NCT03530345

Efficacy and Safety of Intravenous Neridronic Acid in CRPS

Randomized, Double-blind, Placebo-controlled Trial Investigating the Efficacy and Safety of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome (CRPS)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complex Regional Pain Syndrome (CRPS)

Interventions

Type	Name	Description
DRUG	Neridronic acid 100 mg	100 mg neridronic acid supplied in glass vials in 8 mL of excipients.
DRUG	Placebo	Glass vials with matching placebo.

Timeline

• Start date: 2018-05-30
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2018-05-21
• Last updated: 2020-08-06
• Results posted: 2020-08-06

Locations

71 sites across 7 countries: United States, Australia, France, Germany, New Zealand, South Korea, Spain

Regulatory

• FDA-regulated drug study