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Ketamine HCl Prolonged Release Oral Tablets for CRPS

NCT06419985 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-01-26

No results posted yet for this study

Summary

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.

Conditions

  • Complex Regional Pain Syndromes

Interventions

DRUG

80mg/day Ketamine HCl Prolonged Release

Administration of Ketamine HCl Prolonged Release - 40mg BID

DRUG

160mg/day Ketamine HCl Prolonged Release

Administration of Ketamine HCl Prolonged Release - 80mg BID

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Steven Richeimer, MD · Keck Medical Center of USC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-01-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06419985 on ClinicalTrials.gov