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

Dogwood Therapeutics Inc.

Status and phase: Enrolling; Phase 2

Conditions: Chemotherapy Induced Neuropathic Pain

Treatments: 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 single subcutaneous (SC) administration of HAL treatment in patients with CINP.

Enrollment: 200 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: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Halneuron

Experimental group

Description:

Halneuron

Treatment:

Drug: Halneuron