A Study of CGRP Monoclonal Antibody to Treat Diabetic Neuropathy

NCT05937152 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 22-012864
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 3

Brief 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).

Conditions

Diabetic Polyneuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Neuropathic Pain Severity

  Baseline, week 12 and week 24

• Pain relief at 12 weeks

  12 weeks

• Pain relief at 24 weeks

  24 weeks

Study Arms (3)

Eptinezumab Group

EXPERIMENTAL

Subjects diagnosed with diabetic polyneuropathy (DPN) will receive 2 infusions of eptinezumab during the 24 week-long placebo-controlled treatment period.

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.

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.

Drug: Eptinezumab

Interventions

Eptinezumab DRUG

Intravenous (IV) infusion of 300 mg

Eptinezumab Group; Open-label Eptinezumab Group

Placebo DRUG

Intravenous (IV) infusion of placebo (looks exactly like the study drug, but it contains no active ingredients)

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Steno Diabetes Center Aarhus

Aarhus, Denmark

Location

Steno Diabetes Center Copenhagen

Copenhagen, Denmark

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Narayan Kissoon, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: January 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); DK (2)