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

Phase 2

Completed

• Conditions: Morton's Neuroma
• Interventions: Drug: CNTX-4975

• Registration Number: NCT02678793
• Lead Sponsor: Centrexion Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-02-09
• Study First Posted: 2016-02-10
• Primary Completion: 2016-12
• Study Completion: 2017-03
• Disposition First Submitted: 2018-04-30
• Disposition First Submitted QC: 2018-04-30
• Status Verified: 2018-05
• Disposition First Posted: 2018-05-02
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects who have completed Study 4975-MN-202 will be eligible	CNTX-4975	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (9)

The Education & Research Foundation, Inc.; 🇺🇸 Lynchburg, Virginia, United States

University Orthopedics Center; 🇺🇸 State College, Pennsylvania, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

NEA Baptist Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Wasatch Clinical Research; 🇺🇸 Salt Lake City, Utah, United States

Center for Advanced Medicine & Research; 🇺🇸 Saint Peters, Missouri, United States

Chesapeake Research Group; 🇺🇸 Pasadena, Maryland, United States

TriWest Research Associates, LLC; 🇺🇸 El Cajon, California, United States

Allcare Foot and Ankle Centre; 🇺🇸 Arlington, Texas, United States