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

Primary Purpose

Painful Intermetatarsal Neuroma (Morton's Neuroma)

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

About this trial

This is an interventional treatment trial for Painful Intermetatarsal Neuroma (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. Pain associated with intermetatarsal neuroma (Morton's neuroma) for a minimum of 3 months prior to Screening.
  3. Diagnosis of Morton's neuroma, confirmed by evidence of focal tenderness and pain in the distal third intermetatarsal space, AND either

    • Presence of neuroma on ultrasound, or
    • Elicitation of Mulder's sign or a positive Gauthier's test.
  4. A mean neuroma foot pain score of 4 or greater during the 7 days prior to dosing (NPRS, 0-10) as rated daily at bedtime (9:00 PM ± 3 hours) for average pain with walking in the last 24-hours. At least 5 of 7 scores during the week prior to dosing must be recorded.
  5. Tried conservative treatment with analgesics (acetaminophen or nonsteroidal anti-inflammatory drugs) and non-pharmacologic therapy (such as wide shoes, orthotics, and/or arch supports) without complete success.
  6. 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).
  7. Willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, pain scales, and daily IWRS/IVRS entries, and to communicate meaningfully with the study personnel.
  8. Signed an Informed Consent Form approved by the Institutional Review Board.
  9. 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. Clinically significant bursitis in either foot.
  2. The subject has more than one painful intermetatarsal neuroma in the affected foot which, in the opinion of the Investigator, would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma in the affected foot.
  3. Radiography within 6 months of the Treatment Visit (Day 1) to exclude musculoskeletal pathology must be performed, to include any osseous abnormality such as stress fracture, osteophyte, tumor, or cyst in the bones or toes adjacent to the third inter-metatarsal space or any significant evidence of arthritis in the joints of the 3rd and 4th metatarsal-phalangeal joints or inter-phalangeal joints of the 3rd and 4th toes.
  4. Previous neurectomy in the same nerve.
  5. Any painful condition or prior surgery on the affected ankle or foot, which, in the judgment of the investigator, might adversely impact the interpretation of study data.
  6. Other painful foot pathology (e.g., bunion, hammertoe, plantar fasciitis etc.) or evidence of clinically meaningful ischemia which, in the judgment of the investigator and the medical monitor, would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma.
  7. Other chronic pain anywhere in the body that is greater than or equal to the intensity of foot pain from intermetatarsal neuroma.
  8. Signs of arterial insufficiency in the feet, including clinically meaningful edema.
  9. Current use of opioids for any condition.
  10. Corticosteroid injection in the affected foot within 30 days of Screening.
  11. History of clearly documented allergic reaction to local anesthetics or capsaicin.
  12. Prior use of injection with a sclerosing agent, such as alcohol or phenol, in the affected foot for Morton's neuroma.
  13. Presence of any medical condition 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.
  14. Regular use of anticoagulant blood thinners (except low-dose aspirin or Plavix which are allowed).
  15. Active cutaneous disease at the anticipated site of study drug injection that would prevent the safe administration of study drug.
  16. Ulcer or open wound anywhere on the affected foot.
  17. Clinically significant abnormal laboratory result at the Screening Visit (in the opinion of the investigator).
  18. Has diabetic neuropathy or other peripheral neuropathy in the affected foot.
  19. Use of an investigational medication in the 30 days prior to the current study or scheduled to receive such an agent while participating in the current study.
  20. Prior participation in an ALGRX-4975 or CNTX-4975 study.
  21. Has a history of substance use disorder within the previous year as defined by the Diagnostic and Statistical Manual for Mental Health Disorders, fifth edition, has current evidence for a substance use disorder, is receiving medicinal treatment for drug abuse, or tests positive upon urine drug screen for a substance of abuse.
  22. Has a positive pregnancy test at the Screening or Treatment Visit.
  23. Has any condition or is taking any medication that would be contraindicated for study participation.

