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Diabetic PolyneuropathyPhase 3NCT00328601

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

A Phase 3 study testing Thioctic Acid in people with Diabetic Polyneuropathy, run by MEDA Pharma GmbH & Co. KG at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Diabetic Polyneuropathy
What is being tested?
Thioctic Acid
How many people
170 participants
Where
5 sitesin 2 countries
Study dates
Feb 2005to Jun 2005
Phase
Phase 3
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 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diabetes mellitus (Type I or II), as defined by the American Diabetes Association, 1997, lasting 1 year.
  • 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.
  • HbA1C < 10%.
  • TSS > 7.5 points.
  • NISLL > 2 points.
  • Pain sensation (according to pin-prick sensitivity test) absent or decreased (NIS item 35 1).
Show all 11Show fewer
  • Age range: 18 to 74 years. Inclusion criteria prior to randomisation
  • The TSS must be > 5 points
  • 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.
  • At least 1 of the 4 symptoms of the TSS must have occurred continuously over the last 3 months.
  • 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).

Who cannot join

  • Lack of suitability for the trial:
  • 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.
  • Neuropathy of any cause other than diabetes mellitus which might interfere with the assessment of the severity of dPNP.
  • Other neurologic diseases that may produce weakness, sensory loss, or autonomic symptoms or test abnormality.
  • Myopathy of any cause.
  • Peripheral vascular disease severe enough to cause intermittent claudication or ischemic ulcers or limb ischemia.
Show all 30Show fewer
  • Patients with proliferating retinopathy requiring immediately therapy and impending blindness.
  • Psychiatric, psychological, or behavioural symptoms that would interfere with the patient's ability to participate in the trial.
  • Patients with any active neoplastic disease except basal cell carcinoma.
  • Patients with atrial fibrillation unless controlled and stabilised by medication.
  • Patients with clinically significant cardiac, pulmonary, gastrointestinal, haematological, or endocrine disease (other than diabetes) that may confound interpretation of the study results or prevent the patient from completing the study.
  • Patients who have had organ transplants of any kind.
  • Patients with significant hepatic or renal disease (ASAT, ALAT or GGT >2 times normal, serum creatinine >1.8 mg/dL (>159 mmol/l) for males or >1.6 mg/dL (>141 mmol/l) for females).
  • Patients with a recent history (within last 12 months) of drug or alcohol abuse.
  • Use of any investigational drug (participation in a clinical trial) within last 1 month.
  • History of severe or anaphylactic reaction to drugs, sulfur or biologic products.
  • Recent (within last 3 months) ketoacidosis or hypoglycaemia, necessitating hospital admission.
  • Antioxidant therapy (vitamins E > 400 IU, C > 200 mg, and beta-Carotene > 30 mg) or pentoxyphylline within last 1 month before start of trial.
  • Use of thioctic acid (> 50 mg), evening primrose oil or any other gamma-linolenic acid containing substance within the last 3 months.
  • Continued use of medications listed in section 6.2.3.
  • Bilateral sural nerve biopsies.
  • Existing foot ulcers.
  • Safety concerns:
  • Pregnant or lactating females: Pregnancy as evidenced by positive b-hCG-test at screening visit or by testing performed at the study site on demand, or women of child-bearing potential not using adequate contraception.
  • History of allergic reaction to the study medication or its excipients.
  • Administrative reasons:
  • Informed Consent is not signed or the patient has not complete competence to co-operate.
  • Any language barriers that can affect adequate understanding.
  • Anticipated non-availability for study visits/procedures.
  • Vulnerable subjects (such as persons kept in detention)

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Russia3 sites

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

    Moscow, 119048

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

    Moscow, 125315

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

    Moscow, 127486

Other trials in Russia

Israel2 sites

  • Wolfson Medical Center, Diabetes Unit

    Holon, 58100

  • Haddassah Medical Center Ein Kerem, Diabetes Unit

    Jerusalem, 91120

Other trials in Israel

About this study

Official title: 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

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.

Read the 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.

Being tested
Thioctic Acid
Medical subject headings
Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thioctic AcidDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2006 (estimated)
  2. Study startFeb 2005
  3. Study completionJun 2005

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
170 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00328601
Sponsor's protocol ID
D-20557-3258
Status last verified
Jul 2008
First submitted
19 May 2006
Last updated
7 Feb 2022
Results posted
No

Publications

  • Wang PH, Lau J, Chalmers TC. Meta-analysis of effects of intensive blood-glucose control on late complications of type I diabetes. Lancet. 1993 May 22;341(8856):1306-9. doi: 10.1016/0140-6736(93)90816-y.

    PubMed 8098449

  • Inzucchi SE. Oral antihyperglycemic therapy for type 2 diabetes: scientific review. JAMA. 2002 Jan 16;287(3):360-72. doi: 10.1001/jama.287.3.360.

    PubMed 11790216

  • Collins SL, Moore RA, McQuayHJ, Wiffen P. Antidepressants and anticonvulsants for diabetic neuropathy and postherpetic neuralgia: a quantitative systematic review. J Pain Symptom Manage. 2000 Dec;20(6):449-58. doi: 10.1016/s0885-3924(00)00218-9.

