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

NCT02283957 | Completed Phase 2

• 1 other identifier: 4975-MN-202
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 16

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.

Conditions

Painful Intermetatarsal Neuroma (Morton's Neuroma)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (mean of Day -7 through Day -1), to week 4 (mean of Day 22 through Day 28)

Secondary Outcomes (5)

• Change from Baseline in average neuroma foot pain (Diary) with walking

  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)

  Baseline (mean of Day -7 through Day -1),, Week 1 through Week 12

• Area under the curve (AUC) for average neuroma foot pain (Diary)

  Baseline (mean of Day -7 through Day -1), to Week 12

• Foot Function measured by FFI-R-R

  Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12)

• QOL as measured by the EQ-5D.

  Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12)

Study Arms (4)

2 mL injection of 200 µg of CNTX-4975

EXPERIMENTAL

Single dose, 2 mL

Drug: CNTX-4975

2 mL injection of 600 µg of CNTX-4975

EXPERIMENTAL

Single dose, 2 mL

Drug: CNTX-4975

2 mL injection of placebo

PLACEBO COMPARATOR

Single dose, 2 mL

Other: Placebo

2 mL injection of 25 µg of CNTX-4975

EXPERIMENTAL

Single dose, 2 mL

Drug: CNTX-4975

Interventions

CNTX-4975 DRUG

2 mL injection of 200 µg of CNTX-4975; 2 mL injection of 25 µg of CNTX-4975; 2 mL injection of 600 µg of CNTX-4975

Placebo OTHER

2 mL injection of placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centrexion Therapeutics: lead

Study Sites (16)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Premier Research

Phoenix, Arizona, 85027, United States

Location

NEA Baptist Clinic

Jonesboro, Arkansas, 72410, United States

Location

Center for Clinical Research, Inc

Castro Valley, California, 94546, United States

Location

eStudySite, La Mesa

La Mesa, California, 91942, United States

Location

TriWest Research Associates

La Mesa, California, 91942, United States

Location

Chesapeake Research Group, LLC

Pasadena, Maryland, 21122, United States

Location

Center for Advanced Medicine and Research

City of Saint Peters, Missouri, 63303, United States

Location

University Orthopedics Center- Altoona

Altoona, Pennsylvania, 16602, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

Allcare Foot and Ankle Center

Arlington, Texas, 76011, United States

Location

Premier Research

Austin, Texas, 78728, United States

Location

Endeavor Clinical Trials, PA

San Antonio, Texas, 78229, United States

Location

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

The Education and Research Foundation

Lynchberg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Morton Neuroma

Interventions

CNTX-4975

Condition Hierarchy (Ancestors)

Metatarsalgia; Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: June 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

US (16)