Sites / Locations

  • Arizona Research Center
  • Premier Research
  • NEA Baptist Clinic
  • Center for Clinical Research, Inc
  • eStudySite, La Mesa
  • TriWest Research Associates
  • Chesapeake Research Group, LLC
  • Center for Advanced Medicine and Research
  • University Orthopedics Center- Altoona
  • University Orthopedics Center
  • Allcare Foot and Ankle Center
  • Premier Research
  • Endeavor Clinical Trials, PA
  • Wasatch Clinical Research, LLC
  • Jean Brown Research
  • The Education and Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

2 mL injection of 200 µg of CNTX-4975

2 mL injection of 600 µg of CNTX-4975

2 mL injection of placebo

2 mL injection of 25 µg of CNTX-4975

Arm Description

Single dose, 2 mL

Single dose, 2 mL

Single dose, 2 mL

Single dose, 2 mL

Outcomes

Primary Outcome Measures

Change from Baseline in average neuroma foot pain (Diary) with walking using the NPRS
Change from Baseline in average neuroma foot pain (Diary) with walking using the NPRS in subjects treated with CNTX-4975 compared with placebo.

Secondary Outcome Measures

Change from Baseline in average neuroma foot pain (Diary) with walking
Change from Baseline during the Follow-up Period in average neuroma foot pain (Diary) with walking using NPRS (mean of daily pain scores for each week).
Change from Baseline during the Follow-up Period in worst neuroma foot pain (Diary)
Change from Baseline during the Follow-up Period in worst neuroma foot pain (Diary) using NPRS (mean of daily pain scores for each week).
Area under the curve (AUC) for average neuroma foot pain (Diary)
Area under the curve (AUC) for average neuroma foot pain (Diary) with walking (NPRS).
Foot Function measured by FFI-R-R
Change from Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12) in foot function as measured by the FFI-R-R.
QOL as measured by the EQ-5D.
Change from Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12) in QOL as measured by the EQ-5D.

Full Information

First Posted
November 3, 2014
Last Updated
December 2, 2016
Sponsor
Centrexion Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02283957
Brief Title
A Study to Evaluate the Efficacy and Safety of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Study 4975-MN-202 is a double-blind, placebo-controlled, parallel group, single-injection study in which subjects will be randomized to receive three doses of CNTX-4975 or placebo injected into the intermetatarsal space around a Morton's neuroma. The injection of study medication will be administered by ultrasound-guided needle placement following ankle block anesthesia. The study staff will telephone subjects at Week 1 postinjection and subjects will return to the clinic postinjection at Weeks 2, 4, 8, and 12 for study assessments.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2 mL injection of 200 µg of CNTX-4975
Arm Type
Experimental
Arm Description
Single dose, 2 mL
Arm Title
2 mL injection of 600 µg of CNTX-4975
Arm Type
Experimental
Arm Description
Single dose, 2 mL
Arm Title
2 mL injection of placebo
Arm Type
Placebo Comparator
Arm Description
Single dose, 2 mL
Arm Title
2 mL injection of 25 µg of CNTX-4975
Arm Type
Experimental
Arm Description
Single dose, 2 mL
Intervention Type
Drug
Intervention Name(s)
CNTX-4975
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from Baseline in average neuroma foot pain (Diary) with walking using the NPRS
Description
Change from Baseline in average neuroma foot pain (Diary) with walking using the NPRS in subjects treated with CNTX-4975 compared with placebo.
Time Frame
Baseline (mean of Day -7 through Day -1), to week 4 (mean of Day 22 through Day 28)
Secondary Outcome Measure Information:
Title
Change from Baseline in average neuroma foot pain (Diary) with walking
Description
Change from Baseline during the Follow-up Period in average neuroma foot pain (Diary) with walking using NPRS (mean of daily pain scores for each week).
Time Frame
Baseline (mean of Day -7 through Day -1), Week 1 through Week 12
Title
Change from Baseline during the Follow-up Period in worst neuroma foot pain (Diary)
Description
Change from Baseline during the Follow-up Period in worst neuroma foot pain (Diary) using NPRS (mean of daily pain scores for each week).
Time Frame
Baseline (mean of Day -7 through Day -1),, Week 1 through Week 12
Title
Area under the curve (AUC) for average neuroma foot pain (Diary)
Description
Area under the curve (AUC) for average neuroma foot pain (Diary) with walking (NPRS).
Time Frame
Baseline (mean of Day -7 through Day -1), to Week 12
Title
Foot Function measured by FFI-R-R
Description
Change from Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12) in foot function as measured by the FFI-R-R.
Time Frame
Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12)
Title
QOL as measured by the EQ-5D.
Description
Change from Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12) in QOL as measured by the EQ-5D.
Time Frame
Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12)

