Halneuron for Neuropathy

Recruiting at 18 trial locations

Overseen By Dogwood Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dogwood Therapeutics Inc.

Disqualifiers: Non-CINP neuropathic pain, Prior HAL

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Halneuron for treating neuropathy?

Research shows that topical doxepin cream, a component of Halneuron, was effective in treating severe peripheral neuropathy in a pediatric patient. Additionally, similar treatments like oxcarbazepine and carbamazepine have been shown to alleviate neuropathic pain, suggesting potential effectiveness for Halneuron. ^{1 2 3 4 5}

What is the purpose of this trial?

A randomized study to determine safety and efficacy of single subcutaneous (SC) administration of HAL treatment in patients with CINP.

Eligibility Criteria

This trial is for adults over 18 who have neuropathic pain due to chemotherapy with taxanes or platinum, and whose cancer isn't currently getting worse. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

I have nerve pain from chemotherapy with platinum or taxane.

I've had chemotherapy with taxanes or platinum and my cancer hasn't gotten worse.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous administration of Halneuron or placebo

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Halneuron

Trial Overview The study tests Halneuron against a placebo in managing chemotherapy-induced neuropathic pain. Participants are randomly assigned to receive either the real drug or a placebo via a single subcutaneous injection.

Participant Groups

Group I: Halneuron Experimental Treatment 1 Intervention

Halneuron

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Dogwood Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

200+

Findings from Research

A 17-year-old girl with acute lymphoblastic leukaemia developed severe peripheral neuropathy as a side effect of her treatment for a mucormycosis infection.

Topical doxepin cream (5%) was found to be a novel and effective treatment for her peripheral neuropathy, showing dramatic and consistent improvement, marking the first reported use of this therapy in a pediatric patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe medication-induced peripheral neuropathy treated with topical doxepin cream in a paediatric patient with leukaemia. Dworsky, ZD., Bennett, R., Kim, JM., et al.[2020]

A predictive model using the XGBoost algorithm was developed to accurately forecast thalidomide-induced peripheral neuropathy (TiPN) in 164 Crohn's disease patients, utilizing 18 clinical features and 150 genetic variables, achieving high accuracy metrics (AUROC > 0.90).

Key risk factors for TiPN included specific genetic markers (like interleukin-12 and brain-derived neurotrophic factor variants) and thalidomide dosage, highlighting the potential for personalized treatment strategies to enhance thalidomide efficacy while minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison and development of machine learning for thalidomide-induced peripheral neuropathy prediction of refractory Crohn's disease in Chinese population. Mao, J., Chao, K., Jiang, FL., et al.[2023]

In a study of 38 patients with painful diabetic neuropathy, long-term treatment with oxcarbazepine significantly reduced pain intensity and improved social functioning over six months, with notable improvements in various pain and activity-related scores.

The treatment was found to be safe, as none of the patients experienced significant side effects that would require discontinuation of the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of oxcarbazepine in symptomatic treatment of painful diabetic neuropathy. Erdemoglu, AK., Varlibas, A.[2018]

In a study of 150 patients with upper extremity idiopathic neuropathy, various patient-reported outcome measures (PROMs) showed moderate to strong correlations, indicating that both specific and general measures can effectively assess symptoms and activity limitations.

Self-reported depression symptoms significantly influenced variations in PROM scores, suggesting that mental health plays a crucial role in the perception of neuropathy symptoms, and highlighting the potential benefit of using a simpler, general PROM for routine assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Nerve-Specific, Condition-Specific, and Upper Extremity-Specific Patient-Reported Outcome Measures in Patients With Carpal and Cubital Tunnel Syndrome. Kortlever, JTP., Somogyi, JR., Ring, D., et al.[2022]

In a one-year study involving 54 patients with diabetic peripheral neuropathy, carbamazepine provided significant symptomatic relief for sensory symptoms, with 49 patients reporting improvement.

Despite the relief from symptoms, nerve conduction velocity (NCV) measurements did not show significant changes, indicating that while carbamazepine is effective for symptom management, it may not address the underlying nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetic peripheral neuropathy: nerve conduction studies before, during and after carbamazepine therapy. Chakrabarti, AK., Samantaray, SK.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Severe medication-induced peripheral neuropathy treated with topical doxepin cream in a paediatric patient with leukaemia. [2020]

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

Comparison and development of machine learning for thalidomide-induced peripheral neuropathy prediction of refractory Crohn's disease in Chinese population. [2023]

3. India pubmed.ncbi.nlm.nih.gov

Effectiveness of oxcarbazepine in symptomatic treatment of painful diabetic neuropathy. [2018]

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

A Comparison of Nerve-Specific, Condition-Specific, and Upper Extremity-Specific Patient-Reported Outcome Measures in Patients With Carpal and Cubital Tunnel Syndrome. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Diabetic peripheral neuropathy: nerve conduction studies before, during and after carbamazepine therapy. [2019]