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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Zoledronate) Administered Orally to Subjects W

Brief 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.

Detailed Summary:
Sponsor: Axsome Therapeutics, Inc.

Current Primary Outcome: Change in patient reported pain intensity [ Time Frame: Baseline to Week 12 ]

Patient reported pain intensity is recorded as an average daily pain intensity using an 11-point scale (0 = no pain to 10 = worst pain possible).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Brief Pain Inventory (BPI) Pain Score [ Time Frame: Baseline to Week 12 ]
    The BPI is a nine-question survey completed by the patient that assesses quality of life and health status. BPI scores range from 0 to 10, with higher values indicating greater pain.
  • Patients' Global Impression of Change (PGI-C) [ Time Frame: Baseline to Week 12 ]
    The PGI-C is a patient/patient's caregiver rated scale to assess the patients overall treatment response. PGI-C is a 7-point (1-7) scale rated as; very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
  • Clinicians' Global Impression of Change (CGI-C) [ Time Frame: Baseline to Week 12 ]
    The CGI-C is an investigator-rated scale to assess the overall treatment response. CGI-C is a 7-point (1-7) scale rated as; very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
  • Change in EuroQOL 5-dimensions questionnaire (EQ-5D) [ Time Frame: Baseline to Week 12 ]
    The EQ-5D descriptive system comprised the following 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated by the patient at one of 5 levels, with level 1 indicating the best health state (no problems) and level 5 indicating worst health state (e.g., unable to walk about).
  • Change in Short-Form McGill Pain Questionnaire (SF-MPQ-2) [ Time Frame: Baseline to Week 12 ]
    The SF-MPQ-2 measures both neuropathic and nonneuropathic pain. It contains a total of 22 descriptors, which are rated on an intensity scale of 0 = None, to 10 = Worst Possible.
  • Change in bone turnover markers [ Time Frame: Baseline to Week 12 ]
    Bone turnover is measured from 2 biomarkers collected from peripheral blood samples: serum carboxy terminal telopeptide of collagen type I (CTX) and serum procollagen type I N terminal propeptide (s-P1NP).


Original Secondary Outcome: Same as current

Information By: Axsome Therapeutics, Inc.

Dates:
Date Received: July 20, 2015
Date Started: July 2015
Date Completion:
Last Updated: September 19, 2016
Last Verified: September 2016