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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02504008




Registration number
NCT02504008
Ethics application status
Date submitted
20/07/2015
Date registered
21/07/2015
Date last updated
23/03/2018

Titles & IDs
Public title
CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1
Scientific 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)
Secondary ID [1] 0 0
AXS02-301
Universal Trial Number (UTN)
Trial acronym
CREATE-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complex Regional Pain Syndrome 0 0
Reflex Sympathetic Dystrophy 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AXS-02 (oral zoledronate)
Treatment: Drugs - Placebo

Experimental: AXS-02 (oral zoledronate) - Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36

Placebo Comparator: Placebo - Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36


Treatment: Drugs: AXS-02 (oral zoledronate)
Once weekly for 6 weeks

Treatment: Drugs: Placebo
Once weekly for 6 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
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).
Timepoint [4] 0 0
Baseline to Week 12
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline to Week 12
Secondary outcome [6] 0 0
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).
Timepoint [6] 0 0
Baseline to Week 52

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Broadmeadow
Recruitment hospital [2] 0 0
- Hurstville
Recruitment hospital [3] 0 0
- Noosa Heads
Recruitment hospital [4] 0 0
- Welland
Recruitment hospital [5] 0 0
- Clayton
Recruitment hospital [6] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
- Broadmeadow
Recruitment postcode(s) [2] 0 0
- Hurstville
Recruitment postcode(s) [3] 0 0
- Noosa Heads
Recruitment postcode(s) [4] 0 0
- Welland
Recruitment postcode(s) [5] 0 0
- Clayton
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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Florida
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Georgia
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Idaho
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United States of America
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Illinois
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Kentucky
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United States of America
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New Mexico
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New York
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North Carolina
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Oklahoma
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United States of America
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Oregon
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Texas
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United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Cheshire
Country [20] 0 0
United Kingdom
State/province [20] 0 0
County Durham
Country [21] 0 0
United Kingdom
State/province [21] 0 0
London
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Merseyside
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Norfolk
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Tyne And Wear
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Axsome Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02504008
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications