Clinical trial NCT06848348: Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
Official title: A Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chemotherapy Induced Neuropathic Pain
Keywords: Neuropathic Pain
Chemotherapy
Pain
Neuropathy
Cancer
CIPN
CINP
Lead sponsor: Dogwood Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized study to determine safety and efficacy of single subcutaneous (SC) administration of HAL treatment in patients with CINP.


Eligibility criteria: 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.

Primary outcomes:
measure: To explore the efficacy of Halneuron in the treatment of patients with Chemotherapy-Induced Neuropathic Pain
timeFrame: From enrollment to end of study at 4 weeks
measure: To explore the Safety of Halneuron in the treatment of patients with Chemotherapy-Induced Neuropathic Pain
timeFrame: From enrollment to end of study at 4 weeks
Secondary outcomes:
measure: Responder analyses for patient global impression of change (PGIC)
timeFrame: Enrollment to end of study at week 4
measure: Determine benefits of Halneuron treatment on non-pain outcomes including sleep quality, fatigue and mood
timeFrame: Enrollment to end of study at week 4
measure: Determine benefits of Halneuron treatment on non-pain outcomes including sleep quality, fatigue and mood
timeFrame: Enrollment to end of study at week 4
measure: Determine benefits of Halneuron treatment on non-pain outcomes including sleep quality, fatigue and mood
timeFrame: Enrollment to end of study at week 4
Other outcomes:
Locations:
city: Fair Oaks
country: United States
facility: APEX Research Group, LLC
state: California
city: Fountain Valley
country: United States
facility: Ark Clinical Research
state: California
city: Pasadena
country: United States
facility: Profound Research LLC
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Foundation
state: California
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research
state: Colorado
city: Lakeland
country: United States
facility: TOI Clinical Research
state: Florida
city: Orlando
country: United States
facility: Conquest Research LLC
state: Florida
city: Port Charlotte
country: United States
facility: Medsol Clinical Research Center, Inc
state: Florida
city: Tampa
country: United States
facility: CenExel FCR
state: Florida
city: Atlanta
country: United States
facility: CenExel ACMR
state: Georgia
city: Farmington
country: United States
facility: Profound Research at OMG Division of Clinical Hematology and Medical Oncology
state: Michigan
city: Fenton
country: United States
facility: Circuit Clinical/ SSM St. Clare Cancer Care
state: Missouri
city: Kansas City
country: United States
facility: Saint Lukes Hospital
state: Missouri
city: Las Vegas
country: United States
facility: Exel Clinical Research
state: Nevada
city: Garden City
country: United States
facility: Rubin MD
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates LLC
state: New York
city: Houston
country: United States
facility: Center for Oncology and Blood Disorders
state: Texas
city: Salt Lake City
country: United States
facility: CenExel JBR
state: Utah
city: Madison
country: United States
facility: SSM Health Dean Medical Group
state: Wisconsin
Study officials:
References: