Complex Regional Pain Syndrome Type I study: Neridronate
Official title Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
ClinicalTrials.gov ID: NCT07857733
What this study is testing
What is Neridronate?
An investigational intravenous medicine being studied 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
- The study aims to evaluate the safety and effectiveness of neridronate in patients with Complex Regional Pain Syndrome Type I.
- Who it's for
- Adults diagnosed with Complex Regional Pain Syndrome Type I.
- What's involved
- Participants receive neridronate and are monitored for safety and effectiveness.
- 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
- Participants must have completed the Week 12 visit of the neridronate AMBTX-01-301 assigned by chance Clinical Trial (RCT).
- Both the Investigator and participant must agree that the participant is reasonably likely to benefit from neridronate therapy without undue risk...
- The Investigator must characterize the participants CRPS-1 as a serious condition based on the presence of persistent moderate-to-severe pain or/and...
- Participants must be capable of understanding the study requirements and willing to provide informed consent prior to any study-related procedures.
- Participants must be willing and able to comply with the scheduled treatment plan including 4 infusion visits and safety-related assessments.
You likely can't join if
- Individuals who did not participate in AMBTX-01-301 RCT, or those participants from AMBTX-01-301 RCT who discontinued investigational product and/or...
- Evidence of severely impaired renal function .
- Prior or planned renal transplant.
- Within the last 12 months - IV immunoglobulin, any IV bisphosphonates (excluding investigational product as part of AMBTX-01-301 RCT prior to...
- Within the last 6 months: Any oral bisphosphonate, denosumab (Prolia®) or receptor activator of nuclear factor kappa B ligand (RANKL) inhibitors...
- Within the last 3 months: Cinacalcet, Monoclonal antibody peptides against calcitonin gene-related peptide (CGRP), spinal cord stimulation...
See the full eligibility criteria
- Participants must have completed the Week 12 visit of the neridronate AMBTX-01-301 assigned by chance Clinical Trial (RCT).
- Both the Investigator and participant must agree that the participant is reasonably likely to benefit from neridronate therapy without undue risk based on information about benefits/risks in the IB.
- The Investigator must characterize the participants CRPS-1 as a serious condition based on the presence of persistent moderate-to-severe pain or/and persistent moderate-to-severe CRPS-1 signs or/and symptoms other than...
- Participants must be capable of understanding the study requirements and willing to provide informed consent prior to any study-related procedures.
- Participants must be willing and able to comply with the scheduled treatment plan including 4 infusion visits and safety-related assessments.
- Participants must have adequate venous access to enable blood sampling and 4 IV infusions.
- Be nonpregnant as determined by a negative highly sensitive urine pregnancy test on every visit before neridronate administration.
- Be nonlactating.
- Agree to use a highly effective method of contraception from at least 28 days prior to treatment for oral contraception (or at least 1 week longer than specified by the manufacturer for other contraceptives) and for at...
- Individuals who did not participate in AMBTX-01-301 RCT, or those participants from AMBTX-01-301 RCT who discontinued investigational product and/or were withdrawn from the trial.
- Evidence of severely impaired renal function .
- Prior or planned renal transplant.
- Within the last 12 months - IV immunoglobulin, any IV bisphosphonates (excluding investigational product as part of AMBTX-01-301 RCT prior to open-label treatment);
- 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...
- Within the last 3 months: Cinacalcet, Monoclonal antibody peptides against calcitonin gene-related peptide (CGRP), spinal cord stimulation, radiofrequency ablation, peripheral nerve stimulation and other procedural...
- Within the last 1 month - Any systemic corticosteroid (intranasal, inhaled, or topical corticosteroids are acceptable)
- Within 2 weeks - Lidocaine infusion, somatic or sympathetic nerve blocks, acupuncture, electromagnetic field treatment, scrambler therapy, dorsal root ganglia (DRG) block, initiation or implementation of radiofrequency...
- Hypocalcemia, or high risk for hypocalcemia
- Vitamin D deficiency
- Serum potassium or magnesium outside of the laboratory's reference range at Screening
- Elevated liver-related lab tests or evidence of significant liver disease
- Significant dental findings.
- Eye inflammation
- Clinically unstable cardiac disease
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, 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, but 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?
This study is enrolling now at Phoenix, Arizona, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.