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

Axsome Therapeutics

Status and phase: Unknown; Phase 3

Conditions: Reflex Sympathetic Dystrophy; Complex Regional Pain Syndrome

Treatments: Drug: Placebo; Drug: AXS-02 (oral zoledronate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02504008

AXS02-301

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 2 patient groups, including a placebo group

AXS-02 (oral zoledronate)

Experimental group

Description:

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

Treatment:

Drug: AXS-02 (oral zoledronate)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo