Status:
TERMINATED
Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy (PDN)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate safety and efficacy of EMA401 compared to placebo in patients with painful diabetic neuropathy (PDN).
Detailed Description
This was an interventional, randomized, parallel, placebo-controlled, double-blind treatment study consisting of 3 periods i.e. Screening, Treatment, and Treatment withdrawal. Patients were planned to...
Eligibility Criteria
Inclusion
- At the time of Screening, must have had documented diagnosis of Type I OR Type II diabetes mellitus (DM) with painful distal symmetrical sensorimotor neuropathy (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.)
- Been assessed as suffering from moderate to severe neuropathic pain across the Screening epoch (NRS ≥ 4).
- A score of ≥4 on the Douleur Neuropathique en 4 Questions (DN4) questionnaire at Screening.
Exclusion
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using highly effective methods of contraception during dosing and for 3 days after stopping of study medication. Highly effective contraception methods included:
- Total abstinence (when this was is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception.
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman had been confirmed by follow up hormone level assessment.
- Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should have been the sole partner for that subject.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- 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.
- Had evidence of significant renal insufficiency or pre-existing liver condition.
- Had platelets ≤ 100 x 10\^9/L, or neutrophil count \< 1.2 x 10\^9/L (or equivalent), hemoglobin ≤ 100 g/L for women or hemoglobin ≤ 110 g/L for men.
- Participants whose glycemic control had 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 who had 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 was unwilling or unable to complete daily eDiary.
Key Trial Info
Start Date :
March 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2019
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT03297294
Start Date
March 14 2018
End Date
March 25 2019
Last Update
October 8 2021
Active Locations (64)
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1
Novartis Investigative Site
Broadmeadow, New South Wales, Australia, 2292
2
Novartis Investigative Site
Orange, New South Wales, Australia, 2800
3
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
4
Novartis Investigative Site
Heidelberg Heights, Victoria, Australia, 3081