NCT02972359

Safety of Intravenous Neridronic Acid in CRPS

Open-label Safety Trial of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome (CRPS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 580 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

At the Enrollment Visit the trial objectives, procedures, and risks were explained to the participants and the informed consent form was signed. Medical history was obtained, a physical examination was conducted, and other safety assessments were performed. Signs and symptoms of CRPS were assessed to confirm the diagnosis of CRPS according to the Budapest clinical criteria. Participants were trained to report their pain. Calcium and vitamin D supplementation were initiated to ensure sufficient vitamin D levels prior to treatment. Participants meeting all eligibility criteria received infusions of investigational medicinal product (IMP) during visits on Day 1, Day 4, Day 7, and Day 10. Flexibility of ±1 day was allowed for Day 4, Day 7, and Day 10 whilst ensuring a minimum period of 48 hours between infusions. During the treatment period and follow-up period, pain intensity ratings were captured at the site visits in a patient reported-outcome system.

Conditions

• Complex Regional Pain Syndrome

Interventions

Type	Name	Description
DRUG	Neridronic acid	Neridronic acid administered as intravenous infusion.

Timeline

• Start date: 2016-12-20
• Primary completion: 2019-01-09
• Completion: 2019-01-09
• First posted: 2016-11-23
• Last updated: 2019-11-21
• Results posted: 2019-11-04

Locations

46 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study