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

Complex Regional Pain Syndrome Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02504008
• Other study ID #: AXS02-301
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 20, 2015
• Last updated: March 21, 2018
• Start date: July 2015
• Est. completion date: January 2019

Study information

• Verified date: March 2018
• Source: Axsome Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Syndrome

Intervention

Drug:
• AXS-02 (oral zoledronate)
Once weekly for 6 weeks
• Placebo
Once weekly for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Axsome Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline to Week 12
Secondary	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.	Baseline to Week 12
Secondary	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.	Baseline to Week 12
Secondary	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.	Baseline to Week 12
Secondary	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).	Baseline to Week 12
Secondary	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.	Baseline to Week 12
Secondary	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).	Baseline to Week 52

External Links

•   Click here to learn more and see if you qualify.