Polyneuropathy, DiabeticPhase 4MIRACLE-ALANCT05813496
Phase IV Trial to Evaluate Efficacy of Alpha-Lipoic Acid in Treating Symptomatic Diabetic Polyneuropathy in Egypt
A Phase 4 study testing Alpha-Lipoic Acid (ALA) in people with Polyneuropathy, Diabetic, run by Eva Pharma at 5 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Polyneuropathy, Diabetic
- What is being tested?
- Alpha-Lipoic Acid (ALA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 430 participants
- Where
- 5 sitesEgypt
- Study dates
- 26 Oct 2022to 11 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent form.
- Male or female patients aged ≥ 18 and ≤ 64 years.
- Type 2 diabetes mellitus (T2DM) patients as defined according to the American Diabetes Association (ADA) criteria with diabetes duration ≥ 1 year.
- Hemoglobin A1c (HbA1c) ≤10%.
- Patients with symptomatic distal symmetrical polyneuropathy (DSPN) attributable to diabetes; after a thorough evaluation for other causes of neuropathy, with evidence of polyneuropathy based on abnormal peripheral nerve function according to clinical and electrophysiological examinations.
- Patients treated with oral antidiabetic drugs and/or insulin.
- Patients with the treatment regimen, weight, diet, and physical activity level relatively acceptable as judged by the investigator within 1 month prior to study entry.
- Patients with working telephone numbers.
Who cannot join
- Female patients with child-bearing potential not using effective birth control methods including oral contraceptives with a stable regimen for at least 2 months, depo-medroxyprogesterone, a barrier method alone (diaphragm, condoms, or contraceptive sponge with spermicidals), or an intrauterine device that has been in place for at least 2 months.
- Patients with neuropathies other than DSPN; myopathy and other neurologic diseases that might interfere with the assessment of the severity of DSPN.
- Patients with a recent history of drug or alcohol abuse; within 1 year prior to study entry.
- Patients with a history of peripheral vascular disease and/or foot ulcers.
- Patients with a history of organ transplantation.
- Patients with a history of cardiovascular, pulmonary, gastrointestinal, hematologic, or endocrine disease, or malignancy that cause neuropathic pain.
Show all 14Show fewer
- Hospitalization due to hypoglycemia or ketoacidosis within 3 months prior to study entry.
- Patients with significant hepatic or renal disease [Serum creatinine > 1.8 mg/dL for men and > 1.6 mg/dL for women, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 times upper limit of normal (ULN)].
- Use of medications indicated for neuropathic pain relief within 15 days (washout period) prior to study entry. For analgesia, standard doses of salicylates, ibuprofen, indoles, fenamates, oxicams, or pyrazoles are allowed.
- Use of antioxidants (including but not limited to vitamin E, vitamin C, and β-carotene) or pentoxifylline within 1 month prior to study entry.
- Use of medications or vitamins known to cause peripheral neuropathy including but not limited to the use of phenytoin or carbamazepine over 15 or more years, or use of pyridoxine > 100 mg/d within 12 months prior to study entry.
- Use of ≥ 50 mg ALA or use of alpha-linolenic acid-containing substances within 3 months prior to study entry.
- Use of an investigational drug within 6 months prior to study entry.
- Enrollment in any other clinical trial during the time of this trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Egypt5 sites
Mansoura University Hospital
Al Mansurah
Alexandria University
Alexandria, Bab Sharqi, 21544
Beni Suef University Hospital
Banī Suwayf, Beni Suweif Governorate, 2711860
Ain-Shams University Hospital
Cairo, Heliopolis, 11588
Menoufia University Hospital
Shibīn al Kawm, Shebin El Kom
About this study
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
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.
Read the 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: Screening/Baseline 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
- Conditions
- Polyneuropathy, Diabetic
- Being tested
- Alpha-Lipoic Acid (ALA), Placebo
- Keywords
- Thiotacid, Double-blinded, Placebo-controlled, Multi-center
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Lipoic Acid (ALA)Drug
Also called Thiotacid® 600 mg
Oral tablet
PlaceboDrug
Also called Oral tablet
Microcrystalline cellulose (Ph 101) 427.5 mg, Magnesium stearate 71.25 mg, Sodium laurayl sulphate 6 mg, Croscarmellose sodium 11.25 mg, Silica, colloid anhydrous 11.25 mg, and Purified talc 30 mg.
| Study group | Role | What they receive |
|---|---|---|
| IND Arm | Experimental | 200 patients will receive one tablet of 600 mg of alpha-lipoic acid twice a day orally for 24 weeks. Receives: Drug: Alpha-Lipoic Acid (ALA) |
| Placebo Arm | Placebo comparator | 200 patients will receive one tablet of placebo twice a day orally for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the relative change in NCS parameters between the study arms
The main objective of this study is to calculate the efficacy of alpha-lipoic acid in comparison with placebo in diabetic patients with symptomatic polyneuropathy assessed by the change in NCS parameters after 4 weeks of treatment using student t-test (Mann-Whitney test for non-parametric data) to compare relative change between treatment arm and control arm. This analysis will be comparative and will be done on eligible subjects without protocol violation and who have at least one treatment dose and an evaluable primary endpoint.
Measured: After four weeks of treatment
Secondary outcomes (4)
To compare the relative change in NCS parameters between the study arms.
The efficacy of alpha-lipoic acid in comparison with placebo in diabetic patients with symptomatic polyneuropathy assessed by the change in NCS after 24 weeks of treatment using student t-test (Mann-Whitney test for non-parametric data) to compare relative change between treatment arm and control arm.
Measured: After 24 weeks of treatment
To compare the relative change in NDS and Neuro-QoL between the study arms.
The efficacy of alpha-lipoic acid in comparison with placebo in diabetic patients with symptomatic polyneuropathy as assessed by the change in NDS* total score (out of 10 = the sum of the scores for right and left sides) using student t-test (Mann-Whitney test for non-parametric data) to compare relative change between treatment and control arms.
Measured: After 24 weeks of treatment
To compare the frequency of the need to rescue analgesic medications between the study arms
The efficacy alpha-lipoic acid in comparison with placebo in diabetic patients with symptomatic polyneuropathy assessed by number of patients receiving rescue analgesic medications using chi square test to compare between treatment arm and control arm. This analysis will be comparative and will be done on eligible subjects without protocol violation and who have at least one treatment dose and evaluable primary endpoint
Measured: After 24 weeks of treatment
To assess safety of Thiotacid® as per the nature and severity of the recorded adverse events.
The safety of alpha-lipoic acid in diabetic patients with symptomatic neuropathy assessed by the number of patients experiencing AE/SAE and number of patients who discontinued study drug due to AEs. These will be described using counts/percentages with 95% CI. This analysis will be descriptive and will be conducted on all patients enrolled to the study who signed an ICF.
Measured: After 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start26 Oct 2022
- Primary completion3 Aug 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Polyneuropathy, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After signing the ICF, eligible patients were randomized in a 1:1 allocation ratio, into one of the two treatment groups, to receive either ALA or placebo. Randomization will be done using an interactive web response system (IWRS). Randomization was stratified by baseline body mass index (BMI) (\< 25 Kg/m2 or 25-40 Kg/m2) followed by age (\<45 years or ≥ 45 years) and gender (male or female).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eva Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MARC-CRO
- Responsible party
- Sponsor
- Investigators
- Samir H Assaad Khali, PhD, Principal investigator, Alexandria University Hospital / Internal MedicineMohamed R Halawa, PhD, Principal investigator, Ain-Shams University Hospital / Internal MedicineNabil AF El Kafrawy, PhD, Principal investigator, Menoufia University Hospital / Internal MedicineHanan M El Sotouhy Gawish, PhD, Principal investigator, Mansoura University Hospital / Internal MedicineKhaled ES El Hadidy, PhD, Principal investigator, Beni Suef University Hospital / Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813496
- Sponsor's protocol ID
- Cl_Tr_17122019
- Acronym
- MIRACLE-ALA
- Status last verified
- Mar 2025
- First submitted
- 3 Apr 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ADA. (2022). Standards of Medical Care in Diabetes-2022 Th E Jou R Nal of C Li N Ical an D Appli Ed R Esearc H an D Education. Diabetes Care, 45(Suppliment 1), S1-S264. https://doi.org/10.2337/dc22-SREV
Boulton AJ, Vinik AI, Arezzo JC, Bril V, Feldman EL, Freeman R, Malik RA, Maser RE, Sosenko JM, Ziegler D; American Diabetes Association. Diabetic neuropathies: a statement by the American Diabetes Association. Diabetes Care. 2005 Apr;28(4):956-62. doi: 10.2337/diacare.28.4.956. No abstract available.
