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NMDA Receptor Antagonist
Ketamine Tablets for Complex Regional Pain Syndrome
Phase 2
Waitlist Available
Led By Steven Richeimer, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female participants between 18 and 70 years of age, inclusive, at Screening Visit
Participants with a documented history of CRPS of at least 6 months at Visit 1
Must not have
Known or suspected cardiovascular disease, arrhythmias, and/or respiratory issues
Known or suspected elevated intraocular and/or intracranial pressure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to 18 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the safety and effectiveness of Ketamine HCl Prolonged Release tablets in people with complex regional pain syndrome. It will also assess how well participants follow the dosing instructions
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, ketamine can commonly cause dizziness, nausea, blurred vision, feelings of detachment from reality or changes in perception. Side effects vary based on dosage and individual response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
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I have had CRPS for at least 6 months.
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I agree to stop taking ketamine 14 days before the study starts.
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My daily pain level in the affected limb averages between 5 and 9.
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My current treatment for CRPS pain has been stable for at least 4 weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have heart or lung problems.
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I might have high pressure in my eyes or brain.
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I have kidney or bladder conditions, or my urine test was abnormal.
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My kidneys are not working well or I am on dialysis.
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I have or might have an overactive thyroid.
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I am not allergic to ketamine or its ingredients.
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I have been taking opioids equivalent to 30 mg/day of morphine for my pain in the last two weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 18 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Plasma concentration [Cmax] of Ketamine
Maximum Tolerated Dose (MTD) of Ketamine HCl PR oral tablets
Safety of Ketamine HCl PR oral tablets
+1 moreSecondary study objectives
Average Daily Pain Numerical Rating Scale (ADP NRS)
Complex Regional Pain Syndrome Severity Scale (CSS)
Medication sparing
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: 80mg Ketamine HCl PRExperimental Treatment1 Intervention
One 40mg tablet of Ketamine HCl PR twice a day
Group II: 240mg Ketamine HCl PRExperimental Treatment1 Intervention
Three 40mg tablets of Ketamine HCl PR twice a day
Group III: 160mg Ketamine HCl PRExperimental Treatment1 Intervention
Two 40mg tablets of Ketamine HCl PR twice a day
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
946 Previous Clinical Trials
1,604,788 Total Patients Enrolled
Steven Richeimer, MDPrincipal InvestigatorKeck Medical Center of USC
1 Previous Clinical Trials
36 Total Patients Enrolled