Safety and efficacy of EMA401 in patients with painful diabetic neuropathy (PDN)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

• At the time of Screening, have documented diagnosis of Type I OR Type II diabetes mellitus (DM) with painful distal symmetrical sensorimotor neuropathy (for example ICD-10 code G63.2) of more than 6 months duration with any one or more of the following:
- Neuropathic symptoms (e.g. numbness, non-painful paresthesias or tingling, non-painful sensory distortions or misinterpretations, etc.)
- Decreased distal sensation (e.g. decreased vibration, pinprick sensation, light touch, etc.)
• Be assessed as suffering from moderate to severe neuropathic pain across the Screening epoch.
• A score of = 4 on the Douleur Neuropathique en 4 Questions (DN4) questionnaire at Screening.

Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

• History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study.
• Major depressive episode within 6 months prior to Screening and/or a history of diagnosed recurrent major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria.
• Have evidence of significant renal insufficiency or pre-existing liver condition.
• Have platelets = 100 x 109/L, or neutrophil count < 1.2 x 109/L (or equivalent), hemoglobin = 100 g/L for women or hemoglobin = 110 g/L for men.
• Participants whose glycemic control has been unstable within 3 months immediately prior to screening (e.g., ketoacidosis requiring hospitalization, any recent episode of hypoglycemia requiring assistance through medical intervention, uncontrolled hyperglycemia).
• Patients with any differential diagnosis of PDN including but not limited to other neuropathies (e.g. Vitamin B12 deficiency, Chronic Inflammatory Demyelinating Polyneuropathy), polyradiculopathies, central disorders (e.g. demyelinating disease), or rheumatological disease (e.g., foot arthritis, plantar fasciitis).
• Patient is unwilling or unable to complete daily eDiary.

Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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