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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Halneuron | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Halneuron | Drug | Halneuron for Subcutaneous Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | From enrollment to end of study at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGIC) | Patient Global Impression of Change (PGIC) | Enrollment to end of study at week 4 |
| PROMIS Fatigue | Change from baseline to week 4 on the PROMIS Fatigue instrument |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dogwood Therapeutics | Contact | 866-620-9255 | Mehran@dwtx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Recruiting Site | Recruiting | Sheffield | Alabama | 35660 | United States | |
| Central Recruiting Site |
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| Placebo |
| Drug |
Placebo for Subcutaneous Injection |
|
| Halneuron (Open Label Extension) | Drug | Halneuron for Subcutaneous Injection |
|
| Enrollment to end of study at week 4 |
| PROMIS Sleep | Change from baseline to week 4 on PROMIS Sleep instrument | 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 | Enrollment to end of study at week 4 |
| Recruiting |
| Glendale |
| Arizona |
| 85308 |
| United States |
| Central Recruiting Site | Recruiting | Phoenix | Arizona | 85022 | United States |
| Central Recruiting Site | Recruiting | Fair Oaks | California | 95628 | United States |
| Central Recruiting Site | Recruiting | Fountain Valley | California | 92708 | United States |
| Central Recruiting Site | Recruiting | Los Angeles | California | 91307 | United States |
| Central Recruiting Site | Recruiting | Santa Rosa | California | 95403 | United States |
| Central Recruiting Site | Recruiting | Wheat Ridge | Colorado | 80033 | United States |
| Central Recruiting Site | Recruiting | Jacksonville | Florida | 32205 | United States |
| Central Recruiting Site | Recruiting | Jacksonville | Florida | 32256 | United States |
| Central Recruiting Site | Recruiting | Lakeland | Florida | 33812 | United States |
| Central Recruiting Site | Recruiting | Orlando | Florida | 32832 | United States |
| Central Recruiting Site | Recruiting | Port Charlotte | Florida | 33952 | United States |
| Central Recruiting Site | Recruiting | Tampa | Florida | 33613 | United States |
| Central Recruiting Site | Recruiting | Gurnee | Illinois | 60031 | United States |
| Central Recruiting Site | Recruiting | Lake Charles | Louisiana | 70605 | United States |
| Central Recruiting Site | Recruiting | Fenton | Missouri | 63026 | United States |
| Central Recruiting Site | Recruiting | Las Vegas | Nevada | 89109 | United States |
| Central Recruiting Site | Recruiting | Garden City | New York | 11530 | United States |
| Central Recruiting Site | Recruiting | Williamsville | New York | 14221 | United States |
| Central Recruiting Site | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
| Central Recruiting Site | Recruiting | Houston | Texas | 77346 | United States |
| Central Recruiting Site | Recruiting | McAllen | Texas | 78504 | United States |
| Central Recruiting Site | Recruiting | Salt Lake City | Utah | 84107 | United States |
| Central Recruiting Site | Recruiting | Madison | Wisconsin | 53715 | United States |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009369 | Neoplasms |
| D009437 | Neuralgia |
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D000072716 | Cancer Pain |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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