Painful Diabetic Neuropathy Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Randomized Trial to Determine the Safety and Efficacy of EMA401 in Reducing 24-hour Average Pain Intensity Score in Patients With Painful Diabetic Neuropathy (EMPADINE)
The purpose of this study is to evaluate safety and efficacy of EMA401 compared to placebo in patients with painful diabetic neuropathy (PDN).
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 be randomized in a 1:1 ratio to Placebo b.i.d. or EMA401 100 mg b.i.d.. Concomitant use of pregabalin or duloxetine at stable doses was allowed. Based on historical data, it was planned that the study would enroll approximately 50% of patients who were on stable doses of concomitant pregabalin or duloxetine in the study. At the end of treatment period the 100mg b.i.d. arm was re-randomized (1:1) to the same treatment or placebo. Placebo arm stayed on placebo. The planned duration of treatment period was 12 weeks and 1 week of treatment withdrawal at the end of treatment period. The study was terminated early due to pre-clinical toxicity data that became available after start of trial. Novartis implemented a Urgent Safety Measure (USM) which instructed sites to discontinue study treatment immediately and to have all patients return for additional laboratory assessments (full hematology including coagulation and clinical chemistry panel). Safety data from the USM was presented as a separate outcome measure table and not included in the Adverse Event section ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04699734 -
Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy
|
N/A | |
Recruiting |
NCT05476276 -
EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy
|
Phase 2 | |
Recruiting |
NCT05480228 -
EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA
|
Phase 2 | |
Unknown status |
NCT01125215 -
Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05937984 -
Treatment for Painful Diabetic Neuropathy
|
N/A | |
Recruiting |
NCT05080530 -
Vitamin D and Painful Diabetic Neuropathy
|
N/A | |
Completed |
NCT04005287 -
A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy
|
Phase 2 | |
Recruiting |
NCT03331614 -
An Evaluation of an SCCD on the Symptomatology of Painful DPN
|
N/A | |
Recruiting |
NCT03700528 -
The Development of Contextual Cognitive Behavioural Approach to PDN
|
N/A | |
Recruiting |
NCT04689984 -
The Benefits of Astaxanthin as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
|
Phase 2/Phase 3 | |
Recruiting |
NCT04689958 -
The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
|
Phase 2/Phase 3 | |
Recruiting |
NCT04689971 -
The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
|
Phase 2/Phase 3 | |
Completed |
NCT03749642 -
Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy
|
Phase 2 | |
Not yet recruiting |
NCT04087941 -
Efficacy and Safety of VM202 in Painful Diabetic Peripheral Neuropathy -The HOPES Trial
|
Phase 2 | |
Terminated |
NCT01129960 -
Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain
|
Phase 3 | |
Terminated |
NCT01056315 -
A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y
|
Phase 2 | |
Completed |
NCT00980746 -
Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy
|
Phase 2 | |
Completed |
NCT04786340 -
A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy
|
Phase 2 | |
Completed |
NCT03769675 -
Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation
|
N/A | |
Completed |
NCT03755934 -
Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy
|
Phase 2 |