Complex Regional Pain Syndrome Clinical Trial
Official title:
Open-label Safety Trial of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome (CRPS)
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).
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.
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|---|---|---|---|
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