Morton's NeuromaPhase 1NCT02550756
Study to Evaluate the Safety and Tolerability of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)
A Phase 1 study testing CTNX-4975 in people with Morton's Neuroma, run by Centrexion Therapeutics.
Trial summary
The purpose of this study is to confirm that the local anesthetic applied to subjects with Morton's Neuroma satisfactorily mitigates procedure pain and ensures that post-procedure discomfort or pain will not result in bias or breaking of the blind in the planned Phase 2b study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morton's Neuroma
- What is being tested?
- CTNX-4975
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Nov 2014
- Phase
- Phase 1
- 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 subjects aged >/=18 years at the time of the Screening Visit.
- Symptoms of intermetatarsal neuroma for at least 30 days prior to the Screening Visit.
- Diagnosis of intermetatarsal neuroma (Morton's neuroma) based on medical history and physical examination with evidence of focal tenderness and pain in the area of the neuroma, confirmed by ultrasound or other imaging modality. Typically the subject will have sensory symptoms in the distribution of the affected common digital nerve. However, provided the imaging study is positive, the presence of these sensory symptoms is not required. The neuroma may be in either the second or third intermetatarsal space.
- An average pain score of 4.0 to 9.0 (during the 7 days prior to dosing) on the Numeric Pain Rating Scale (NPRS), as rated daily at bedtime for average pain while walking in the last 24 hours, relevant to the affected foot. At least 4 of 7 scores during the week prior to dosing must be recorded.
- For female subjects: reproductive status is such that the subject is surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control; if of child-bearing potential, is not pregnant (negative urine pregnancy test prior to enrollment), is not planning to get pregnant during the course of the study, and is not lactating.
- Willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, pain scales, and diaries, and to communicate meaningfully with the study personnel.
- Signed an Informed Consent Form approved by the Institutional Review Board.
Who cannot join
- Clinically significant bursitis or another significant symptomatic condition in the region of or adjoining the neuroma.
- The subject has more than one intermetatarsal neuroma on the foot to be injected (index foot).
- Prior use of injection with a sclerosing agent such as alcohol or phenol, or prior surgery for intermetatarsal neuroma on the affected foot.
- Prior injection of corticosteroid in the index foot or oral use of corticosteroids within 30 days of screening.
- The subject has another painful condition that, in the judgment of the investigator, would interfere with the subject's ability to evaluate the pain and functional limitations that arise from the intermetatarsal neuroma.
- Other painful foot pathology (e.g., bunion, hammertoe, plantar fasciitis, etc.) or evidence of clinically meaningful ischemia which in the opinion of the investigator would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma. For example, if the subject has pain from a bunion but that pain is easily distinguished by the subject from the neuroma pain, then the subject would still be a candidate for the study. Note, however, that the subject should also be able to distinguish the neuroma pain from the bunion pain in terms of foot function. In general, if another foot pain condition (in the same foot) gives rise to pain that is greater than the neuroma pain, then that subject should in most instances be excluded.
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- Signs of arterial insufficiency in the feet.
- Ulcer and/or wound in the foot affected by the neuroma.
- Active cutaneous disease, or other anatomical or physiological foot disorder, at the anticipated site of study drug injection.
- History of clearly documented allergic reaction to local anesthetics or capsaicin.
- Presence of any medical condition or instability 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 laboratory result at the Screening Visit (in the opinion of the Investigator).
- Has diabetic neuropathy or other length dependent neuropathy.
- Use of any investigational medication in the 30 days prior to the current study, is scheduled to receive such an agent while participating in this study, or received a topical or injected investigational medication in the index foot within the past 60 days.
- Use of topical medication on the index foot within 7 days of screening (including lidocaine or capsaicin).
- Prior participation in an ALGRX 4975 study.
- History of substance abuse disorder within the past year as defined by DSM-IV, has current evidence for a substance abuse disorder, is receiving medicinal treatment for drug abuse, or tests positive upon urine drug screen for a substance of abuse.
- Has any condition or is taking any medication that would be contraindicated for study participation.
About this study
Official title: An Open Label, Ascending Dose Study to Evaluate the Safety and Tolerability of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)
The purpose of this study is to confirm that the local anesthetic applied to subjects with Morton's Neuroma satisfactorily mitigates procedure pain and ensures that post-procedure discomfort or pain will not result in bias or breaking of the blind in the planned Phase 2b study.
