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CAT-Trial: CGRP monoclonal Antibody for Treatment of painful diabetic neuropathy: a double-blind, multicenter, placebo-controlled, international phase II clinical trial
EU CTIS ID: 2022-500338-27-00
What this study is testing
To assess the efficacy of eptinezumab on pain intensity as measured as the change in 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) (0-10) from baseline (1 week before randomization) over 24 weeks after first administration.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18 – 75 years
- 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
You likely can't join if
- Prior or current use of a CGRP mAbs or CGRP antagonists
- Planned larger surgery in the treatment period
- Chronic wounds
- 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.
- Pregnant or planning to become pregnant during the duration of the study
See the full eligibility criteria
- Age 18 – 75 years
- 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
- Prior or current use of a CGRP mAbs or CGRP antagonists
- Planned larger surgery in the treatment period
- Chronic wounds
- 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.
- Pregnant or planning to become pregnant during the duration of the study
- Opioid regimen other than stable low dose of Tramadol (maximum 200 mg/day)
- 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)
- BMI ≥39 kg/m2 at the screening visit
- Peripheral arterial disease (PAD) defined as toe pressure <40mmHg, no palpable foot pulses or clinical claudicatio intermittens
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.