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

This study is currently recruiting participants.
Verified October 2017 by Axsome Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02504008
First Posted: July 21, 2015
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.
July 20, 2015
July 21, 2015
October 9, 2017
July 2015
December 2017   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT02504008 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1
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 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Complex Regional Pain Syndrome
  • Reflex Sympathetic Dystrophy
  • Drug: AXS-02 (oral zoledronate)
    Once weekly for 6 weeks
  • Drug: Placebo
    Once weekly for 6 weeks
  • Experimental: AXS-02 (oral zoledronate)
    Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36
    Intervention: Drug: AXS-02 (oral zoledronate)
  • Placebo Comparator: Placebo
    Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
190
Not Provided
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Axsome Clinical Trials CREATE-1@axsome.com
Australia,   Canada,   United Kingdom,   United States
 
 
NCT02504008
AXS02-301
Yes
Not Provided
Not Provided
Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc.
Not Provided
Not Provided
Axsome Therapeutics, Inc.
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP