Chemotherapy Induced Neuropathic PainPhase 2NCT06848348
Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
A Phase 2 study testing Halneuron and Halneuron (Open Label Extension) in people with Chemotherapy Induced Neuropathic Pain and Chemotherapy Induced Pain Neuropathy, run by Dogwood Therapeutics Inc. at 25 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Induced Neuropathic Pain, Chemotherapy Induced Pain Neuropathy, Chemotherapy Induced Pain
- What is being tested?
- Halneuron and Halneuron (Open Label Extension)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 25 sitesUnited States
- Study dates
- 21 Feb 2025to Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Central Recruiting Site
Fair Oaks, California, 95628
Central Recruiting Site
Fenton, Missouri, 63026
Central Recruiting Site
Fountain Valley, California, 92708
Central Recruiting Site
Garden City, New York, 11530
Central Recruiting Site
Glendale, Arizona, 85308
Central Recruiting Site
Gurnee, Illinois, 60031
Central Recruiting Site
Houston, Texas, 77346
Central Recruiting Site
Jacksonville, Florida, 32205
Central Recruiting Site
Jacksonville, Florida, 32256
Central Recruiting Site
Lake Charles, Louisiana, 70605
Central Recruiting Site
Lakeland, Florida, 33812
Central Recruiting Site
Las Vegas, Nevada, 89109
Central Recruiting Site
Los Angeles, California, 91307
Central Recruiting Site
Madison, Wisconsin, 53715
Central Recruiting Site
McAllen, Texas, 78504
Central Recruiting Site
Orlando, Florida, 32832
Central Recruiting Site
Phoenix, Arizona, 85022
Central Recruiting Site
Port Charlotte, Florida, 33952
Central Recruiting Site
Salt Lake City, Utah, 84107
Central Recruiting Site
Santa Rosa, California, 95403
Central Recruiting Site
Sheffield, Alabama, 35660
Central Recruiting Site
Tampa, Florida, 33613
Central Recruiting Site
Wheat Ridge, Colorado, 80033
Central Recruiting Site
Williamsville, New York, 14221
Central Recruiting Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Multicenter Study With Optional Open-Label Extension to Evaluate the Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
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.
- Conditions
- Chemotherapy Induced Neuropathic Pain, Chemotherapy Induced Pain Neuropathy, Chemotherapy Induced Pain
- Being tested
- Halneuron, Placebo, Halneuron (Open Label Extension)
- Keywords
- Chemotherapy, Pain, Neuropathy, Cancer, CIPN, CINP, Chemotherapy Induced, Neuropathic Pain, Breast Cancer, Colorectal Cancer, Cancer Pain, Peripheral Neuropathy
- Medical subject headings
- Pain, Neoplasms, Neuralgia, Breast Neoplasms, Colorectal Neoplasms, Cancer Pain, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HalneuronDrug
Halneuron for Subcutaneous Injection
PlaceboDrug
Placebo for Subcutaneous Injection
Halneuron (Open Label Extension)Drug
Halneuron for Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Halneuron | Experimental | Halneuron Receives: Drug: Halneuron |
| Open Label Extension | Active comparator | 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. Receives: Drug: Halneuron; Drug: Halneuron (Open Label Extension) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: From enrollment to end of study at 4 weeks
Secondary outcomes (4)
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC)
Measured: Enrollment to end of study at week 4
PROMIS Fatigue
Change from baseline to week 4 on the PROMIS Fatigue instrument
Measured: Enrollment to end of study at week 4
PROMIS Sleep
Change from baseline to week 4 on PROMIS Sleep instrument
Measured: 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
Measured: Enrollment to end of study at week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start21 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dogwood Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848348
- Sponsor's protocol ID
- HAL-CINP-203
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes