ARTICLE | Clinical News

IDMC recommends discontinuing Phase III of Axsome's AXS-02 for complex regional pain syndrome

January 12, 2018 6:16 PM UTC

Axsome Therapeutics Inc. (NASDAQ:AXSM) said an IDMC recommended discontinuing for futility the Phase III CREATE-1 trial of once-weekly oral AXS-02 (disodium zoledronate tetrahydrate) for six weeks to treat pain associated with complex regional pain syndrome (CRPS) following an interim safety and efficacy analysis in 81 patients.

Axsome did not provide details on the efficacy data that led to the IDMC recommendation, but did say AXS-02 led to a significant reduction in serum collagen type I (COL1), a marker of bone resorption, vs. placebo (p<0.0001). The company said the COL1 data confirm the pharmacologic activity of AXS-02 on bone resorption. AXS-02 was generally well tolerated...