NCT02504008 - CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1 | Crick | Crick

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

Phase 3UnknownNCT02504008

Axsome Therapeutics, Inc.190 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

190

Conditions

Complex Regional Pain Syndrome Reflex Sympathetic Dystrophy

Interventions

AXS-02 (oral zoledronate)DRUG

Once weekly for 6 weeks

Once weekly for 6 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (44)

Outcomes

Primary Outcomes

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).

Time frame: Baseline to Week 12

Secondary Outcomes

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.

Time frame: Baseline to Week 12

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.

Time frame: Baseline to Week 12

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.

Time frame: Baseline to Week 12

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).

Time frame: Baseline to Week 12

Change in Short-Form McGill Pain Questionnaire (SF-MPQ-2)

Data from ClinicalTrials.gov

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