PubMed 15793206Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
PubMed 27999003Roman-Pintos LM, Villegas-Rivera G, Rodriguez-Carrizalez AD, Miranda-Diaz AG, Cardona-Munoz EG. Diabetic Polyneuropathy in Type 2 Diabetes Mellitus: Inflammation, Oxidative Stress, and Mitochondrial Function. J Diabetes Res. 2016;2016:3425617. doi: 10.1155/2016/3425617. Epub 2016 Dec 12.
PubMed 28058263Type 2 diabetes in adults: management. (2022). Type 2 Diabetes in Adults: Management, March. https://www.ncbi.nlm.nih.gov/books/NBK553486/
Young MJ, Boulton AJ, MacLeod AF, Williams DR, Sonksen PH. A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. Diabetologia. 1993 Feb;36(2):150-4. doi: 10.1007/BF00400697.
PubMed 8458529Ziegler D, Gries FA. Alpha-lipoic acid in the treatment of diabetic peripheral and cardiac autonomic neuropathy. Diabetes. 1997 Sep;46 Suppl 2:S62-6. doi: 10.2337/diab.46.2.s62.
PubMed 9285502
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05813496
- Acronym / sponsor ID
- MIRACLE-ALA / Cl_Tr_17122019
- Conditions
- Polyneuropathy, Diabetic
- Keywords
- Thiotacid, Double-blinded, Placebo-controlled, Multi-center
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Eva PharmaIndustry (pharma, biotech, devices)
- Collaborators
- MARC-CRO
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 3 Aug 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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: Screening/Baseline 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- After signing the ICF, eligible patients were randomized in a 1:1 allocation ratio, into one of the two treatment groups, to receive either ALA or placebo. Randomization will be done using an interactive web response system (IWRS). Randomization was stratified by baseline body mass index (BMI) (< 25 Kg/m2 or 25-40 Kg/m2) followed by age (<45 years or ≥ 45 years) and gender (male or female).
| Arm | Type | Receives |
|---|---|---|
| IND Arm | Experimental | Drug: Alpha-Lipoic Acid (ALA)200 patients will receive one tablet of 600 mg of alpha-lipoic acid twice a day orally for 24 weeks. |
| Placebo Arm | Placebo comparator | Drug: Placebo200 patients will receive one tablet of placebo twice a day orally for 24 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed informed consent form.
- Male or female patients aged ≥ 18 and ≤ 64 years.
- Type 2 diabetes mellitus (T2DM) patients as defined according to the American Diabetes Association (ADA) criteria with diabetes duration ≥ 1 year.
- Hemoglobin A1c (HbA1c) ≤10%.
- Patients with symptomatic distal symmetrical polyneuropathy (DSPN) attributable to diabetes; after a thorough evaluation for other causes of neuropathy, with evidence of polyneuropathy based on abnormal peripheral nerve function according to clinical and electrophysiological examinations.
Key exclusion criteria (14 listed)
- Female patients with child-bearing potential not using effective birth control methods including oral contraceptives with a stable regimen for at least 2 months, depo-medroxyprogesterone, a barrier method alone (diaphragm, condoms, or contraceptive sponge with spermicidals), or an intrauterine device that has been in place for at least 2 months.
- Patients with neuropathies other than DSPN; myopathy and other neurologic diseases that might interfere with the assessment of the severity of DSPN.
