Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05937152
Other study ID # 22-012864
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 2024
Est. completion date November 2025

Study information

Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 2025
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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). - 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.

Study Design


Intervention

Drug:
Eptinezumab
Intravenous (IV) infusion of 300 mg
Placebo
Intravenous (IV) infusion of placebo (looks exactly like the study drug, but it contains no active ingredients)

Locations

Country Name City State
Denmark Steno Diabetes Center Aarhus Aarhus
Denmark Steno Diabetes Center Copenhagen Copenhagen
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Countries where clinical trial is conducted

United States,  Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, 24 weeks
Secondary 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. Baseline, week 12 and week 24
Secondary Pain relief at 12 weeks Measured using a scale of complete, good, moderate, mild, none, worse 12 weeks
Secondary Pain relief at 24 weeks Measured using a scale of complete, good, moderate, mild, none, worse 24 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT06040567 - Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Completed NCT02423434 - Evaluation of Corneal Confocal Microscopy for the Identification and Prediction of Neuropathy in Type 1 Diabetes
Completed NCT05542901 - Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees N/A
Withdrawn NCT01536236 - Spinal Cord Stimulation for Diabetic Polyneuropathy N/A
Active, not recruiting NCT01175928 - Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy Phase 1/Phase 2
Completed NCT00993070 - Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy Phase 2/Phase 3
Completed NCT00539175 - Treatment of Painful Diabetic Neuropathy With Photon Stimulation N/A
Completed NCT00278980 - Effect of C-Peptide on Diabetic Peripheral Neuropathy Phase 2
Completed NCT04593992 - HTEMS Treatment of Diabetic Polyneuropathy N/A
Completed NCT01465620 - Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study Phase 3
Completed NCT01079325 - Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy Phase 2
Completed NCT00406458 - Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy Phase 2
Recruiting NCT06071975 - Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy Phase 3
Recruiting NCT06072573 - Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy Phase 3
Recruiting NCT05521737 - Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy N/A
Completed NCT01847937 - Magnetic Resonance Diagnostics of Diabetic Peripheral Neuropathy N/A
Completed NCT00476931 - Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy Phase 2
Completed NCT00977483 - Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2) Phase 3
Completed NCT01006915 - Surgical Decompression for Diabetic Neuropathy in the Foot N/A
Completed NCT00501202 - Study for Safety and Effectiveness of RWJ-333369 (Carsibamate) for the Treatment of Diabetic Peripheral Neuropathy (DPN). Phase 2

External Links