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CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1

NCT02504008 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2018-03-23

No results posted yet for this study

Summary

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.

Conditions

  • Complex Regional Pain Syndrome
  • Reflex Sympathetic Dystrophy

Interventions

DRUG

AXS-02 (oral zoledronate)

Once weekly for 6 weeks

DRUG

Placebo

Once weekly for 6 weeks

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States
  • Australia
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02504008 on ClinicalTrials.gov