Ketamine Tablets for Complex Regional Pain Syndrome

Overseen By Yao-Ping Zhang

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Southern California

Must not be taking: Opioids, Cocaine, Amphetamines, others

Disqualifiers: Cardiovascular disease, Psychotic illness, Renal conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

65 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications. If you are on ketamine therapy, you must stop at least 14 days before the study starts. Additionally, any prohibited medications must be stopped 14 days before the study and throughout its duration.

What data supports the effectiveness of the drug Ketamine HCl Prolonged Release Oral Tablets for treating Complex Regional Pain Syndrome?

Research shows that ketamine, when used in different forms like infusions or topical applications, can help reduce pain in people with Complex Regional Pain Syndrome, although the effects may be temporary. This suggests that ketamine tablets might also offer some pain relief, but more studies are needed to confirm this. ^{1 2 3 4 5}

Is ketamine safe for humans?

Ketamine can cause side effects like feeling detached from reality and increased blood pressure, but these might be less with certain formulations. Some studies show liver issues in chronic users, but these are rare in medical use. Monitoring by doctors is recommended to ensure safety. ^{2 4 6 7 8}

How is the drug Ketamine HCl Prolonged Release Oral Tablets unique for treating complex regional pain syndrome?

Ketamine HCl Prolonged Release Oral Tablets are unique because they offer a prolonged release of ketamine, which is different from other forms like topical or infusion treatments. This oral tablet form may provide a more convenient and sustained delivery of the drug, potentially reducing the frequency of dosing and offering a novel approach compared to the short-term effects seen with other ketamine treatments. ^{1 2 4 9 10}

Research Team

Steven Richeimer, MD

Principal Investigator

Keck Medical Center of USC

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 have had CRPS for at least 6 months.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

1 visit (in-person)

Treatment

Participants receive Ketamine HCl PR tablets, starting with 40mg BID, with potential dose increase at week 4

12 weeks

6 visits (in-person), 4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

Treatment Details

Interventions

• Ketamine HCl Prolonged Release Oral Tablets

Trial Overview 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.

Participant Groups

Group I: 80mg Ketamine HCl PR Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Findings from Research

An extended release oral ketamine tablet was found to be safe and well tolerated in a study of seven patients with treatment-resistant depression/anxiety, with no significant changes in vital signs and only one brief report of dissociation.

All patients experienced over 50% improvements in mood ratings over 96 hours, suggesting that while the onset of mood improvement is slightly delayed compared to injectable forms, this oral formulation could be a promising option for treating resistant depression and anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of extended release ketamine tablets in patients with treatment-resistant depression and anxiety: open label pilot study. Glue, P., Medlicott, NJ., Neehoff, S., et al.[2022]

A review of 41 treatment arms from 21 studies found that ketamine formulations that maximize first pass metabolism and delay the time to peak concentration (Tmax) are associated with better safety and tolerability, particularly in reducing side effects like dissociation and increased blood pressure.

The study revealed strong correlations between the ketamine:norketamine ratio and both dissociation ratings and blood pressure changes, suggesting that careful formulation can help minimize adverse effects while maintaining the antidepressant efficacy of ketamine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of formulation and route of administration on ketamine's safety and tolerability: systematic review. Glue, P., Russell, B., Medlicott, NJ.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Results of the Treatment of Chronic, Refractory CRPS with Ketamine Infusions: a Preliminary Report. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Topical Ketamine in the Treatment of Complex Regional Pain Syndrome. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Intravenous Ketamine Infusion for Complex Regional Pain Syndrome: Survey, Consensus, and a Reference Protocol. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Recurrent Subanesthetic Ketamine Infusions for Complex Regional Pain Syndrome Leading to Biliary Dilation, Jaundice, and Cholangitis: A Case Report. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The use of ketamine in complex regional pain syndrome: possible mechanisms. [2013]

6. Netherlands pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of ketamine for pain relief]. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of extended release ketamine tablets in patients with treatment-resistant depression and anxiety: open label pilot study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Influence of formulation and route of administration on ketamine's safety and tolerability: systematic review. [2021]

9. England pubmed.ncbi.nlm.nih.gov

A possible case of complex regional pain syndrome in the orofacial region. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical application of ketamine ointment in the treatment of sympathetically maintained pain. [2013]