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)
Sponsor study identifier
interventional
67
1 country
10
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Actual (reported)Study Completion
March 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
January 18, 2016
Actual (reported)February 10, 2016
Actual (reported)December 2016
Actual (reported)March 2017
Actual (reported)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.
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.
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.
Arizona Research Center
Phoenix, Arizona, 85023, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
TriWest Research Associates, LLC
El Cajon, California, 92020, United States
Chesapeake Research Group
Pasadena, Maryland, 21122, United States
Center for Advanced Medicine & Research
City of Saint Peters, Missouri, 63303, United States
University Orthopedics Center
Altoona, Pennsylvania, 16602, United States
University Orthopedics Center
State College, Pennsylvania, 16801, United States
67 participants (actual enrollment reported by the registry).
First Submitted
January 18, 2016
First Posted
February 10, 2016
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Allcare Foot and Ankle Centre
Arlington, Texas, 76015, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501, United States
Primary Completion
December 2016
Actual (reported)Study Completion
March 2017
Actual (reported)Last Updated
May 9, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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