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

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

Tracking Information

• First Submitted Date: January 18, 2016
• First Posted Date: February 10, 2016
• Last Update Posted Date: May 9, 2018
• Study Start Date: December 2015
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 9, 2016)

• 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. ]
• 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. ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 9, 2016)

• To evaluate the analgesic efficacy of repeat doses of CNTX-4975 by change in NPRS. [ Time Frame: 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 [ Time Frame: over the course of 1 year. ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)
• 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)
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Morton's Neuroma
• Intervention: Drug: CNTX-4975

Study Arms

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.

Intervention: Drug: CNTX-4975

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2018): 67
• Original Estimated Enrollment (submitted: February 9, 2016): 85
• Actual Study Completion Date: March 2017
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02678793
• Other Study ID Numbers: 4975-MN-203
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Centrexion Therapeutics
• Study Sponsor: Centrexion Therapeutics
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Centrexion Therapeutics
• Verification Date: May 2018