200 Participants Needed

Halneuron for Neuropathy

Recruiting at 18 trial locations
DT
Overseen ByDogwood Therapeutics
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Dogwood Therapeutics Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HalneuronExperimental Treatment1 Intervention
Halneuron
Group II: PlaceboPlacebo Group1 Intervention
Placebo

Find a Clinic Near You

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

References

Severe medication-induced peripheral neuropathy treated with topical doxepin cream in a paediatric patient with leukaemia. [2020]
Comparison and development of machine learning for thalidomide-induced peripheral neuropathy prediction of refractory Crohn's disease in Chinese population. [2023]
Effectiveness of oxcarbazepine in symptomatic treatment of painful diabetic neuropathy. [2018]
A Comparison of Nerve-Specific, Condition-Specific, and Upper Extremity-Specific Patient-Reported Outcome Measures in Patients With Carpal and Cubital Tunnel Syndrome. [2022]
Diabetic peripheral neuropathy: nerve conduction studies before, during and after carbamazepine therapy. [2019]
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