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

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)

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.

Study Overview

• Status: Completed
• Conditions: Morton's Neuroma
• Intervention / Treatment: Drug: CNTX-4975

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
  • California
    • El Cajon, California, United States, 92020
      • TriWest Research Associates, LLC
  • Maryland
    • Pasadena, Maryland, United States, 21122
      • Chesapeake Research Group
  • Missouri
    • Saint Peters, Missouri, United States, 63303
      • Center for Advanced Medicine & Research
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • University Orthopedics Center
    • State College, Pennsylvania, United States, 16801
      • University Orthopedics Center
  • Texas
    • Arlington, Texas, United States, 76015
      • Allcare Foot and Ankle Centre
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education & Research Foundation, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Centrexion Therapeutics

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: February 9, 2016
• First Posted (Estimate): February 10, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Pain; Neurologic Manifestations; Foot Diseases; Joint Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Neoplasms, Nerve Tissue; Peripheral Nervous System Diseases; Neuralgia; Nerve Sheath Neoplasms; Metatarsalgia; Neuroma; Morton Neuroma
• Other Study ID Numbers: 4975-MN-203