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

NCT02678793 | Completed Phase 2

• 1 other identifier: 4975-MN-203
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 10

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.

Conditions

Morton's Neuroma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

Study Arms (1)

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.

Drug: CNTX-4975

Interventions

CNTX-4975 DRUG

Subjects who have completed Study 4975-MN-202 will be eligible

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• Total abstinence from sexual intercourse since the last menses before IP administration.
• Intrauterine device.
• Double barrier method (condoms, sponge, diaphragm, with spermicidal jellies or cream).
• 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.

You may not qualify if:

• 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.
• Signs of arterial insufficiency in the feet, including clinically meaningful edema.
• Raynaud's disease or phenomenon, previous frostbite, or other cause of vascular instability in the feet resulting from application of cold to the foot.
• Daily use of opioids for any condition.
• Corticosteroid injection in the affected foot within 30 days of Screening.
• 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.
• Clinically significant abnormal laboratory result at the Screening Visit (in the opinion of the investigator).
• Has a positive pregnancy test at the Screening Visit.

Sponsors & Collaborators

• Centrexion Therapeutics: lead

Study Sites (10)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

NEA Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

TriWest Research Associates, LLC

El Cajon, California, 92020, United States

Location

Chesapeake Research Group

Pasadena, Maryland, 21122, United States

Location

Center for Advanced Medicine & Research

City of Saint Peters, Missouri, 63303, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

Allcare Foot and Ankle Centre

Arlington, Texas, 76015, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Morton Neuroma

Interventions

CNTX-4975

Condition Hierarchy (Ancestors)

Metatarsalgia; Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: February 10, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 9, 2018

Record last verified: 2018-05

Locations

US (10)