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

Dogwood Therapeutics Inc.

Status and phase: Active, not recruiting; Phase 2

Conditions: Chemotherapy Induced Pain; Chemotherapy Induced Pain Neuropathy; Chemotherapy Induced Neuropathic Pain

Treatments: Drug: Halneuron (Open Label Extension); Drug: Halneuron; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06848348

HAL-CINP-203

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients aged ≥18 years.
• Neuropathic pain has been present and is attributed to platinum and/or taxane chemotherapy.
• Patient has received a cancer chemotherapy regimen that included taxanes and/or platinum and has no active or discernible disease progression.

Exclusion criteria

• Current neuropathic pain with symptoms similar to CINP but attributed to causes other than platinum or taxane chemotherapy.
• Patients who have received HAL at any time prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Halneuron

Experimental group

Description:

Halneuron

Treatment:

Drug: Halneuron

Open Label Extension

Active Comparator group

Description:

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.

Treatment:

Drug: Halneuron

Drug: Halneuron (Open Label Extension)