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

Primary Purpose

Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AXS-02 (oral zoledronate)
Placebo
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndrome focused on measuring bisphosphonate, CRPS, RSD, non-opioid, CRPS-1, acute on chronic pain, chronic pain, zoledronic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AXS-02 (oral zoledronate)

Placebo

Arm Description

Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36

Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36

Outcomes

Primary Outcome Measures

Change in patient reported pain intensity
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
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)
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)
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)
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)
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
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).

Full Information

First Posted
July 20, 2015
Last Updated
March 21, 2018
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02504008
Brief Title
CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1
Acronym
CREATE-1
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axsome Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy
Keywords
bisphosphonate, CRPS, RSD, non-opioid, CRPS-1, acute on chronic pain, chronic pain, zoledronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AXS-02 (oral zoledronate)
Arm Type
Experimental
Arm Description
Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36
Intervention Type
Drug
Intervention Name(s)
AXS-02 (oral zoledronate)
Intervention Description
Once weekly for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once weekly for 6 weeks
Primary Outcome Measure Information:
Title
Change in patient reported pain intensity
Description
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).
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change in Brief Pain Inventory (BPI) Pain Score
Description
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.
Time Frame
Baseline to Week 12
Title
Patients' Global Impression of Change (PGI-C)
Description
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.
Time Frame
Baseline to Week 12
Title
Clinicians' Global Impression of Change (CGI-C)
Description
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.
Time Frame
Baseline to Week 12
Title
Change in EuroQOL 5-dimensions questionnaire (EQ-5D)
Description
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).
Time Frame
Baseline to Week 12
Title
Change in Short-Form McGill Pain Questionnaire (SF-MPQ-2)
Description
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.
Time Frame
Baseline to Week 12
Title
Change in bone turnover markers
Description
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).
Time Frame
Baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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12. IPD Sharing Statement

Learn more about this trial

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

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