Clinical trial NCT02504008: CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Complex Regional Pain Syndrome
Reflex Sympathetic Dystrophy
Keywords: bisphosphonate
CRPS
RSD
non-opioid
CRPS-1
acute on chronic pain
chronic pain
zoledronic acid
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-21
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in patient reported pain intensity
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change in Brief Pain Inventory (BPI) Pain Score
timeFrame: Baseline to Week 12
measure: Patients' Global Impression of Change (PGI-C)
timeFrame: Baseline to Week 12
measure: Clinicians' Global Impression of Change (CGI-C)
timeFrame: Baseline to Week 12
measure: Change in EuroQOL 5-dimensions questionnaire (EQ-5D)
timeFrame: Baseline to Week 12
measure: Change in Short-Form McGill Pain Questionnaire (SF-MPQ-2)
timeFrame: Baseline to Week 12
measure: Change in bone turnover markers
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Encinitas
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Napa
country: United States
state: California
city: Temecula
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Clermont
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Canton
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Saint Marys
country: United States
state: Georgia
city: Meridian
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Bellevue
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Broadmeadow
country: Australia
state: New South Wales
city: Hurstville
country: Australia
state: New South Wales
city: Noosa Heads
country: Australia
state: Queensland
city: Welland
country: Australia
state: South Australia
city: Clayton
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Sherbrooke
country: Canada
state: Quebec
city: Warrington
country: United Kingdom
state: Cheshire
city: Darlington
country: United Kingdom
state: County Durham
city: Lambeth
country: United Kingdom
state: London
city: Liverpool
country: United Kingdom
state: Merseyside
city: Norwich
country: United Kingdom
state: Norfolk
city: Newcastle upon Tyne
country: United Kingdom
state: Tyne And Wear
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
Study officials:
References: