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

Phase 2Active Not RecruitingNCT06848348

Dogwood Therapeutics Inc.240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

240

Conditions

Chemotherapy Induced Neuropathic Pain Chemotherapy Induced Pain Neuropathy Chemotherapy Induced Pain

Interventions

HalneuronDRUG

Halneuron for Subcutaneous Injection

PlaceboDRUG

Placebo for Subcutaneous Injection

Halneuron (Open Label Extension)DRUG

Halneuron for Subcutaneous Injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (25)

Central Recruiting Site

Sheffield, Alabama, United States

Outcomes

Primary Outcomes

NRS Pain

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

Time frame: From enrollment to end of study at 4 weeks

Safety Assessments

Incidence of serious adverse events (SAEs), adverse events (AEs) and Adverse Events of Special Interests (AESIs)

Time frame: From enrollment to end of study at 4 weeks

Secondary Outcomes

Patient Global Impression of Change (PGIC)

Time frame: Enrollment to end of study at week 4

PROMIS Fatigue

Change from baseline to week 4 on the PROMIS Fatigue instrument

Time frame: Enrollment to end of study at week 4

PROMIS Sleep

Change from baseline to week 4 on PROMIS Sleep instrument

Time frame: Enrollment to end of study at week 4

PROMIS-29 Quality of Life

Change from baseline to week 4 on the domains of the PROMIS-29 instrument

Time frame: Enrollment to end of study at week 4

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.