- Patients with a recent history of drug or alcohol abuse; within 1 year prior to study entry.
- Patients with a history of peripheral vascular disease and/or foot ulcers.
- Patients with a history of organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-Lipoic Acid (ALA)Also: Thiotacid® 600 mgOral tablet | Drug | IND Arm |
| PlaceboAlso: Oral tabletMicrocrystalline cellulose (Ph 101) 427.5 mg, Magnesium stearate 71.25 mg, Sodium laurayl sulphate 6 mg, Croscarmellose sodium 11.25 mg, Silica, colloid anhydrous 11.25 mg, and Purified talc 30 mg. | Drug | Placebo Arm |
Primary outcome
To compare the relative change in NCS parameters between the study arms
Time frame: After four weeks of treatment
The main objective of this study is to calculate the efficacy of alpha-lipoic acid in comparison with placebo in diabetic patients with symptomatic polyneuropathy assessed by the change in NCS parameters after 4 weeks of treatment using student t-test (Mann-Whitney test for non-parametric data) to compare relative change between treatment arm and control arm. This analysis will be comparative and will be done on eligible subjects without protocol violation and who have at least one treatment dose and an evaluable primary endpoint.
4 secondary outcomes
To compare the relative change in NCS parameters between the study arms.
Time frame: After 24 weeks of treatment
To compare the relative change in NDS and Neuro-QoL between the study arms.
Time frame: After 24 weeks of treatment
To compare the frequency of the need to rescue analgesic medications between the study arms
Time frame: After 24 weeks of treatment
To assess safety of Thiotacid® as per the nature and severity of the recorded adverse events.
Time frame: After 24 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- BackgroundADA. (2022). Standards of Medical Care in Diabetes-2022 Th E Jou R Nal of C Li N Ical an D Appli Ed R Esearc H an D Education. Diabetes Care, 45(Suppliment 1), S1-S264. https://doi.org/10.2337/dc22-SREV
- Background: PubMed 15793206Boulton AJ, Vinik AI, Arezzo JC, Bril V, Feldman EL, Freeman R, Malik RA, Maser RE, Sosenko JM, Ziegler D; American Diabetes Association. Diabetic neuropathies: a statement by the American Diabetes Association. Diabetes Care. 2005 Apr;28(4):956-62. doi: 10.2337/diacare.28.4.956. No abstract available.
- Background: PubMed 27999003Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
- Background: PubMed 28058263Roman-Pintos LM, Villegas-Rivera G, Rodriguez-Carrizalez AD, Miranda-Diaz AG, Cardona-Munoz EG. Diabetic Polyneuropathy in Type 2 Diabetes Mellitus: Inflammation, Oxidative Stress, and Mitochondrial Function. J Diabetes Res. 2016;2016:3425617. doi: 10.1155/2016/3425617. Epub 2016 Dec 12.
- BackgroundType 2 diabetes in adults: management. (2022). Type 2 Diabetes in Adults: Management, March. https://www.ncbi.nlm.nih.gov/books/NBK553486/
- Background: PubMed 8458529Young MJ, Boulton AJ, MacLeod AF, Williams DR, Sonksen PH. A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. Diabetologia. 1993 Feb;36(2):150-4. doi: 10.1007/BF00400697.
- Background: PubMed 9285502Ziegler D, Gries FA. Alpha-lipoic acid in the treatment of diabetic peripheral and cardiac autonomic neuropathy. Diabetes. 1997 Sep;46 Suppl 2:S62-6. doi: 10.2337/diab.46.2.s62.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir H Assaad Khali, PhD principal investigator
Alexandria University Hospital / Internal Medicine
Mohamed R Halawa, PhD principal investigator
Ain-Shams University Hospital / Internal Medicine
Nabil AF El Kafrawy, PhD principal investigator
Menoufia University Hospital / Internal Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alpha-Lipoic Acid (ALA) in people with Polyneuropathy, Diabetic, run by Eva Pharma at 5 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the relative change in NCS parameters between the study arms (time frame: After four weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05813496, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.