    PubMed 11131263

  • Jarvis B, Coukell AJ. Mexiletine. A review of its therapeutic use in painful diabetic neuropathy. Drugs. 1998 Oct;56(4):691-707. doi: 10.2165/00003495-199856040-00016.

    PubMed 9806111

  • Rains C, Bryson HM. Topical capsaicin. A review of its pharmacological properties and therapeutic potential in post-herpetic neuralgia, diabetic neuropathy and osteoarthritis. Drugs Aging. 1995 Oct;7(4):317-28. doi: 10.2165/00002512-199507040-00007.

    PubMed 8535059

  • Cameron NE, Cotter MA. The relationship of vascular changes to metabolic factors in diabetes mellitus and their role in the development of peripheral nerve complications. Diabetes Metab Rev. 1994 Oct;10(3):189-224. doi: 10.1002/dmr.5610100302. No abstract available.

    PubMed 7835170

  • Smith AR, Shenvi SV, Widlansky M, Suh JH, Hagen TM. Lipoic acid as a potential therapy for chronic diseases associated with oxidative stress. Curr Med Chem. 2004 May;11(9):1135-46. doi: 10.2174/0929867043365387.

    PubMed 15134511

  • Cameron NE, Cotter MA, Archibald V, Dines KC, Maxfield EK. Anti-oxidant and pro-oxidant effects on nerve conduction velocity, endoneurial blood flow and oxygen tension in non-diabetic and streptozotocin-diabetic rats. Diabetologia. 1994 May;37(5):449-59. doi: 10.1007/s001250050131.

    PubMed 8056181

  • Nagamatsu M, Nickander KK, Schmelzer JD, Raya A, Wittrock DA, Tritschler H, Low PA. Lipoic acid improves nerve blood flow, reduces oxidative stress, and improves distal nerve conduction in experimental diabetic neuropathy. Diabetes Care. 1995 Aug;18(8):1160-7. doi: 10.2337/diacare.18.8.1160.

    PubMed 7587852

  • Ziegler D, Hanefeld M, Ruhnau KJ, Meissner HP, Lobisch M, Schutte K, Gries FA. Treatment of symptomatic diabetic peripheral neuropathy with the anti-oxidant alpha-lipoic acid. A 3-week multicentre randomized controlled trial (ALADIN Study). Diabetologia. 1995 Dec;38(12):1425-33. doi: 10.1007/BF00400603.

    PubMed 8786016

  • Ziegler D, Hanefeld M, Ruhnau KJ, Hasche H, Lobisch M, Schutte K, Kerum G, Malessa R. Treatment of symptomatic diabetic polyneuropathy with the antioxidant alpha-lipoic acid: a 7-month multicenter randomized controlled trial (ALADIN III Study). ALADIN III Study Group. Alpha-Lipoic Acid in Diabetic Neuropathy. Diabetes Care. 1999 Aug;22(8):1296-301. doi: 10.2337/diacare.22.8.1296.

    PubMed 10480774

  • Strokov IA, Kozlova NA, Mozolevskii IuV, Miasoedov SP, Iakhno NN. [The efficacy of the intravenous administration of the trometamol salt of thioctic (alpha-lipoic) acid in diabetic neuropathy]. Zh Nevrol Psikhiatr Im S S Korsakova. 1999;99(6):18-22. Russian.

    PubMed 10441861

  • Ametov AS, Barinov A, Dyck PJ, Hermann R, Kozlova N, Litchy WJ, Low PA, Nehrdich D, Novosadova M, O'Brien PC, Reljanovic M, Samigullin R, Schuette K, Strokov I, Tritschler HJ, Wessel K, Yakhno N, Ziegler D; SYDNEY Trial Study Group. The sensory symptoms of diabetic polyneuropathy are improved with alpha-lipoic acid: the SYDNEY trial. Diabetes Care. 2003 Mar;26(3):770-6. doi: 10.2337/diacare.26.3.770.

    PubMed 12610036

  • Ruhnau KJ, Meissner HP, Finn JR, Reljanovic M, Lobisch M, Schutte K, Nehrdich D, Tritschler HJ, Mehnert H, Ziegler D. Effects of 3-week oral treatment with the antioxidant thioctic acid (alpha-lipoic acid) in symptomatic diabetic polyneuropathy. Diabet Med. 1999 Dec;16(12):1040-3. doi: 10.1046/j.1464-5491.1999.00190.x.

    PubMed 10656234

  • Dyck PJ, Kratz KM, Lehman KA, Karnes JL, Melton LJ 3rd, O'Brien PC, Litchy WJ, Windebank AJ, Smith BE, Low PA, et al. The Rochester Diabetic Neuropathy Study: design, criteria for types of neuropathy, selection bias, and reproducibility of neuropathic tests. Neurology. 1991 Jun;41(6):799-807. doi: 10.1212/wnl.41.6.799.

    PubMed 2046920

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Thioctic Acid in people with Diabetic Polyneuropathy, run by MEDA Pharma GmbH & Co. KG at 5 sites in 2 countries.

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 11 inclusion and 30 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 7 Feb 2022. 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 Russia, Israel. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00328601, which also lists 19 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 7 Feb 2022.

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