Efficacy and Safety of Intravenous Neridronic Acid in CRPS
Summary
The aim of this trial was to investigate the efficacy and safety of intravenous neridronic acid in subjects with Complex Regional Pain Syndrome (CRPS). The trial consisted of an Enrollment Period lasting up to 60 days, Treatment Period A consisting of 4 infusions (neridronic acid or placebo) over 10 days, and a Follow-up Period 1 until Week 26. At Week 26, participants not meeting the pre-specified criteria to continue into Treatment Period B continued in Follow-up Period 2 until Week 52. Participants meeting the pre-specified criteria entered the open-label Treatment Period B with 4 additional infusions (neridronic acid) over 10 days and follow-up visits until Week 52.
Timeline
- Start
- 2018-05-30
- Primary completion
- 2019-07-31
- Completion
- 2019-07-31
Outcome
Met primary endpoint
Stopped (Business): “Sponsor decision”
registry analysis (superiority test); Neridronic Acid - Treatment Period A vs Placebo - Treatment Period A; p = 0.0111; Mean Difference (Net) -1.07 (95% CI -1.89 to -0.26) NCT03530345 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Neridronic acid | Unknown | 100 mg | Intravenous |