Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
A Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
1 other identifier
interventional
200
1 country
24
Brief Summary
A randomized study to determine safety and efficacy of single subcutaneous (SC) administration of HAL treatment in patients with CINP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2025
Shorter than P25 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2025
CompletedStudy Start
First participant enrolled
February 21, 2025
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
January 12, 2026
January 1, 2026
1.4 years
February 3, 2025
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To explore the efficacy of Halneuron in the treatment of patients with Chemotherapy-Induced Neuropathic 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
From enrollment to end of study at 4 weeks
To explore the Safety of Halneuron in the treatment of patients with Chemotherapy-Induced Neuropathic Pain
Incidence of serious adverse events (SAEs), adverse events (AEs) and Adverse Events of Special Interests (AESIs)
From enrollment to end of study at 4 weeks
Secondary Outcomes (4)
Responder analyses for patient global impression of change (PGIC)
Enrollment to end of study at week 4
Determine benefits of Halneuron treatment on non-pain outcomes including sleep quality, fatigue and mood
Enrollment to end of study at week 4
Determine benefits of Halneuron treatment on non-pain outcomes including sleep quality, fatigue and mood
Enrollment to end of study at week 4
Determine benefits of Halneuron treatment on non-pain outcomes including sleep quality, fatigue and mood
Enrollment to end of study at week 4
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo
Halneuron
EXPERIMENTALHalneuron
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Central Recruiting Site
Sheffield, Alabama, 35660, United States
Central Recruiting Site
Glendale, Arizona, 85308, United States
Central Recruiting Site
Fair Oaks, California, 95628, United States
Central Recruiting Site
Fountain Valley, California, 92708, United States
Central Recruiting Site
Los Angeles, California, 91307, United States
Central Recruiting Site
Santa Rosa, California, 95403, United States
Central Recruiting Site
Wheat Ridge, Colorado, 80033, United States
Central Recruiting Site
Jacksonville, Florida, 32205, United States
Central Recruiting Site
Jacksonville, Florida, 32256, United States
Central Recruiting Site
Lakeland, Florida, 33812, United States
Central Recruiting Site
Orlando, Florida, 32832, United States
Central Recruiting Site
Port Charlotte, Florida, 33952, United States
Central Recruiting Site
Tampa, Florida, 33613, United States
Central Recruiting Site
Atlanta, Georgia, 30331, United States
Central Recruiting Site
Gurnee, Illinois, 60031, United States
Central Recruiting Site
Farmington, Michigan, 48334, United States
Central Recruiting Site
Fenton, Missouri, 63026, United States
Central Recruiting Site
Kansas City, Missouri, 64111, United States
Central Recruiting Site
Las Vegas, Nevada, 89109, United States
Central Recruiting Site
Garden City, New York, 11530, United States
Central Recruiting Site
Williamsville, New York, 14221, United States
Central Recruiting Site
Winston-Salem, North Carolina, 27103, United States
Central Recruiting Site
Salt Lake City, Utah, 84107, United States
Central Recruiting Site
Madison, Wisconsin, 53715, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2025
First Posted
February 27, 2025
Study Start
February 21, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR