Clinical Trial TitleA randomized, double-blind, placebo-controlled study to assess the efficacy and safety of AXS-02 (disodium zoledronate tetrahydrate) administered orally to subjects with complex regional pain syndrome type I (CRPS-I).
Clinical Trial Protocol Description:
The study is up to 28 weeks in length, divided into 3 periods: an up to 4 week screening period, a 12-week randomized double-blind period, and a 12-week follow-up period. Subjects who meet all entry criteria will be randomly assigned on day 1 of the baseline period to receive AXS-02 or placebo in a 1:1 ratio (active: placebo) weekly for 6 weeks.
Assessments will include: daily pain score, brief pain inventory, quality of life assessments, bone turnover markers, safety assessments.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a baseline average pain of 5 or greater (numerical rating scale 0-10).
- Have a diagnosis of CRPS within 6 months.
- Have CRPS caused by a traumatic event (eg, fracture, crushing injury, orthopedic surgery) which occurred within less than one year.
- Are not currently receiving opioids.
This is a partial list of elgibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.