CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 580 enrolled
Drug / intervention
Neridronic aciddrug
Likely dose
Neridronic acid administered as intravenous infusion (specific dose not stated in protocol sections provided)AI-extracted
Key inclusion· 5
  • ✓Diagnosis of CRPS according to International Association for the Study of Pain (IASP) Budapest clinical criteria with signs and symptoms in an affected limb demonstrating asymmetry with respect to the contralateral limb
  • ✓Baseline current pain intensity ≥4 on 11-point Numerical Rating Scale in the CRPS-affected limb at Visit 2 (prior to dosing)
  • ✓Stable CRPS treatment and follow-up therapy for at least 1 month prior to treatment allocation
  • ✓Prior failure of at least 2 treatments for CRPS, one of which must be pharmacologic
Key exclusion· 10
  • ✕Renal impairment: eGFR <60 mL/min/1.73 m² or urinary albumin-creatinine ratio >150 mg/g, or history of chronic kidney disease
  • ✕Serum calcium or magnesium outside reference range, history of hypocalcemia, metabolic disorder increasing hypocalcemia risk (e.g., hypoparathyroidism), or concomitant use of drugs causing hypocalcemia (e.g., aminoglycosides)
  • ✕Vitamin D deficiency: 25(OH)D <30 ng/mL prior to treatment allocation
  • ✕Corrected QT interval (QTcF) >470 ms, serum potassium outside reference range, clinically unstable cardiac disease, or risk factors for torsade de pointes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02972359
NCT02972359Phase 3Completed
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Open-label Safety Trial of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome (CRPS)

Grünenthal GmbH·interventional·Posted Nov 23, 2016·Updated Nov 21, 2019

In Brief

A Phase 3 clinical trial evaluating Neridronic acid for Complex Regional Pain Syndrome. Completed, enrolled 580 participants across 46 sites in 2 countries.

Detailed Summary

The aim of this trial was to investigate the safety of intravenous neridronic acid in patients with complex regional pain syndrome (CRPS). The trial was divided into 3 periods: a 60-day enrollment period, a treatment period consisting of 4 infusions over 10 days, and a follow-up period of approximately 50 weeks (with visits at Week 2, Week 6, Week 12, Week 26, Week 39, and Week 52).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplex Regional Pain Syndrome
CountriesGermany, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 23, 2016
Enrollment StartDec 20, 2016
Primary CompletionJan 9, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.6 years ago

Interventions

Neridronic aciddrug

Neridronic acid administered as intravenous infusion.