Ketamine HCl Prolonged Release Oral Tablets for CRPS

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT06419985
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Complex Regional Pain Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • 80mg/day Ketamine HCl Prolonged Release — DRUG
    Administration of Ketamine HCl Prolonged Release - 40mg BID
  • 160mg/day Ketamine HCl Prolonged Release — DRUG
    Administration of Ketamine HCl Prolonged Release - 80mg BID

Study Details

The purpose of this study is to evaluate the efficacy 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 for safety and quality of life measurements, and pharmacokinetic profile.

Key Dates

Start date
Jul 31, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 80mg Ketamine HCl PR
    One 40mg tablet of Ketamine HCl PR twice a day, which may be increased to two 40mg tablets Ketamine HCl PR twice a day at week 4 if subject does not experience adequate pain relief.

Primary Outcome Measure

Average Daily Pain Numerical Rating Scale (ADP NRS) [ Time Frame: Day 1 to week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pain Center, Keck Medical Center of University of Southern CaliforniaLos AngelesCalifornia90033
Steven Richeimer, MD
[email protected]
323-442-6202
Faye Weinstein, PhD
[email protected]
323-442-6202
Steven Richeimer, MD (PRINCIPAL_INVESTIGATOR)
Ashley Balentine, MD (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Pain Center, Keck Medical Center of University of Southern California· Los Angeles, CA

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