Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02283957
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics

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.

Condition or disease Intervention/treatment Phase
Painful Intermetatarsal Neuroma (Morton's Neuroma) Drug: CNTX-4975 Other: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: 2 mL injection of 200 µg of CNTX-4975
Single dose, 2 mL
Drug: CNTX-4975
Experimental: 2 mL injection of 600 µg of CNTX-4975
Single dose, 2 mL
Drug: CNTX-4975
Placebo Comparator: 2 mL injection of placebo
Single dose, 2 mL
Other: Placebo
Experimental: 2 mL injection of 25 µg of CNTX-4975
Single dose, 2 mL
Drug: CNTX-4975



Primary Outcome Measures :
  1. Change from Baseline in average neuroma foot pain (Diary) with walking using the NPRS [ Time Frame: Baseline (mean of Day -7 through Day -1), to week 4 (mean of Day 22 through Day 28) ]
    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 :
  1. Change from Baseline in average neuroma foot pain (Diary) with walking [ Time Frame: Baseline (mean of Day -7 through Day -1), Week 1 through Week 12 ]
    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).

  2. Change from Baseline during the Follow-up Period in worst neuroma foot pain (Diary) [ Time Frame: Baseline (mean of Day -7 through Day -1),, Week 1 through Week 12 ]
    Change from Baseline during the Follow-up Period in worst neuroma foot pain (Diary) using NPRS (mean of daily pain scores for each week).

  3. Area under the curve (AUC) for average neuroma foot pain (Diary) [ Time Frame: Baseline (mean of Day -7 through Day -1), to Week 12 ]
    Area under the curve (AUC) for average neuroma foot pain (Diary) with walking (NPRS).

  4. Foot Function measured by FFI-R-R [ Time Frame: Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12) ]
    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.

  5. 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) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283957


Locations
Layout table for location information
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
Premier Research
Phoenix, Arizona, United States, 85027
United States, Arkansas
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72410
United States, California
Center for Clinical Research, Inc
Castro Valley, California, United States, 94546
eStudySite, La Mesa
La Mesa, California, United States, 91942
TriWest Research Associates
La Mesa, California, United States, 91942
United States, Maryland
Chesapeake Research Group, LLC
Pasadena, Maryland, United States, 21122
United States, Missouri
Center for Advanced Medicine and Research
St. Peters, Missouri, United States, 63303
United States, Pennsylvania
University Orthopedics Center- Altoona
Altoona, Pennsylvania, United States, 16602
University Orthopedics Center
State College, Pennsylvania, United States, 16801
United States, Texas
Allcare Foot and Ankle Center
Arlington, Texas, United States, 76011
Premier Research
Austin, Texas, United States, 78728
Endeavor Clinical Trials, PA
San Antonio, Texas, United States, 78229
United States, Utah
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States, 84107
Jean Brown Research
Salt Lake City, Utah, United States, 84124
United States, Virginia
The Education and Research Foundation
Lynchberg, Virginia, United States, 24501
Sponsors and Collaborators
Centrexion Therapeutics

Layout table for additonal information
Responsible Party: Centrexion Therapeutics
ClinicalTrials.gov Identifier: NCT02283957     History of Changes
Other Study ID Numbers: 4975-MN-202
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroma
Morton Neuroma
Pain
Neurologic Manifestations
Signs and Symptoms
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Metatarsalgia
Foot Diseases
Musculoskeletal Diseases
Joint Diseases
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases