Diabetic Neuropathies Clinical Trial
Official title:
An Open-Label, Multi-Center Study to Evaluate the Safety of Long-Term Administration of TAK-128 in Subjects With Mild to Moderate Diabetic Peripheral Neuropathy
Verified date | February 2012 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine the safety of TAK-128, once daily (QD), for treatment of diabetic peripheral neuropathy
Status | Terminated |
Enrollment | 221 |
Est. completion date | September 2006 |
Est. primary completion date | September 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Has successfully completed protocol 01-04-TL-128-003. - Female subjects of childbearing potential must be nonpregnant, nonlactating and on an acceptable form of contraception. - Must be in good health at Enrollment, as determined by a physician at the Month 6 Visit of Protocol 01-04-TL-128-003 (ie, via medical history and physical examination). - Has clinical laboratory evaluations within the normal reference range for the testing laboratory, unless the results are deemed not clinically significant by the investigator or sponsor, at the Month 6 Visit of Protocol 01-04-TL-128-003. - Has a creatinine level less than or equal to 2 mg/dL or 176.8 umol/L. - The subject is willing to follow an American Diabetes Association or similar recommended dietary regimen. Exclusion Criteria: - Has developed other neuropathies due to causes other than diabetes such as alcohol abuse liver or renal disease, uremia, toxic exposure, genetic factors, inflammatory demyelinating diseases, monoclonal gammopathies; or endocrine, metabolic or nutritional disorders (included treated or untreated pernicious anemia). - Has a systolic blood pressure greater than 160 mm HG or diastolic blood pressure is greater than 95 mm HG. - The subject has an alanine aminotransferase level of greater than 1.5 times the upper limit of normal, active liver disease, or jaundice. - Has a significant, actively treated or unstable pulmonary, cardiovascular, gastrointestinal, hepatic, hematologic, musculoskeletal, or endocrine (other than diabetes mellitus or stably treated hypothyroidism) disease. - Cannot use any of the following prescription medications throughout the duration of the study, including: - Lipoic acid. - Linolenic acid (primrose oil). - Inositol. - Topiramate. - Acetyl-L-Carnitine. - Nerve growth factors. - Capsaicin. - Has any other serious disease or condition at the Month 6 Visit of Protocol 01-04-TL-128-003 or at the Baseline/Rollover Visit that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Takeda |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment-emergent adverse events, vital signs and physical examination findings. | At each visit | Yes | |
Primary | