MEMOIR: a clinical trial of memantine and Graded Motor Imagery for Complex Regional Pain Syndrome

Phase 3

Recruiting

• Conditions: Complex Regional Pain Syndrome; Neurological - Other neurological disorders; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12621000175875
• Lead Sponsor: euroscience Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-18
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Diagnosis of unilateral, chronic CRPS according to the Budapest research criteria, of 6–36 months duration; at least moderate pain and disability measured by SF-36 items 7 and 8; English language proficiency; access to internet; willingness to provide informed consent.

Exclusion Criteria

Known allergies to NMDA receptor antagonists; taking more than 40mg/day of morphine equivalents or opioid analgesics; taking methadone; using more than 300mg/day of pregabalin or more than 900mg/day gabapentin; using monoamine oxidase inhibitors; using more than 50mg/day of tricyclic antidepressants; having used ketamine in the preceding 4 weeks; having received lidocaine injections or infusions in the preceding 4 weeks; having used oral bisphosphonate or received bisphosphonate injections in the preceding 4 weeks; taking beta-blocker medications or other medications to manage blood pressure; taking anti-arrhythmic cardiac medications; taking anti-psychotic medications; taking cisapride; taking erythromycin; taking quinolones; taking anti-tuberculous agents; taking anti-fungal agents; taking antiretrovirals; with known moderate to severe renal impairment or risk factors for kidney conditions, including hypertension (BP of 140/90mmHg or greater), diabetes (defined as HbA1c of 6.5% or greater or fasting glucose of 7.0 mmol/L or greater), or a family history of kidney disease; diagnosis of prolonged QTc syndrome; ventricular fibrillation; ventricular tachycardia; heart block; Torsades de Pointes; implanted pacemaker or defibrillator; history of serious neurological conditions (stroke, seizure disorders, Alzheimer’s disease, paralysis); implanted spinal cord or nerve stimulators; females who are pregnant or lactating; females of child-bearing potential and not using reliable contraceptive method(s); males and females planning conception; current use of illicit substances; current use of Graded Motor Imagery; scheduled for major surgery during the treatment or follow-up period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average pain intensity over the previous 7 days, measured using the 11-point Numerical Pain Rating Scale[Week 16 post-randomisation];Pain interference, measured using PROMIS Pain Interference (CAT)[Week 16 post-randomisation]