Ketamine HCl Prolonged Release Oral Tablets for CRPS

NCT06419985 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 23015-0001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CRPS

Outcome Measures

Primary Outcomes (1)

• Average Daily Pain Numerical Rating Scale (ADP NRS)

  Average Daily Pain Numerical Rating Scale is a validated, self-reported instrument used to assess average pain intensity level over the past 24 hours. It uses an 11-point (0-10) scale, with 0 being "no pain" and 10 being "worst pain imaginable."

  Day 1 to week 12

Secondary Outcomes (8)

• Patient-Reported Outcomes Measurement Information System-2 (PROMIS-29 Profile v2.1)

  Day 1 to week 12

• Complex Regional Pain Syndrome Severity Scale (CSS)

  Day 1 to week 12

• Patient Global Impression of Change (PGIC)

  Day 1 to week 12

• Maximum Plasma concentration [Cmax] of Ketamine

  Day 1 to Day 7

• Time to Maximum Plasma concentration [Tmax] of Ketamine

  Day 1 to Day 7

Study Arms (1)

80mg Ketamine HCl PR

EXPERIMENTAL

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.

Drug: 80mg/day Ketamine HCl Prolonged Release; Drug: 160mg/day Ketamine HCl Prolonged Release

Interventions

80mg/day Ketamine HCl Prolonged Release DRUG

Administration of Ketamine HCl Prolonged Release - 40mg BID

Also known as: 80mg Ketamine PR

80mg Ketamine HCl PR

160mg/day Ketamine HCl Prolonged Release DRUG

Administration of Ketamine HCl Prolonged Release - 80mg BID

Also known as: 160mg Ketamine PR

80mg Ketamine HCl PR

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants between 18 and 64 years of age, inclusive, at Screening Visit.
• Participants with a documented history of CRPS of at least 6 months at Visit 1.
• At least one sign in two of the categories of The Budapest Criteria for CRPS to support the diagnosis of CRPS.
• Stable individual regular standard treatment regimen for CRPS pain, i.e., no change in drug and non-drug treatments for at least 4 weeks prior to Screening Visit and anticipated to remain stable throughout the study.
• No surgery, denervation procedures or neural blockade within 1 month of Screening Visit.
• Participants on ketamine therapy at Screening Visit must agree to discontinue use for at least 14 days prior to the Baseline Observation Period.
• Agree to discontinue any prohibited medications within prior to 14 days of the Baseline Observation Period and for the duration of the study.
• Average daily CRPS pain intensity score in the affected limb of ≥5 and ≤9 on an 11-point (0-10) NRS averaged over 7 days prior to Baseline Visit (Visit 1). This will be based on completion of at least 5 daily pain diary entries during the week prior to Visit 1, with no more than one 24-hour pain intensity score of zero or more than one 24-hour pain intensity score of 10.
• Participants willing and able (e.g., mental and physical condition) to participate in all aspects of the trial, including use of medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing signed written informed consent at Screening Visit.
• For persons of reproductive potential: use of highly effective contraception (females: barrier (condom, diaphragm, sponge, cervical cap) and/or oral, implantable rod, or intrauterine device birth control; males: barrier (condom)) 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.

You may not qualify if:

• Known or suspected cardiovascular disease, arrythmias, and/or respiratory issues.
• Abnormal EKG results, abnormal blood pressure (SBP \<90 or ≥ 140; DBP \<50 or ≥ 90) and/or heart rates (\<50 or \>110).
• Known or suspected psychotic illness or neurologic disease.
• Known or suspected elevated intraocular and/or intracranial pressure.
• Known or suspected renal or urologic conditions or symptoms (i.e., bladder pain syndrome, interstitial cystitis), and/or abnormal baseline urinalysis results.
• Known or suspected hyperthyroidism.
• Allergy, hypersensitivity, or intolerance to ketamine or any of the investigational product excipients.
• Participants receiving opioids ≥30 mg/day morphine milligram equivalents (MME), whether as part of their individual standard treatment regimen for CRPS pain or in context with any other indication, within the last two weeks prior to Visit 1.
• 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.
• Known or suspected acute or chronic alcoholism, delirium tremens, or toxic psychosis.
• Meet DSM-5 criteria for current or past substance use disorder within the last 5 years for any psychoactive substances other than nicotine or caffeine.
• Known hepatic dysfunction or serious liver disease, including presence of aspartate aminotransferase (AST) levels ≥ 2 X upper limit of normal and/or alanine aminotransferase (ALT) levels ≥ 2 X upper limit of normal and/or total bilirubin ≥ 1.5 X upper limit of normal
• Abnormal urinalysis, urine culture or abnormal creatinine
• Evidence of moderate or severe renal impairment (CRCL \<60 ml/min) or participants with renal failure who are on any form of dialysis.
• Current or previous history of seizures.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Pain Center, Keck Medical Center of University of Southern California

Los Angeles, California, 90033, United States

Location

Related Links

• Sammy Al Mukhaizeem, et al. Investigating the effectiveness of oral ketamine on pain, mood and quality of life in treatment resistant chronic pain
• Megan Dutton, et al. Oral ketamine may offer a solution to the ketamine conundrum
• Mark C. Enarson, et al. Clinical Experience with Oral Ketamine
• Glue, et al. Extended-release ketamine tablets for treatment-resistant depression: A randomized placebo-controlled phase 2 trial
• Hasan, M. et al. Chiral Pharmacokinetics and Metabolite Profile of Prolonged-release Ketamine Tablets in Healthy Human Subjects
• Naim Zaki, et al. Long-term safety and maintenance of response with esketamine nasal spray in participants with treatment-resistant depression: interim results of the SUSTAIN-3 study

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Steven Richeimer, MD

  Keck Medical Center of USC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao-Ping Zhang

CONTACT

323-442-6202; yaopingz@usc.edu

Faye Weinstein, PhD

CONTACT

323-442-6202; faye.weinstein@med.usc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Anesthesiology

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 17, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)