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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02504008
Recruitment Status : Active, not recruiting
First Posted : July 21, 2015
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 20, 2015
First Posted Date  ICMJE July 21, 2015
Last Update Posted Date March 23, 2018
Actual Study Start Date  ICMJE July 2015
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
  • 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 52 ]
    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 Measures  ICMJE
 (submitted: July 20, 2015)
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1
Official Title  ICMJE 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)
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Complex Regional Pain Syndrome
  • Reflex Sympathetic Dystrophy
Intervention  ICMJE
  • Drug: AXS-02 (oral zoledronate)
    Once weekly for 6 weeks
  • Drug: Placebo
    Once weekly for 6 weeks
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 20, 2015)
190
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02504008
Other Study ID Numbers  ICMJE AXS02-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Axsome Therapeutics, Inc.
Study Sponsor  ICMJE Axsome Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Axsome Therapeutics, Inc.
Verification Date March 2018

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