Diabetic PolyneuropathyPhase 2NCT05937152
A Study of CGRP Monoclonal Antibody to Treat Diabetic Neuropathy
A Phase 2 study testing Eptinezumab in people with Diabetic Polyneuropathy, run by Mayo Clinic at 3 sites in 2 countries.
Trial summary
The main purpose of this study is to compare the change in pain intensity during treatment with a CGRP monoclonal antibody (eptinezumab) compared with placebo treatment in patients with painful diabetic polyneuropathy (DPN). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- Eptinezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2025to Nov 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of probable diabetic polyneuropathy, as defined by the Toronto consensus criteria and a TCNS > 5 or abnormal DPNCheck or abnormal NCS.
- Probable neuropathic pain as defined by the NeuPSIG guidelines.
- Symmetric distal pain worse in the distal lower extremities present for > 6 months.
- Average pain score on a NRS of ≥ 4 during the baseline week.
Who cannot join
- Prior or current use of a CGRP mAbs or CGRP antagonists.
- Opioid regimen other than stable low dose of Tramadol (maximum 200 mg/day).
- The patient has a lifetime history of psychosis, bipolar mania, or dementia. Patients with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded.
- Initiation of new neuropathic pain medications such as gabapentinoid medications (gabapentin, pregabalin) and/or capsaicin (Quetenza), botulinum toxin type A, serotonin/norepinephrine reuptake inhibitors (TCA or duloxetine or venlafaxine) 1 month prior to enrollment or for the duration of the randomized placebo-controlled phase of the study. Current and ongoing pain treatment will be allowed in stable dose (anticonvulsants, antidepressants, tramadol, topical treatments (excluding high dose capsaicin patch and botulinum toxin type A) (Paracetamol 1g and over-the-counter NSAIDS as needed up to four times daily are allowed as rescue medicine).
- Suspected cause of lower extremity pain of other causes than diabetes (e.g., chemotherapy, alcohol or drug misuse, vitamin deficiency, concomitant central nervous system pathology) or patients with pain that cannot be distinguished from their neuropathic pain in the feet due to diabetes.
- The patient has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
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- The patient has a BMI ≥ 39 kg/m^2 at the screening visit.
- Peripheral arterial disease (PAD) defined as toe pressure < 40mmHg, no palpable foot pulses or clinical claudicatio intermittens.
- Chronic wounds.
- Planned larger surgery in the treatment period.
- Unable to understand Danish (Danish site only).
- All female subjects of childbearing potential must have negative result of a serum pregnancy test performed at screening. Subjects of childbearing potential must agree to use a medically approved form of birth control (abstinence, intrauterine device (IUD), oral contraception, barrier and spermicide or hormonal implant) throughout the duration of the study.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Denmark2 sites
Steno Diabetes Center Aarhus
Aarhus
Steno Diabetes Center Copenhagen
Copenhagen
About this study
Official title: CAT-Trial: CGRP Monoclonal Antibody for Treatment of Painful Diabetic Neuropathy: a Double-blind, Randomized, Placebo-controlled, International Multicenter, Phase II Clinical Trial
The main purpose of this study is to compare the change in pain intensity during treatment with a CGRP monoclonal antibody (eptinezumab) compared with placebo treatment in patients with painful diabetic polyneuropathy (DPN).
Read the detailed description
In neuropathy (nerve inflammation), which is seen in diabetes and other types of damage to the nerves, pain often occurs that can be difficult to treat. Some drugs have some effect on these pains, but unfortunately the treatment is not equally effective for all patients. It is not known why some patients achieve good pain relief with a given treatment. CGRP monoclonal antibody (eptinezumab) was originally developed as a drug for migraine and works by blocking molecules called CGRP that we, based on previous studies, play a major role in pain perception. Our previous studies have shown that patients with painful diabetic neuropathy (DPN) have increased incidence of the CGRP molecules in the skin precisely where patients experience pain compared to patients with painless DPN and healthy people without neuropathy. Eptinezumab is a Food and Drug Administration (FDA) approved drug for migraines, but it is not an approved drug for the treatment of DPN. The purpose of the trial is to investigate whether the treatment has an effect on the pain in the feet experienced by some patients with diabetes.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- Eptinezumab, Placebo
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EptinezumabDrug
Intravenous (IV) infusion of 300 mg
PlaceboDrug
Intravenous (IV) infusion of placebo (looks exactly like the study drug, but it contains no active ingredients)
| Study group | Role | What they receive |
|---|---|---|
| Eptinezumab Group | Experimental | Subjects diagnosed with diabetic polyneuropathy (DPN) will receive 2 infusions of eptinezumab during the 24 week-long placebo-controlled treatment period. Receives: Drug: Eptinezumab |
| Placebo Group | Placebo comparator | Subjects diagnosed with diabetic polyneuropathy (DPN) will receive 2 infusions of placebo during the 24-week long placebo-controlled treatment period. Receives: Drug: Placebo |
| Open-label Eptinezumab Group | Experimental | At the end of the placebo-controlled treatment period, all participants will have the option to continue into the 24-week long active study treatment period and will receive 2 infusions of eptinezumab. Receives: Drug: Eptinezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
Weekly self-reported mean pain intensity (mean pain over the last 24 h recorded every morning in every fourth week in a diary) by the average numerical rating scale (NRS) on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Measured: Baseline, 24 weeks
Secondary outcomes (3)
Change in Neuropathic Pain Severity
Measured by the total score of Neuropathic Pain Scale (NPS) on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Measured: Baseline, week 12 and week 24
Pain relief at 12 weeks
Measured using a scale of complete, good, moderate, mild, none, worse
Measured: 12 weeks
Pain relief at 24 weeks
Measured using a scale of complete, good, moderate, mild, none, worse
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study startJan 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narayan R. Kissoon, Mayo Clinic
- Investigators
- Narayan Kissoon, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937152
- Sponsor's protocol ID
- 22-012864
- Status last verified
- Mar 2025
- First submitted
- 30 Jun 2023
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAT-Trial: CGRP Monoclonal Antibody for Treatment of Painful Diabetic Neuropathy: a Double-blind, Randomized, Placebo-controlled, International Multicenter, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT05937152
- Acronym / sponsor ID
- 22-012864
- Conditions
- Diabetic Polyneuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 10 Jul 2023 (actual)
- 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 main purpose of this study is to compare the change in pain intensity during treatment with a CGRP monoclonal antibody (eptinezumab) compared with placebo treatment in patients with painful diabetic polyneuropathy (DPN).
