Efficacy and safety of intravenous neridronic acid in CRPS
Research type
Research Study
Full title
Placebo-controlled efficacy and safety trial of intravenous neridronic acid in subjects with complex regional pain syndrome (CRPS)
IRAS ID
235643
Contact name
Sol Yates
Contact email
Sponsor organisation
Grünenthal GmbH
Eudract number
2016-003833-91
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 10 months, 30 days
Research summary
This is a multi-site, randomised, double-blind, placebo-controlled, 2-arm, Phase III trial of intravenous neridronic acid in subjects with CRPS. Approximately 94 participants who have CRPS will be included in the clinical trial and will be in the clinical trial for about 14 months. The clinical trial has 4 parts for all participants and and additional 5th part for participants still experiencing pain: an Enrolment Period, Treatment Period A, Follow-up Period 1, Treatment period B (for participants still experiencing pain) and Follow-up Period 2. In the enrolment period the following will be performed, a physical examination, record ECG heart rhythm, and take blood and urine samples for testing. If participants are eligible based on the outcome of the Enrolment Period, they will be assigned by chance to 1 of 2 treatment groups: 1) four infusions of neridronic acid or 2) four infusions of placebo. They will have an equal chance to be assigned to either treatment group; neither they nor the trial doctor will know which treatment they receive. In treatment period A the infusions will be given on Day 1, Day 4, Day 7, and Day 10. Follow up period 1, follow-up assessments will be performed at approximately 2 Weeks, 6 Weeks, 12 Weeks, 16 Weeks, and 22 Weeks after the first infusion. Follow up period 2, on Day 183 (Week 26) participants will be reassessed to see if they are eligible for Treatment Period B. Treatment period B eligible participants will receive four infusions of neridronic acid on Day 183, Day 186, Day 189, and Day 192. Follow-up assessments will take place on Day 197 (Week 28). All participants will be asked to return to the trial site for follow-up assessments at approximately 36 Weeks and 52 Weeks after the first infusion.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1092
Date of REC Opinion
10 Aug 2018
REC opinion
Further Information Favourable Opinion