Efficacy and safety of intravenous neridronic acid in CRPSI
Research type
Research Study
Full title
A randomized, double-blind trial investigating the efficacy and safety of intravenous neridronic acid in subjects with complex regional pain syndrome type I (CRPS-I)
IRAS ID
165195
Contact name
Nicholas Shenker
Contact email
Sponsor organisation
Grünenthal GmbH
Eudract number
2014-001915-37
Duration of Study in the UK
0 years, 11 months, 29 days
Research summary
Complex regional pain syndrome type I (CRPS-I) is a rare, chronic, and disabling pain syndrome that can develop after an injury. There are currently no approved pharmacological treatments for pain associated with CRPS-I and patients are underserved due to a poor understanding of the condition and use of ineffective treatments.
Grünenthal is investigating intravenous neridronic acid (an experimental medicine, which means it has not been approved by the drug approval agency) as a treatment of pain associated with CRPS-I based on the results of a recently completed multi-site, placebo-controlled trial. These results demonstrated a statistically significant difference in the percentage of participants with at least 50% decrease in pain intensity. The results suggest intravenous neridronic acid is effective and safe for treatment of pain associated with CRPS-I. Therefore this study is intended to further investigate the efficacy and safety of neridronic acid in the treatment of pain associated with CRPS-I, versus placebo.
This is a randomized, placebo-controlled, 3-arm parallel-group study in which participants will receive a single 10-day treatment course and follow-up assessments for up to 1 year. Use of a placebo control is considered justifiable when there are no established effective treatments CRPS-I. Standard care will be given to all groups.
Approximately 225 patients, who have CRPS-I, will be included in this study, and will participate in the trial for up to 13 months.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0238
Date of REC Opinion
28 Aug 2015
REC opinion
Further Information Favourable Opinion