- Conditions
- Morton's Neuroma
- Being tested
- CTNX-4975
- Medical subject headings
- Morton Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTNX-4975Drug
Also called Capsaicin
| Study group | Role | What they receive |
|---|---|---|
| 0.2 mg of CNTX-4975 | Experimental | CNTX-4975 will be provided at a capsaicin concentration of 2.0 mg/ml and will be diluted to final concentration using sterile water and 30% PEG 300. Dose volume 1.0 mL-2.0 mL will be used at the discretion of the investigator. Capsaicin concentration will be 0.1 to 0.2 mg/ml Receives: Drug: CTNX-4975 |
| 0.6 mg of CNTX-4975 | Experimental | CNTX-4975 will be provided at a capsaicin concentration of 2.0 mg/ml and will be diluted to final concentration using sterile water and 30% PEG 300. Dose volume 1.0 mL-2.0 mL will be used at the discretion of the investigator. Capsaicin concentration will be 0.3 to 0.6 mg/ml Receives: Drug: CTNX-4975 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of a single injection of CNTX-4975 through assessment of incidence, intensity, relationship and seriousness of treatment-emergent adverse events
Measured: up to 6 months post injection
Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes in vital signs and laboratory tests
blood pressure, hart rate, respiration rate, body temperature, weight
Measured: up to 2 weeks post injection
Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes in sensory and motor examination of the foot
Light touch and pin prick of toes in both feet and evaluation of flexion and extension ability
Measured: up to 6 months post injection
Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes at injection site by Injection site assessment 5-point scale for erythema and edema
Measured: 1, 2, and 4 hours post injection
Secondary outcomes (3)
Evaluate the magnitude and duration of analgesic efficacy of CNTX-4975 using Numeric Pain Rating Scale (NPRS, 0-10 scale)
Measured: Up to 6 months post injection
Evaluate Patient Global Impression of Change (PGIC)
Measured: Up to 6 months post injection
Evaluate functional improvement based on Manchester Foot Pain and Disability Index (MFPDI)
Measured: 2 weeks post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morton's NeuromaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT02550756
- Sponsor's protocol ID
- 4975-MN-201
- Status last verified
- Sep 2015
- First submitted
- 14 Sep 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Ascending Dose Study to Evaluate the Safety and Tolerability of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)
- ClinicalTrials.gov ID
- NCT02550756
- Acronym / sponsor ID
- 4975-MN-201
- Conditions
- Morton's Neuroma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (actual)
- First posted
- 15 Sep 2015 (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.
The purpose of this study is to confirm that the local anesthetic applied to subjects with Morton's Neuroma satisfactorily mitigates procedure pain and ensures that post-procedure discomfort or pain will not result in bias or breaking of the blind in the planned Phase 2b study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.2 mg of CNTX-4975 | Experimental | Drug: CTNX-4975CNTX-4975 will be provided at a capsaicin concentration of 2.0 mg/ml and will be diluted to final concentration using sterile water and 30% PEG 300. Dose volume 1.0 mL-2.0 mL will be used at the discretion of the investigator. Capsaicin concentration will be 0.1 to 0.2 mg/ml |
| 0.6 mg of CNTX-4975 | Experimental | Drug: CTNX-4975CNTX-4975 will be provided at a capsaicin concentration of 2.0 mg/ml and will be diluted to final concentration using sterile water and 30% PEG 300. Dose volume 1.0 mL-2.0 mL will be used at the discretion of the investigator. Capsaicin concentration will be 0.3 to 0.6 mg/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects aged >/=18 years at the time of the Screening Visit.
- Symptoms of intermetatarsal neuroma for at least 30 days prior to the Screening Visit.
- Diagnosis of intermetatarsal neuroma (Morton's neuroma) based on medical history and physical examination with evidence of focal tenderness and pain in the area of the neuroma, confirmed by ultrasound or other imaging modality. Typically the subject will have sensory symptoms in the distribution of the affected common digital nerve. However, provided the imaging study is positive, the presence of these sensory symptoms is not required. The neuroma may be in either the second or third intermetatarsal space.
- An average pain score of 4.0 to 9.0 (during the 7 days prior to dosing) on the Numeric Pain Rating Scale (NPRS), as rated daily at bedtime for average pain while walking in the last 24 hours, relevant to the affected foot. At least 4 of 7 scores during the week prior to dosing must be recorded.
- For female subjects: reproductive status is such that the subject is surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control; if of child-bearing potential, is not pregnant (negative urine pregnancy test prior to enrollment), is not planning to get pregnant during the course of the study, and is not lactating.
Key exclusion criteria (18 listed)
- Clinically significant bursitis or another significant symptomatic condition in the region of or adjoining the neuroma.
- The subject has more than one intermetatarsal neuroma on the foot to be injected (index foot).
- Prior use of injection with a sclerosing agent such as alcohol or phenol, or prior surgery for intermetatarsal neuroma on the affected foot.
- Prior injection of corticosteroid in the index foot or oral use of corticosteroids within 30 days of screening.
- The subject has another painful condition that, in the judgment of the investigator, would interfere with the subject's ability to evaluate the pain and functional limitations that arise from the intermetatarsal neuroma.
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 |
|---|---|---|
| CTNX-4975Also: Capsaicin | Drug | 0.2 mg of CNTX-4975, 0.6 mg of CNTX-4975 |
Primary outcome
Evaluate the safety and tolerability of a single injection of CNTX-4975 through assessment of incidence, intensity, relationship and seriousness of treatment-emergent adverse events
Time frame: up to 6 months post injection
Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes in vital signs and laboratory tests
Time frame: up to 2 weeks post injection
blood pressure, hart rate, respiration rate, body temperature, weight
Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes in sensory and motor examination of the foot
Time frame: up to 6 months post injection
Light touch and pin prick of toes in both feet and evaluation of flexion and extension ability
Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes at injection site by Injection site assessment 5-point scale for erythema and edema
Time frame: 1, 2, and 4 hours post injection
3 secondary outcomes
Evaluate the magnitude and duration of analgesic efficacy of CNTX-4975 using Numeric Pain Rating Scale (NPRS, 0-10 scale)
Time frame: Up to 6 months post injection
Evaluate Patient Global Impression of Change (PGIC)
Time frame: Up to 6 months post injection
Evaluate functional improvement based on Manchester Foot Pain and Disability Index (MFPDI)
Time frame: 2 weeks post injection
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 15 Sep 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTNX-4975 in people with Morton's Neuroma, run by Centrexion Therapeutics.
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 7 inclusion and 18 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 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evaluate the safety and tolerability of a single injection of CNTX-4975 through assessment of incidence, intensity, relationship and seriousness of treatment-emergent adverse events (time frame: up to 6 months post injection). The study lists 4 primary outcomes in all. 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 15 Sep 2015.