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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.
See Contacts and Locations
Verified May 2017 by Axsome Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02504008
First received: July 20, 2015
Last updated: May 23, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Complex Regional Pain Syndrome Reflex Sympathetic Dystrophy Drug: AXS-02 (oral zoledronate) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 With Complex Regional Pain Syndrome Type I (CRPS-I)

Resource links provided by NLM:


Further study details as provided by Axsome Therapeutics, Inc.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 190
Study Start Date: July 2015
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AXS-02 (oral zoledronate)
Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36
Drug: AXS-02 (oral zoledronate)
Once weekly for 6 weeks
Placebo Comparator: Placebo
Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36
Drug: Placebo
Once weekly for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02504008

Contacts
Contact: Axsome Clinical Trials CREATE-1@axsome.com

  Show 44 Study Locations
Sponsors and Collaborators
Axsome Therapeutics, Inc.
  More Information

Additional Information:
Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02504008     History of Changes
Other Study ID Numbers: AXS02-301
Study First Received: July 20, 2015
Last Updated: May 23, 2017

Keywords provided by Axsome Therapeutics, Inc.:
bisphosphonate
CRPS
RSD
non-opioid
CRPS-1
acute on chronic pain
chronic pain
zoledronic acid

Additional relevant MeSH terms:
Syndrome
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Disease
Pathologic Processes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 20, 2017