ZOLEDRONIC ACID, A LONG-ACTING BISPHOSPHONATE, FOR CHRONIC LOW BACK PAIN DUE TO MODIC CHANGES: A RANDOMIZED CONTROLLED TRIAL
Phase of Trial: Phase III
Latest Information Update: 09 May 2017
At a glance
- Drugs Zoledronic acid (Primary)
- Indications Back pain
- Focus Therapeutic Use
- Acronyms ZAMOD
- Sponsors Axsome Therapeutics
- 09 May 2017 According to an Axsome media release, the start of this trial is planned following readouts from ongoing Phase 3 trials in CRPS and TRD (see profile 258879 and 266743 respectively)
- 07 Mar 2017 According to an Axsome Therapeutics media release, in Feb 2017 company received IND clearance from the FDA to proceed this trial. The IND clearance builds upon previously reported positive results from the randomized, double-blind, placebo-controlled Phase 2 trial conducted with intravenous zoledronic acid showing a statistically significant reduction in low back pain intensity and NSAID usage as compared to placebo in patients with CLBP and MCs.
- 24 Mar 2016 According to an Axsome Therapeutics media release, this trial is expected to initiate in the fourth quarter of 2016 or the first quarter of 2017.