Pivotal phase 3 trial of neridronate in Complex Regional Pain Syndrome Type 1: CRPS-RISE study design and methodology

Thursday, November 13, 2025

9:19 AM - 9:27 AM CT

Location: 301 - 302

Introduction:

Complex Regional Pain Syndrome Type-1 (CRPS-1) is a rare, chronic, and often disabling condition, with no FDA-approved medicines and few therapies demonstrating efficacy in rigorous trials.¹ Neridronate, approved for treatment of CRPS in Italy, is an alkyl-aminobisphosphonate considered to impact CRPS-1 via multiple mechanisms.^2,3 Neridronate’s proposed mechanisms of action and analyses of prior studies^4,5 support a precision medicine approach for including people most likely to respond to neridronate in the phase 3 trial, CRPS-RISE.

Presenting Author(s)

SR

Srinivasa Raja, MD

Director of Research, Division of Pain Medicine
Johns Hopkins Medicine, United States

Co-Author(s)

MR

Michael Rowbotham, MD

Adjunct Professor of Anesthesia; Professor Emeritus of Neurology; Attending Neurologist
UCSF, United States
GC

Gail Cawkwell, MD, PhD

Chief Medical Officer
Ambros Therapeutics, Inc, United States

Submitting Author(s)

AR

Amarita S. Randhawa, PharmD

VP, Medical Affairs
Ambros Therapeutics, Inc
New City, New York, United States

Co-Author(s)

MS

Monica Salamea, n/a

SVP, Clinical Operations
Ambros Therapeutics, Inc, United States
SB

Stephen Bruehl, PhD

Professor
Vanderbilt University Medical Center, United States