Diabetic Polyneuropathy Clinical Trial
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
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 |
Verified date | May 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Steno Diabetes Center Aarhus | Aarhus | |
Denmark | Steno Diabetes Center Copenhagen | Copenhagen | |
United States | Mayo Clinic Minnesota | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States, Denmark,
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 |
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 |
NCT06072573 -
Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy
|
Phase 3 | |
Recruiting |
NCT06071975 -
Long Term 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 |