NCT06848348

A Randomized, Double-Blind, Placebo Controlled, Multicenter Study With Optional Open-Label Extension to Evaluate the Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain

Recruiting now Phase 2 Last updated 27 May 2026

What this trial tests

Phase 2 trial testing Halneuron in Chemotherapy Induced Neuropathic Pain in 240 participants. Currently enrolling.

Timeline

21 February 2025

Primary endpoint
1 July 2026

1 August 2026

Quick facts

Lead sponsor	Dogwood Therapeutics Inc.
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	240
Start date	21 February 2025
Primary completion	1 July 2026
Estimated completion	1 August 2026
Sites	25 locations across United States

Drugs / interventions tested

• Halneuron — full drug profile →
• Placebo
• Halneuron (Open Label Extension)

Conditions studied

• Chemotherapy Induced Neuropathic Pain — all drugs for Chemotherapy Induced Neuropathic Pain →
• Chemotherapy Induced Pain Neuropathy — all drugs for Chemotherapy Induced Pain Neuropathy →
• Chemotherapy Induced Pain — all drugs for Chemotherapy Induced Pain →

Sponsor

Dogwood Therapeutics Inc. — full company profile →

Who can join

18 and older, any sex, with Chemotherapy Induced Neuropathic Pain or Chemotherapy Induced Pain Neuropathy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• NRS Pain
  Time frame: From enrollment to end of study at 4 weeks
  Change from Baseline in the weekly average of daily 24-hour pain intensity scores analyzed by percentage of responders among patients treated with Halneuron compared to Placebo
• Safety Assessments
  Time frame: From enrollment to end of study at 4 weeks
  Incidence of serious adverse events (SAEs), adverse events (AEs) and Adverse Events of Special Interests (AESIs)

Sponsor's own description

A randomized study to determine safety and efficacy of a series of subcutaneous (SC) injections of HAL in patients with CINP, compared to matching placebo injections. After that, subjects may have the option to enter an Open Label extension phase, where available, in which all subjects will receive Halneuron.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent advances in the pharmacology of voltage-gated ion channels.
   Lopez-Mateos D, Harris BJ, Hernández-González A, Yarov-Yarovoy V, et al · · 2025 · cited 4× · PMID 41092810 · DOI 10.1016/j.pharmr.2025.100090
2. Transforming Pain Management: Suzetrigine, a Novel Non-Opioid Analgesic.
   AlDoughaim M, AlSuhebany N, AlZahrani M, AlDairem A, et al · · 2025 · cited 1× · PMID 41027858 · DOI 10.4062/biomolther.2025.046