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

Primary Purpose

Morton's Neuroma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CNTX-4975
Sponsored by
Centrexion Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morton's Neuroma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Research Center
  • NEA Baptist Clinic
  • TriWest Research Associates, LLC
  • Chesapeake Research Group
  • Center for Advanced Medicine & Research
  • University Orthopedics Center
  • University Orthopedics Center
  • Allcare Foot and Ankle Centre
  • Wasatch Clinical Research
  • The Education & Research Foundation, Inc.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

Evaluate the safety and tolerability of repeat injections of CNTX-4975 through assessment of incidence, intensity, relationship and seriousness of treatment-emergent adverse events
Evaluate the safety and tolerability of repeat injections of CNTX-4975 through treatment-emergent changes in vital signs and laboratory tests

Secondary Outcome Measures

To evaluate the analgesic efficacy of repeat doses of CNTX-4975 by change in NPRS.
To evaluate the analgesic efficacy of repeat doses of CNTX-4975 by change in Patient Global Impression of Change

Full Information

First Posted
January 18, 2016
Last Updated
May 7, 2018
Sponsor
Centrexion Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02678793
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centrexion Therapeutics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morton's Neuroma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects who have completed Study 4975-MN-202 will be eligible
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
CNTX-4975
Primary Outcome Measure Information:
Title
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.
Title
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.
Secondary Outcome Measure Information:
Title
To evaluate the analgesic efficacy of repeat doses of CNTX-4975 by change in NPRS.
Time Frame
over the course of 1 year.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
TriWest Research Associates, LLC
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Chesapeake Research Group
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
Country
United States
Facility Name
Center for Advanced Medicine & Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
University Orthopedics Center
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
University Orthopedics Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Allcare Foot and Ankle Centre
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
The Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States

12. IPD Sharing Statement

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

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