Detailed description
In neuropathy (nerve inflammation), which is seen in diabetes and other types of damage to the nerves, pain often occurs that can be difficult to treat. Some drugs have some effect on these pains, but unfortunately the treatment is not equally effective for all patients. It is not known why some patients achieve good pain relief with a given treatment. CGRP monoclonal antibody (eptinezumab) was originally developed as a drug for migraine and works by blocking molecules called CGRP that we, based on previous studies, play a major role in pain perception. Our previous studies have shown that patients with painful diabetic neuropathy (DPN) have increased incidence of the CGRP molecules in the skin precisely where patients experience pain compared to patients with painless DPN and healthy people without neuropathy. Eptinezumab is a Food and Drug Administration (FDA) approved drug for migraines, but it is not an approved drug for the treatment of DPN. The purpose of the trial is to investigate whether the treatment has an effect on the pain in the feet experienced by some patients with diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eptinezumab Group | Experimental | Drug: EptinezumabSubjects diagnosed with diabetic polyneuropathy (DPN) will receive 2 infusions of eptinezumab during the 24 week-long placebo-controlled treatment period. |
| Placebo Group | Placebo comparator | Drug: PlaceboSubjects diagnosed with diabetic polyneuropathy (DPN) will receive 2 infusions of placebo during the 24-week long placebo-controlled treatment period. |
| Open-label Eptinezumab Group | Experimental | Drug: EptinezumabAt the end of the placebo-controlled treatment period, all participants will have the option to continue into the 24-week long active study treatment period and will receive 2 infusions of eptinezumab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of probable diabetic polyneuropathy, as defined by the Toronto consensus criteria and a TCNS > 5 or abnormal DPNCheck or abnormal NCS.
- Probable neuropathic pain as defined by the NeuPSIG guidelines.
- Symmetric distal pain worse in the distal lower extremities present for > 6 months.
- Average pain score on a NRS of ≥ 4 during the baseline week.
Key exclusion criteria (12 listed)
- Prior or current use of a CGRP mAbs or CGRP antagonists.
- Opioid regimen other than stable low dose of Tramadol (maximum 200 mg/day).
- The patient has a lifetime history of psychosis, bipolar mania, or dementia. Patients with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded.
- Initiation of new neuropathic pain medications such as gabapentinoid medications (gabapentin, pregabalin) and/or capsaicin (Quetenza), botulinum toxin type A, serotonin/norepinephrine reuptake inhibitors (TCA or duloxetine or venlafaxine) 1 month prior to enrollment or for the duration of the randomized placebo-controlled phase of the study. Current and ongoing pain treatment will be allowed in stable dose (anticonvulsants, antidepressants, tramadol, topical treatments (excluding high dose capsaicin patch and botulinum toxin type A) (Paracetamol 1g and over-the-counter NSAIDS as needed up to four times daily are allowed as rescue medicine).
- Suspected cause of lower extremity pain of other causes than diabetes (e.g., chemotherapy, alcohol or drug misuse, vitamin deficiency, concomitant central nervous system pathology) or patients with pain that cannot be distinguished from their neuropathic pain in the feet due to diabetes.
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 |
|---|---|---|
| EptinezumabIntravenous (IV) infusion of 300 mg | Drug | Eptinezumab Group, Open-label Eptinezumab Group |
| PlaceboIntravenous (IV) infusion of placebo (looks exactly like the study drug, but it contains no active ingredients) | Drug | Placebo Group |
Primary outcome
Change in pain intensity
Time frame: Baseline, 24 weeks
Weekly self-reported mean pain intensity (mean pain over the last 24 h recorded every morning in every fourth week in a diary) by the average numerical rating scale (NRS) on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
3 secondary outcomes
Change in Neuropathic Pain Severity
Time frame: Baseline, week 12 and week 24
Pain relief at 12 weeks
Time frame: 12 weeks
Pain relief at 24 weeks
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
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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.
Narayan Kissoon, MD principal investigator
Mayo Clinic
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eptinezumab in people with Diabetic Polyneuropathy, run by Mayo Clinic at 3 sites in 2 countries.
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 4 inclusion and 12 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: withdrawn, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, 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 was withdrawn before enrolling participants, so there are no results.
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 in pain intensity (time frame: Baseline, 24 weeks). 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 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.