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New treatment option for Complex Regional Pain Syndrome Type I
Official title Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
ClinicalTrials.gov ID: NCT07210515
What this study is testing
What is Neridronate?
Neridronate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for complex regional pain syndrome type i.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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:
You likely can't join if
- 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...
- ≥ 40 points on the Pain Catastrophizing Scale.
- Prior use of neridronate or participation in a clinical study where the participant may have received neridronate.
- The use of any of the following treatments within the timeframe specified from Randomization Visit:
- Within the last 12 months:
- IV bisphosphonates
See the full eligibility 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...
- 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
- ≤ 6 months since the onset of CRPS symptoms relative to the Randomization visit
- 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...
- 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...
- Adequate compliance with the eDiary during the screening period.
- 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.
- The use of any of the following treatments within the timeframe specified from Randomization Visit:
- Within the last 12 months:
- IV bisphosphonates
- IV immunoglobulin
- Within the last 6 months:
- Any oral bisphosphonate, denosumab (Prolia®) or receptor activator of nuclear factor kappa B ligand (RANKL) inhibitors (e.g., denosumab biosimilar compounds)
- Calcitonin
- Ketamine
- Radiation therapy to the head or neck
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Napa, California, United States
- Pasadena, California, United States
- Tustin, California, United States
- Washington D.C., District of Columbia, United States
- Brandon, Florida, United States
- Daytona Beach, Florida, United States
- Pembroke Pines, Florida, United States
- Lawrenceville, Georgia, United States
- Newnan, Georgia, United States
- Chicago, Illinois, United States
- Orland Park, Illinois, United States
- Reno, Nevada, United States
- Shrewsbury, New Jersey, United States
- Charlotte, North Carolina, United States
- Wilmington, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Tucson, Arizona, United States; Napa, California, United States; Pasadena, California, United States; Tustin, California, United States; Washington D.C., District of Columbia, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.