Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later Jul 2026 → Dec 2026
See other at-risk trials from Dogwood Therapeutics Inc.

Record History

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  1. Enrollment closed, study ongoing
    • Primary and study completion dates pushed to Dec 2026
    • Site details revised at 25 of 25 sites
    • Eligibility criteria expanded, about 5 words
  2. Primary endpoint(s) modifiedv8 Show 5 more changesShow less
    • Enrollment increased: 200 → 240 participants
    • Trial arms changed: 2 → 3
    • Study sites: 24 to 25
    • Interventions: Halneuron (Drug), Placebo (Drug) to Halneuron (Drug), Halneuron (Open Label Extension) (Drug), Placebo (Drug)
    • Secondary endpoints revised (4)
  3. Re-verified, no change to tracked fieldsv7
  4. Study sites: 19 to 24v6
  5. Site details revised at 12 of 19 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Study sites: 2 to 19
    • Start date changed from estimate of Feb 2025 to Feb 21, 2025
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Study title shortened, about 6 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06848348
Lead Sponsor Dogwood Therapeutics Inc.
Conditions
(from sponsor)		 Chemotherapy Induced Neuropathic Pain, Chemotherapy Induced Pain Neuropathy, Chemotherapy Induced Pain
Related terms Breast Neoplasms, Cancer Pain, Colorectal Neoplasms, Neoplasms, Neuralgia, Pain, Peripheral Nervous System Diseases
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov