Ketamine HCl Prolonged Release Oral Tablets for CRPS
Open-label, single-group Phase II study (n=65) evaluating safety, tolerability, and pharmacokinetics of Ketamine HCl PR tablets (start 40 mg BID; may increase to 80 mg BID) in adults with CRPS-related pain.
Details
This single-group Phase II trial will evaluate Ketamine HCl Prolonged Release tablets for treatment of pain due to complex regional pain syndrome (CRPS) and assess feasibility measures including dosing compliance and pharmacokinetics.
Participants start 40 mg twice daily (80 mg/day) at baseline with in-clinic observation for 6 hours after the first dose; dose may be increased to 80 mg twice daily (160 mg/day) at week 4 if inadequate pain relief and no safety concerns.
Safety assessments include vitals, EKG, labs, KSET forms, and AE monitoring; efficacy and QoL assessed via daily pain diaries and questionnaires across ten clinic and telemedicine visits with follow-up after end of treatment.