Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05813496
Status:
RECRUITING
Last Update Posted:
2023-04-14
First Post:
2023-04-03
Brief Title:
Phase IV Trial to Evaluate Efficacy of Alpha-Lipoic Acid in Treating Symptomatic Diabetic Polyneuropathy in Egypt
Sponsor:
Eva Pharma
Organization:
Eva Pharma
Study Overview
Official Title:
A Multicenter Interventional Two-arm Parallel-group Randomized Double-blinded Placebo-controlled Phase IV Trial to Evaluate the Efficacy of Alpha-Lipoic Acid in the Treatment of Symptomatic Diabetic Polyneuropathy in Egypt
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIRACLE-ALA
Brief Summary:
The purpose of the study is to find out whether ALA is effective and safe for treating Egyptian diabetic patients with symptomatic polyneuropathy The ADA stated that despite the exploration of several pharmacological therapies for DPN management substantial evidence on medicines that modify the natural history of DPN is still absent This is a multicenter interventional two-arm parallel-group randomized double-blinded placebo-controlled phase IV trial Patients will be administered either one tablet of placebo or one tablet containing 600 mg of ALA twice a day for 24 weeks depending on the randomization process
Detailed Description:
This is a multicenter interventional two-arm parallel-group randomized double-blinded placebo-controlled phase IV trial to evaluate the efficacy and safety of ALA in the treatment of diabetic patients with symptomatic polyneuropathy in Egypt
Patients will be randomly assigned to receive either
One tablet of 600 mg ALA twice a day orally for 24 weeks Total daily dose during the study duration 24 weeks 1200 mg or
One tablet of placebo twice a day orally for 24 weeks
The standard of Care SOC treatments will be prescribed for both study arms Experimental and control arm as per the routine clinical practice and following the relevant clinical guidelines The SOC treatments include those for glycemic control and other treatments for the management of painful diabetic polyneuropathy when needed through the course of the clinical study As per the ADA and NICE guidelines ADA 2022 Type 2 Diabetes Adults Manag 2022 Pregabalin Duloxetine or Gabapentin are recommended as initial pharmacologic treatments for neuropathic pain in diabetes
Estimated recruitment period 24 weeks Estimated duration of participation 24 weeks of treatment in addition to a screening period of approximately 1 week Visit 1 ScreeningBaseline visit Visit 2 After 4 weeks 5 days of treatment Visit 3 Phone call 1 After 12 weeks 15 days of treatment Visit 4 Phone call 2 After 20 weeks 15 days of treatment Visit 5 After 24 weeks 15 days of treatment
Patients will be randomly assigned to receive either
One tablet of 600 mg ALA twice a day orally for 24 weeks Total daily dose during the study duration 24 weeks 1200 mg or
One tablet of placebo twice a day orally for 24 weeks
The standard of Care SOC treatments will be prescribed for both study arms Experimental and control arm as per the routine clinical practice and following the relevant clinical guidelines The SOC treatments include those for glycemic control and other treatments for the management of painful diabetic polyneuropathy when needed through the course of the clinical study As per the ADA and NICE guidelines ADA 2022 Type 2 Diabetes Adults Manag 2022 Pregabalin Duloxetine or Gabapentin are recommended as initial pharmacologic treatments for neuropathic pain in diabetes
Estimated recruitment period 24 weeks Estimated duration of participation 24 weeks of treatment in addition to a screening period of approximately 1 week Visit 1 ScreeningBaseline visit Visit 2 After 4 weeks 5 days of treatment Visit 3 Phone call 1 After 12 weeks 15 days of treatment Visit 4 Phone call 2 After 20 weeks 15 days of treatment Visit 5 After 24 weeks 15 days of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None