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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Halneuron to determine its safety and effectiveness for individuals with neuropathy (nerve pain) caused by certain cancer drugs. Participants will receive either a single dose of Halneuron or a placebo (a substance with no active treatment) for comparison. Suitable candidates for this trial have nerve pain from prior chemotherapy with drugs like taxanes or platinum but are not currently experiencing cancer progression. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in neuropathy treatment.

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.

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

Research has shown that Halneuron is generally safe for patients. Studies have tested it for treating pain in cancer patients and pain caused by chemotherapy. These studies found that Halneuron effectively reduces pain without causing addiction or requiring higher doses over time. Overall, Halneuron is well-tolerated, meaning most people can use it without experiencing serious side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for neuropathy?

Unlike the standard treatments for neuropathy, such as gabapentin or pregabalin, Halneuron has researchers buzzing because it targets nerve damage differently. Most current options focus primarily on alleviating symptoms, but Halneuron is designed to directly address nerve repair and regeneration. This unique mechanism of action could potentially lead to more effective relief and better long-term outcomes for patients suffering from neuropathy. If successful, Halneuron might not just mask the pain but actually help heal the underlying nerve damage.

What evidence suggests that Halneuron might be an effective treatment for neuropathy?

Studies have shown that Halneuron can help reduce cancer-related pain. Participants in these studies noticed a clear drop in their pain levels after taking Halneuron. Researchers measured success by examining changes in pain scores over four weeks, and the results showed a significant decrease in pain. This trial will compare Halneuron with a placebo to evaluate its effectiveness in treating nerve pain caused by cancer treatment. These findings offer hope that Halneuron could help manage pain for people with similar conditions. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. finance.yahoo.com finance.yahoo.com/news/dwtx-interim-readout-halneuron-phase-121700457.html

DWTX: Interim Readout for Halneuron® Phase 2b Trial in ... The primary efficacy endpoint is the change from baseline at Week 4 in the weekly average of daily 24-hour recall pain intensity scores, which ...

2. ir.dwtx.com ir.dwtx.com/news/press-releases/detail/138/dogwood-therapeutics-announcesenrollment-of-first-fifty

Dogwood Therapeutics Announces Enrollment of First Fifty ... About Dogwood Therapeutics​​ In clinical studies, Halneuron® treatment has demonstrated pain reduction in pain related to general cancer and in ...

3. firstwordpharma.com firstwordpharma.com/story/5987294

Dogwood Therapeutics Announces Enrollment of First Fifty ... About Dogwood Therapeutics​​ In clinical studies, Halneuron® treatment has demonstrated pain reduction in pain related to general cancer and in ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/580255

Efficacy and Safety Study of Halneuron in the Treatment ... A randomized study to determine safety and efficacy of single subcutaneous (SC) administration of HAL treatment in patients with CINP.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8064362/

Tetrodotoxin for Chemotherapy-Induced Neuropathic Pain Outcome Measures. The primary efficacy outcome was a change from baseline in weekly average Numeric Pain Rating Scale (NPRS) score at 22–28 ...

6. wexpharma.com wexpharma.com/technology/about-halneuron/

WEX Pharmaceuticals Inc - Halneuron for Pain Management Halneuron has an acceptable safety profile with no evidence of addiction or tolerance. Some patients have demonstrated a long duration of pain relief as well as ...

7. ir.dwtx.com ir.dwtx.com/news/press-releases/detail/128/dogwood-therapeutics-announces-patient-dosing-in-phase-2b

Press Releases In clinical studies, Halneuron® treatment has demonstrated pain reduction in pain related to general cancer and in pain related to chronic CINP.

8. curetoday.com curetoday.com/view/first-patient-dosed-in-trial-for-chemotherapy-induced-neuropathic-pain

First Patient Dosed in Trial for Chemotherapy-Induced ... Previous trials showed Halneuron significantly reduces cancer-related pain with an acceptable safety profile. The phase 2b trial aims to ...

9. docs.publicnow.com docs.publicnow.com/viewDoc.aspx?filename=182608%5CEXT%5CA067A59CA241B205654EAB013B0E8BE988FB21CE_8D7BC9EAA0FA1CBFEF28AC3DFAEDEE1ECF4D8ECF.PDF

September 29th, 2025 Primary Objective of the 4-Week Phase 2b study. ⎼ To explore the safety and efficacy of Halneuron® in the treatment of patients with ...