Ketamine Tablets for Complex Regional Pain Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Steven Richeimer, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of Ketamine HCl Prolonged Release (PR) tablets in participants with pain due to complex regional pain syndrome (CRPS). Additionally, this trial will explore the feasibility of the trial design through dosing compliance, clinical instruments, and efficacy signals.

Eligibility Criteria

This trial is for individuals experiencing pain from Complex Regional Pain Syndrome (CRPS). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of CRPS.

Inclusion Criteria

For persons of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of study intervention administration

I agree to stop taking certain medications 14 days before the study starts and during it.

I am between 18 and 70 years old.

Exclusion Criteria

I have heart or lung problems.

Positive urine screen for any of the following: cocaine, amphetamine, methamphetamine, PCP, opioids, THC (other than medication used for individual standard treatment of pain) at Visit 1

Abnormal EKG results, abnormal blood pressure and/or heart rates

Participant Groups

The study is testing the safety and how well the body handles Ketamine HCl Prolonged Release tablets at different strengths: 80mg, 160mg, and 240mg. It will also check if these doses can help manage CRPS pain effectively.

Group I: 80mg Ketamine HCl PR Experimental Treatment 1 Intervention

One 40mg tablet of Ketamine HCl PR twice a day

Group II: 240mg Ketamine HCl PR Experimental Treatment 1 Intervention

Three 40mg tablets of Ketamine HCl PR twice a day

Group III: 160mg Ketamine HCl PR Experimental Treatment 1 Intervention

Two 40mg tablets of Ketamine HCl PR twice a day

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Pain Center, Keck Medical Center of University of Southern California Los Angeles, CA

Who Is Running the Clinical Trial?

University of Southern California Lead Sponsor

References