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Subjects who have completed study 4975-MN-202 will be eligible to receive open-label treatment with CNTX-4975 200 µg in study 4975-MN-203 if they meet the inclusion/exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects who have completed Study 4975-MN-202 will be eligible | Other | Subjects who have completed Study 4975-MN-202 will be eligible to receive open-label treatment with CNTX-4975 200 μg in Study 4975-MN-203 if they meet the inclusion/exclusion criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTX-4975 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of repeat injections of CNTX-4975 through assessment of incidence, intensity, relationship and seriousness of treatment-emergent adverse events | over the course of 1 year. | |
| Evaluate the safety and tolerability of repeat injections of CNTX-4975 through treatment-emergent changes in vital signs and laboratory tests | over the course of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the analgesic efficacy of repeat doses of CNTX-4975 by change in NPRS. | over the course of 1 year. | |
| To evaluate the analgesic efficacy of repeat doses of CNTX-4975 by change in Patient Global Impression of Change | over the course of 1 year. |
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Inclusion Criteria:
Male or female aged >18 years at the time of the Screening Visit.
Completion of study 4975-MN-202.
Female not of childbearing potential, defined as post-menopausal for at least 1 year, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing one of the following medically acceptable methods of birth control throughout the study period:
Willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, pain scales, and weekly IWRS/IVRS entries, and to communicate meaningfully with the study personnel.
Signed an Informed Consent Form approved by the Institutional Review Board.
Subject agrees to take only the rescue medications for neuroma foot pain from the time of screening through study completion, and agrees to discontinue all topical medications for neuroma pain after Screening.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85023 | United States | ||
| NEA Baptist Clinic |
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| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| TriWest Research Associates, LLC | El Cajon | California | 92020 | United States |
| Chesapeake Research Group | Pasadena | Maryland | 21122 | United States |
| Center for Advanced Medicine & Research | City of Saint Peters | Missouri | 63303 | United States |
| University Orthopedics Center | Altoona | Pennsylvania | 16602 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16801 | United States |
| Allcare Foot and Ankle Centre | Arlington | Texas | 76015 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| The Education & Research Foundation, Inc. | Lynchburg | Virginia | 24501 | United States |
| ID | Term |
|---|---|
| D000070607 | Morton Neuroma |
| ID | Term |
|---|---|
| D037061 | Metatarsalgia |
| D005534 | Foot Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000656706 | CNTX-4975 |
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