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. Pain associated with intermetatarsal neuroma (Morton's neuroma) for a minimum of 3 months prior to Screening. Diagnosis of Morton's neuroma, confirmed by evidence of focal tenderness and pain in the distal third intermetatarsal space, AND either Presence of neuroma on ultrasound, or Elicitation of Mulder's sign or a positive Gauthier's test. A mean neuroma foot pain score of 4 or greater during the 7 days prior to dosing (NPRS, 0-10) as rated daily at bedtime (9:00 PM ± 3 hours) for average pain with walking in the last 24-hours. At least 5 of 7 scores during the week prior to dosing must be recorded. Tried conservative treatment with analgesics (acetaminophen or nonsteroidal anti-inflammatory drugs) and non-pharmacologic therapy (such as wide shoes, orthotics, and/or arch supports) without complete success. 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 daily 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: Clinically significant bursitis in either foot. The subject has more than one painful intermetatarsal neuroma in the affected foot which, in the opinion of the Investigator, would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma in the affected foot. Radiography within 6 months of the Treatment Visit (Day 1) to exclude musculoskeletal pathology must be performed, to include any osseous abnormality such as stress fracture, osteophyte, tumor, or cyst in the bones or toes adjacent to the third inter-metatarsal space or any significant evidence of arthritis in the joints of the 3rd and 4th metatarsal-phalangeal joints or inter-phalangeal joints of the 3rd and 4th toes. Previous neurectomy in the same nerve. Any painful condition or prior surgery on the affected ankle or foot, which, in the judgment of the investigator, might adversely impact the interpretation of study data. Other painful foot pathology (e.g., bunion, hammertoe, plantar fasciitis etc.) or evidence of clinically meaningful ischemia which, in the judgment of the investigator and the medical monitor, would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma. Other chronic pain anywhere in the body that is greater than or equal to the intensity of foot pain from intermetatarsal neuroma. Signs of arterial insufficiency in the feet, including clinically meaningful edema. Current use of opioids for any condition. Corticosteroid injection in the affected foot within 30 days of Screening. History of clearly documented allergic reaction to local anesthetics or capsaicin. Prior use of injection with a sclerosing agent, such as alcohol or phenol, in the affected foot for Morton's neuroma. Presence of any medical condition 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. Regular use of anticoagulant blood thinners (except low-dose aspirin or Plavix which are allowed). Active cutaneous disease at the anticipated site of study drug injection that would prevent the safe administration of study drug. Ulcer or open wound anywhere on the affected foot. Clinically significant abnormal laboratory result at the Screening Visit (in the opinion of the investigator). Has diabetic neuropathy or other peripheral neuropathy in the affected foot. Use of an investigational medication in the 30 days prior to the current study or scheduled to receive such an agent while participating in the current study. Prior participation in an ALGRX-4975 or CNTX-4975 study. Has a history of substance use disorder within the previous year as defined by the Diagnostic and Statistical Manual for Mental Health Disorders, fifth edition, has current evidence for a substance use disorder, is receiving medicinal treatment for drug abuse, or tests positive upon urine drug screen for a substance of abuse. Has a positive pregnancy test at the Screening or Treatment Visit. Has any condition or is taking any medication that would be contraindicated for study participation.
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Premier Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72410
Country
United States
Facility Name
Center for Clinical Research, Inc
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
eStudySite, La Mesa
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
TriWest Research Associates
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Chesapeake Research Group, LLC
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
Country
United States
Facility Name
Center for Advanced Medicine and Research
City
St. Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
University Orthopedics Center- Altoona
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 Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Premier Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78728
Country
United States
Facility Name
Endeavor Clinical Trials, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Wasatch Clinical Research, LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
The Education and Research Foundation
City
Lynchberg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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