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A Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)

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ClinicalTrials.gov Identifier: NCT02678793
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Morton's Neuroma Drug: CNTX-4975 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multiple-Dose Extension Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)
Study Start Date : December 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017
Arms and Interventions
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Arm Intervention/treatment
Subjects who have completed Study 4975-MN-202 will be eligible
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.
 Drug: CNTX-4975


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the safety and tolerability of repeat injections of CNTX-4975 through assessment of incidence, intensity, relationship and seriousness of treatment-emergent adverse events [ Time Frame: over the course of 1 year. ]
  2. Evaluate the safety and tolerability of repeat injections of CNTX-4975 through treatment-emergent changes in vital signs and laboratory tests [ Time Frame: over the course of 1 year. ]

Secondary Outcome Measures :
  1. To evaluate the analgesic efficacy of repeat doses of CNTX-4975 by change in NPRS. [ Time Frame: over the course of 1 year. ]
  2. To evaluate the analgesic efficacy of repeat doses of CNTX-4975 by change in Patient Global Impression of Change [ Time Frame: over the course of 1 year. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female aged >18 years at the time of the Screening Visit.
  2. Completion of study 4975-MN-202.

  3. 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:

    1. Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before investigational product (IP) administration.
    2. Total abstinence from sexual intercourse since the last menses before IP administration.
    3. Intrauterine device.
    4. Double barrier method (condoms, sponge, diaphragm, with spermicidal jellies or cream).
  4. 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.
  5. Signed an Informed Consent Form approved by the Institutional Review Board.
  6. 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:

  1. Other chronic pain anywhere in the body that is severe in intensity or would interfere with the subject's ability to evaluate foot pain from intermetatarsal neuroma.
  2. Signs of arterial insufficiency in the feet, including clinically meaningful edema.
  3. Raynaud's disease or phenomenon, previous frostbite, or other cause of vascular instability in the feet resulting from application of cold to the foot.
  4. Daily use of opioids for any condition.
  5. Corticosteroid injection in the affected foot within 30 days of Screening.
  6. Presence of any medical condition (or taking any medication) or unstable health status that, in the judgment of the investigator, might adversely impact the conduct of the study or resulting data, including chronic conditions that are likely to alter the rate of healing or are likely to result in safety complications unrelated to the study medication, such as uncontrolled diabetes mellitus or vascular disease.
  7. Clinically significant abnormal laboratory result at the Screening Visit (in the opinion of the investigator).
  8. Has a positive pregnancy test at the Screening Visit.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678793


Locations
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United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, Arkansas
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
United States, California
TriWest Research Associates, LLC
El Cajon, California, United States, 92020
United States, Maryland
Chesapeake Research Group
Pasadena, Maryland, United States, 21122
United States, Missouri
Center for Advanced Medicine & Research
Saint Peters, Missouri, United States, 63303
United States, Pennsylvania
University Orthopedics Center
Altoona, Pennsylvania, United States, 16602
University Orthopedics Center
State College, Pennsylvania, United States, 16801
United States, Texas
Allcare Foot and Ankle Centre
Arlington, Texas, United States, 76015
United States, Utah
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
United States, Virginia
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Centrexion Therapeutics
More Information
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Responsible Party: Centrexion Therapeutics
ClinicalTrials.gov Identifier: NCT02678793    
Other Study ID Numbers: 4975-MN-203
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Neuroma
Morton Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Metatarsalgia
Foot Diseases
 Musculoskeletal Diseases
Joint Diseases
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations