Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2)

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetic Polyneuropathy

In brief

To assess clinical efficacy and safety of long-term orally administered thioctic acid in the treatment of diabetic polyneuropathy.

Key facts

Study ID

NCT00977483

Run by

MEDA Pharma GmbH & Co. KG

People needed

460

Starts

1998-05-01

Expected to finish

2005-01-01

Last updated by the study team

2022-02-07

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed Informed Consent. Patients must have willingness and complete competence to cooperate and language barriers must not preclude adequate understanding
• Diabetes mellitus (Type I or II), as defined by the American Diabetes Association 1997, lasting > 1 year
• Males or females 18 to 64 years (older patients are excluded because of age-related changes in reflexes, quantitative sensory testing endpoints, and nerve conduction endpoints)
• Patient must have a symmetric sensory-motor peripheral polyneuropathy attributable to diabetes mellitus following a thorough evaluation for other causes of neuropathy determined by performing complete medical and neurological examinations including physical and neurological history, history of medications, history of exposure to other toxins, and laboratory studies
• Severity of diabetic polyneuropathy must be Stage 1 or 2a
• Insulin regimen, weight, diet, and activity level must be relatively stable in the opinion of the investigator (for example, HbA1C must not vary by more than ± 2 Vol.% within 6 months preceding the study i.e. if the index measure = 10% the range would be 8-12%)
• NIS[LL]+7 tests ≥ 97.5 percentiles (corresponding to 4.43 transformed score points)
• NIS[LL] ≥ 2 points (NIS[LL] is based on questions 17-24, 28, 29, 34, 35, and 37 of the NIS)
• One of the following:
• an abnormality of nerve conduction attributes in two separate nerves, i.e. ≥99th percentile for DL or ≤1st percentile for NCV or amplitude or
• an abnormality of HRDB, i.e. ≤ 1st percentile
• TSS (feet) ≤5
• Females must either be surgically sterilised (tubal ligation, bilateral oophorectomy, or hysterectomy) or at least 1 year postmenopausal or practicing an acceptable method of contraception, including oral contraceptives with a stable regimen for at least two months, depo-medroxyprogesterone, a barrier method alone (diaphragm, condoms, or contraceptive sponge with spermicidals), or an IUD that has been in place for at least two months

You may not qualify if…

• Patients with proximal asymmetric neuropathy, cranial neuropathies, truncal radiculopathy, pan dysautonomia, diabetic plexopathies, or acute or active mononeuropathies (including cranial neuropathies, post-herpetic neuralgias, etc.), the presence of which might obscure accurate assessment of severity of the diabetic polyneuropathy under assessment, 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 which might interfere with the assessment of the severity of dPNP Myopathy of any cause which might interfere with the assessment of the severity of dPNP
• Peripheral vascular disease severe enough to cause intermittent claudication or ischemic ulcers or limb ischemia
• Patients with a history of ophthalmological findings suggesting a high risk for visual loss i.e., significant maculopathy or proliferative retinopathy
• 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 (changed to this criterion by Amendment 1)
• Patients with clinically significant cardiac, pulmonary, gastrointestinal, hematologic, 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 or ALAT >2 times normal, serum creatinine >1.8 mg/dL (>159 µmol/l) for males or >1.6 mg/dL (>141 µmol/l) for females)
• Patients with a recent history (within last 12 months) of drug or alcohol abuse
• Use of any investigational drug within the last 6 months
• History of severe or anaphylactic reaction to multiple drugs, sulfur products, or biologic products (changed to this criterion by Amendment 1)
• Ketoacidosis or hypoglycaemia within last 3 months resulting in hospital admission
• Antioxidant therapy (vitamins E > 400IU, C > 200mg, and beta-Carotene > 30mg) or pentoxyphylline within last 1 month before start of trial
• Use of evening primrose oil or any other gamma-linolenic acid containing substance within the last 3 months
• Use of thioctic acid > 50mg/day within last 3 months
• History of use of medications or vitamins known to cause peripheral neuropathy including but not limited to use of phenytoin or carbamazepine over 15 or more years, or use of pyridoxine > 100mg/d within the past 12 months
• Bilateral sural nerve biopsies
• Existing foot ulcers
• Pregnant or lactating females
• Continued use of medications listed in protocol 6.3.3 (first paragraph)
• Medication non-compliance (deviation of more than ±10% of dosages to be taken (1 tablet/day))

Where it is running

• ´Diabetes Care Center — Birmingham, Alabama, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• Medical Building — Long Beach, California, United States
• UCSD Neuromuscular Research Program — San Diego, California, United States
• University of California — San Francisco, California, United States
• Diabetes Research Center — Tustin, California, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Beth Israel Medical Center — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Health Partners Riverside Neurology Clinic — Minneapolis, Minnesota, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• University of Missouri Dept. of Neurology — Columbia, Missouri, United States
• Creighton University Diabetes Center — Omaha, Nebraska, United States
• Lovelace Scientific Resources, Inc. — Albuquerque, New Mexico, United States
• Ney York Hospital Cornell Med Center — New York, New York, United States
• East Carolina University, School of Medicine — Greenville, North Carolina, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Dallas Diabetes & Endocrine Center — Dallas, Texas, United States
• University of Texas South Western Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Diabetes & Glandular Disease Center — San Antonio, Texas, United States
• Leonard R. Strelitz Diabetes Institutes — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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