Painful Intermetatarsal Neuroma (Morton's Neuroma)Phase 2NCT02283957
A Study to Evaluate the Efficacy and Safety of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)
A Phase 2 study testing CNTX-4975 in people with Painful Intermetatarsal Neuroma (Morton's Neuroma), run by Centrexion Therapeutics at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Intermetatarsal Neuroma (Morton's Neuroma)
- What is being tested?
- CNTX-4975
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 16 sitesUnited States
- Study dates
- Oct 2014to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University Orthopedics Center- Altoona
Altoona, Pennsylvania, 16602
Allcare Foot and Ankle Center
Arlington, Texas, 76011
Premier Research
Austin, Texas, 78728
Center for Clinical Research, Inc
Castro Valley, California, 94546
Center for Advanced Medicine and Research
City of Saint Peters, Missouri, 63303
NEA Baptist Clinic
Jonesboro, Arkansas, 72410
eStudySite, La Mesa
La Mesa, California, 91942
TriWest Research Associates
La Mesa, California, 91942
The Education and Research Foundation
Lynchberg, Virginia, 24501
Chesapeake Research Group, LLC
Pasadena, Maryland, 21122
Arizona Research Center
Phoenix, Arizona, 85023
Premier Research
Phoenix, Arizona, 85027
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
Jean Brown Research
Salt Lake City, Utah, 84124
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229
University Orthopedics Center
State College, Pennsylvania, 16801
About this study
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 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.
- Being tested
- CNTX-4975, Placebo
- Medical subject headings
- Morton Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTX-4975Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 2 mL injection of 200 µg of CNTX-4975 | Experimental | Single dose, 2 mL Receives: Drug: CNTX-4975 |
| 2 mL injection of 600 µg of CNTX-4975 | Experimental | Single dose, 2 mL Receives: Drug: CNTX-4975 |
| 2 mL injection of placebo | Placebo comparator | Single dose, 2 mL Receives: Other: Placebo |
| 2 mL injection of 25 µg of CNTX-4975 | Experimental | Single dose, 2 mL Receives: Drug: CNTX-4975 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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)
Change from Baseline during the Follow-up Period in worst neuroma foot pain (Diary) using NPRS (mean of daily pain scores for each week).
Measured: Baseline (mean of Day -7 through Day -1),, Week 1 through Week 12
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).
Measured: Baseline (mean of Day -7 through Day -1), to Week 12
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.
Measured: Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12)
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.
Measured: Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Intermetatarsal Neuroma (Morton's Neuroma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centrexion Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283957
- Sponsor's protocol ID
- 4975-MN-202
- Status last verified
- Dec 2016
- First submitted
- 3 Nov 2014
- Last updated
- 6 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02283957
- Acronym / sponsor ID
- 4975-MN-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 mL injection of 200 µg of CNTX-4975 | Experimental | Drug: CNTX-4975Single dose, 2 mL |
| 2 mL injection of 600 µg of CNTX-4975 | Experimental | Drug: CNTX-4975Single dose, 2 mL |
| 2 mL injection of placebo | Placebo comparator | Other: PlaceboSingle dose, 2 mL |
| 2 mL injection of 25 µg of CNTX-4975 | Experimental | Drug: CNTX-4975Single dose, 2 mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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.
5 secondary outcomes
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 worst neuroma foot pain (Diary)
Time frame: Baseline (mean of Day -7 through Day -1),, Week 1 through Week 12
Area under the curve (AUC) for average neuroma foot pain (Diary)
Time frame: Baseline (mean of Day -7 through Day -1), to Week 12
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CNTX-4975 in people with Painful Intermetatarsal Neuroma (Morton's Neuroma), run by Centrexion Therapeutics at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.