Clinical Trial Details


Research Study Summary

CREATE-1 Study: CRPS Treatment Evaluation 1 Study. A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-02 (Oral Zolendronate) Administered Orally to Subjects With Complex Regional Pain Syndrome Type I (CRPS-I)


This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in patients with CRPS-I.

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CW ID: 209807
Date Last Changed: February 15, 2017

Clinical Trial Snapshot

Both Male and Female
18 and up
Overall Status
Lead Sponsor
Axsome Therapeutics, Inc.
12 Weeks
Facility Type


Key Inclusion Criteria:

  • Male or female of at least 18 years of age
  • Recently confirmed diagnosis of CRPS-1 (Budapest criteria)
  • Average pain intensity score of ≥ 5 (based on an 11-point scale [0 - 10])
  • Willing and able to provide written informed consent

Key Exclusion Criteria:

  • Received chronic opioid therapy within 4 weeks
  • Received a sympathetic nerve block within 3 weeks
  • Active litigation or a pending workers' compensation decision
  • Any other clinically significant medical or pain condition (eg, Parkinson's disease, cognitive impairment, or fibromyalgia) or clinical laboratory abnormality that would in the investigator's judgment interfere with the subject's ability to participate in the study

More Info

Protocol Number: AXS02-301


Brittany Harvey
University of South Florida- Morsani Center for Advanced Healthcare
13330 USF Laurel Drive
Tampa, FL 33613
Phone: 813-974-9413

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