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Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Symptomatic Diabetic Neuropathy (SYDNEY 2) | Clinical Trials | Clareo Health

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Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Symptomatic Diabetic Neuropathy (SYDNEY 2)

Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Symptomatic Diabetic Neuropathy (SYDNEY 2) Randomised, Double-blind,Placebo-controlled Multicentre Trial With 4 Parallel Groups

NCT00328601•MEDA Pharma GmbH & Co. KG

View on ClinicalTrials.gov

Summary

The primary objective of the trial is to determine the optimal dose of orally (tablet) administered thioctic acid in the treatment of symptoms of diabetic polyneuropathy (dPNP). It is expected that at least one of the three dosages to be tested (600, 1200, or 1800 mg tablets) of orally administered thioctic acid improves the symptoms of dPNP as compared to placebo. Secondary objectives are evaluations of other variables pertinent to dPNP, safety, and tolerability.

Detailed Description

Following a screening visit, patients will receive placebo oral for 7 days. Eligible patients with chronic symptoms will then randomly be assigned to one of 4 treatment groups and treated with trial medication for 5 weeks.

Eligibility

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diabetes mellitus (Type I or II), as defined by the American Diabetes Association, 1997, lasting 1 year.
•2. Patient must have a symmetric sensory-motor peripheral polyneuropathy of at least stage 2 attributable to diabetes mellitus following a thorough evaluation for other causes of neuropathy.
•3. HbA1C \< 10%.
•4. TSS \> 7.5 points.
•5. NISLL \> 2 points.
•6. Pain sensation (according to pin-prick sensitivity test) absent or decreased (NIS item 35 1).
•8. The TSS must be \> 5 points
•9. The TSS range (maximum TSS minus minimum TSS during the run-in phase) must be less than 3 points to avoid inclusion of patients with rapidly oscillating symptoms.
•10. At least 1 of the 4 symptoms of the TSS must have occurred continuously over the last 3 months.
•11. Lack of compliance, i.e. below 85% or above 115% (Accordingly, 6 daily doses taken of the 7 daily doses scheduled for Phase A would be acceptable).

Exclusion Criteria

•Lack of suitability for the trial:
•1. Proximal asymmetric neuropathy, cranial neuropathies, truncal radiculopathy, diabetic plexopathies, or acute or active mononeuropathies (including cranial neuropathies, post-herpes neuralgias, etc.), with the exception of carpal tunnel syndrome (CTS) or tardy ulnar neuropathy (TUN) or both.
•2. Neuropathy of any cause other than diabetes mellitus which might interfere with the assessment of the severity of dPNP.
•3. Other neurologic diseases that may produce weakness, sensory loss, or autonomic symptoms or test abnormality.
•4. Myopathy of any cause.
•5. Peripheral vascular disease severe enough to cause intermittent claudication or ischemic ulcers or limb ischemia.
•6. Patients with proliferating retinopathy requiring immediately therapy and impending blindness.
•7. Psychiatric, psychological, or behavioural symptoms that would interfere with the patient's ability to participate in the trial.
•8. Patients with any active neoplastic disease except basal cell carcinoma.
•9. Patients with atrial fibrillation unless controlled and stabilised by medication.
+20 more criteria

Locations (5)

Wolfson Medical Center, Diabetes Unit

Holon, Israel

Haddassah Medical Center Ein Kerem, Diabetes Unit

Jerusalem, Israel

Chair of Nervous Diseases of IM Sechenov Moscow Medical Academy at City Clinical Hospital

Moscow, Russia

Chair of Endocrinology and Diabetology of Russian Medical Academy of Postgraduate Education at Central Clinical Hospital of Ministry of Communication RF

Moscow, Russia

Federal Centre of Medical Social Expertise and Rehabilitation of Invalids, Centre Diabetic Food

Moscow, Russia

Key Dates

Start Date

February 1, 2005

Completion Date

June 1, 2005

Last Updated

February 7, 2022

Enrollment

170

Estimated participants

Conditions

Diabetic Polyneuropathy

Interventions

Thioctic Acid

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Symptomatic Diabetic Neuropathy (SYDNEY 2)

Inclusion Criteria

Exclusion Criteria

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