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

Conditions

• Chemotherapy Induced Neuropathic Pain
• Chemotherapy Induced Pain
• Chemotherapy Induced Pain Neuropathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Halneuron — DRUG
  Halneuron for Subcutaneous Injection
• Placebo — DRUG
  Placebo for Subcutaneous Injection
• Halneuron (Open Label Extension) — DRUG
  Halneuron for Subcutaneous Injection

Study Details

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.

Key Dates

Start date

Feb 21, 2025

Status verified

May 2026

Primary completion

Jul 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo
• Experimental: Halneuron
  Halneuron
• Active Comparator: Open Label Extension
  Subjects may choose to continue in an Open Label Extension (OLE) phase if they complete the randomized phase. All subjects regardless of treatment assignment in the randomized phase will receive Halneuron, during the OLE phase of the study, if offered by the clinical site.

Primary Outcome Measure

NRS Pain [ Time Frame: From enrollment to end of study at 4 weeks ]

Central Contacts

• Dogwood Therapeutics
  866-620-9255
  [email protected]

Locations (25)

Find similar trials in Sheffield, AL

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