Kindolor for Chronic Pain

Overseen By Administrative Assistant

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Lohocla Research Corporation

Must not be taking: Cannabis, MAOIs, CYP3A4 inhibitors

Disqualifiers: Drug sensitivity, Alcohol use, Hepatitis, others

Compensation: Varies

Number of Visits: 2

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safest dose and understand how the body processes a new medication called Kindolor, which may help manage chronic pain. Healthy volunteers will receive either Kindolor or a placebo to compare results. Ideal candidates are healthy individuals who do not take medications regularly and meet specific health criteria, such as maintaining a steady weight.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any over-the-counter or prescription medications, vitamins, and herbal supplements at least 2 weeks before the study starts.

Is there any evidence suggesting that Kindolor is likely to be safe for humans?

Research has shown that Kindolor has promising safety results. Earlier trials found no safety issues, despite ending early for other reasons. Kindolor is designed to control pain without the addiction risk associated with opiates. Preclinical tests in the lab and on animals demonstrated its effectiveness and safety. It also appears to be processed smoothly by the body. While more research is needed, initial findings suggest that Kindolor is well-tolerated in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for chronic pain, which often include opioids, NSAIDs, or anticonvulsants, Kindolor is a novel approach that uses Kindolor Tosylate as its active ingredient. This treatment is unique because it potentially offers effective pain relief without the common side effects associated with opioids, such as addiction or tolerance. Researchers are particularly excited about Kindolor because its mechanism targets pain pathways differently, offering hope for patients who have not responded well to existing therapies. Additionally, the various dosing regimens being tested could provide flexibility in pain management tailored to individual patient needs.

What evidence suggests that Kindolor might be an effective treatment for chronic pain?

Research has shown that Kindolor has potential in reducing or eliminating chronic pain based on early animal studies. Conducted with five different types of animals, these studies suggest that Kindolor might help manage chronic pain. Although limited information exists from human studies, Kindolor has shown important signs of being effective and safe. This trial will test different dosages of Kindolor in separate cohorts to determine if these early results will be similar in humans. Overall, the initial findings offer hope that Kindolor could become a new option for people with chronic pain. ^{1 2 3 6 7}

Who Is on the Research Team?

Mark Wallace, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study to determine the safe dosage of Kindolor, a drug intended for chronic pain management. Participants will be closely monitored through medical tests before and after receiving the medication.

Inclusion Criteria

I am a healthy adult between 18 and 55 years old.

My lab tests were normal at my last check-up.

Expected to complete the study protocol

Exclusion Criteria

My drug test was positive for certain substances.

History of significant sensitivity to any drug

My kidney function test shows abnormal results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive Kindolor or placebo and remain in the clinic for safety assessments and blood collections

2 days

In-patient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Kindolor

Trial Overview The study is testing different doses of Kindolor Tosylate compared to a placebo. The focus is on finding out what dose is safe and how the body processes it. Volunteers are randomly assigned to receive either Kindolor or an inactive substance.

How Is the Trial Designed?

Group I: Kindolor Cohort 4 Experimental Treatment 1 Intervention

Kindolor Tosylate 6 tablets dose 300mg NPO for 8hrs x1 AM PO ex aq

Group II: Kindolor Cohort 3 Experimental Treatment 1 Intervention

Kindolor Tosylate 3 tablets dose 300mg NPO for 8hrs x1 AM PO ex aq

Group III: Kindolor Cohort 2 Experimental Treatment 1 Intervention

Kindolor Tosylate tablet 1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq

Group IV: Kindolor Cohort 1 Experimental Treatment 1 Intervention

Kindolor Tosylate 1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq

Group V: Placebo Comparator Placebo Group 1 Intervention

Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq

Who Is Running the Clinical Trial?

Lohocla Research Corporation

Lead Sponsor

Trials

2

Recruited

60+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Only 49% of randomized clinical trials (RCTs) for chronic pain in children identified a primary outcome measure, highlighting a significant gap in standardized reporting practices.

Less than 50% of the studies adhered to recommended guidelines for reporting adverse events, and discussions on recruitment and retention challenges were often inadequate, indicating a need for improved trial design and reporting in pediatric pain research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Reporting Characteristics of Clinical Trials of Select Chronic and Recurrent Pediatric Pain Conditions: An Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks Systematic Review. Connolly, MR., Chaudari, JY., Yang, X., et al.[2022]

A meta-analysis of 12 studies involving 88 patients indicates that Ketamine significantly reduces neuropathic pain compared to placebo, although the effects are typically short-lived after administration.

Ketamine has shown promise as an alternative to opioids for chronic pain management, with some studies reporting positive long-term outcomes, but further research with larger sample sizes is needed to confirm its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ketamine for treatment of chronic pain: meta-analysis]. Wiedemann, B.[2019]

Opioids can be effective and relatively safe options for managing pain, but they are often avoided due to concerns about potential side effects and adverse events.

The side effects of opioids can affect multiple body systems, but with proper management and quick intervention, these effects can be addressed, allowing opioids to be used safely and effectively for pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and treating opioid-associated adverse effects. Herndon, CM., Kalauokalani, DA., Cunningham, AJ., et al.[2019]

Ketamine shows moderate to weak evidence for efficacy in managing chronic pain, with level II evidence supporting its use for conditions like fibromyalgia and ischemic pain, while also being considered a 'third line' option when standard treatments fail.

For specific pain conditions such as phantom limb pain and postherpetic neuralgia, ketamine has demonstrated substantial pain relief, indicating its potential as an effective treatment in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine in chronic pain management: an evidence-based review. Hocking, G., Cousins, MJ.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7591148/

Controlling the “Opioid Epidemic”: A Novel Chemical Entity ... In our initial preclinical studies, we demonstrated the efficacy of Kindolor to reduce or eliminate chronic pain in five animal models.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06243835

A Study to Test the Effects of Kindolor at Different Doses ... The goal of this study is to test Kindolor in healthy adults. The main questions it aims to answer are: What is the safe dose of Kindolor in healthy ...

3. reporter.nih.gov reporter.nih.gov/project-details/10449288

Kindolor In our pre-clinical studies we have demonstrated the efficacy of Kindolor to reduce or eliminate chronic pain generated in five animal models at doses ...

4. lohocla.org lohocla.org/media/pdf/LohoclaResearch_Kindolor_Phase1-trials_PRESS_RELEASE.pdf

Lohocla Research Embarks Upon Phase 1 Human Trials ... Kindolor has exhibited all necessary characteristics indicating its effectiveness and safety in treating chronic pain. In pre-clinical studies, ...

5. researchgate.net researchgate.net/publication/346554783_Controlling_the_Opioid_Epidemic_A_Novel_Chemical_Entity_NCE_to_Reduce_or_Supplant_Opiate_Use_for_Chronic_Pain

(PDF) Controlling the "Opioid Epidemic": A Novel Chemical ... In our initial preclinical studies, we demonstrated the efficacy of Kindolor to reduce or eliminate chronic pain in five animal models.

6. lohocla.org lohocla.org/media/pdf/LohoclaResearch_Kindolor_IND_approval_PRESS_RELEASE.pdf

CORPORATION Kindolor has exhibited all necessary characteristics indicating its effectiveness and safety in treating chronic pain. In pre-clinical studies, ...

7. lohocla.com lohocla.com/research/pipeline/kindolor.php

Kindolor® Initial evidence demonstrates the safety (high TI) of Kindolor as well as its uneventful metabolism. Additional attractive features of Kindolor are that it can ...