
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT07210515
Start Date
March 1 2026
End Date
January 1 2028
Last Update
October 7 2025
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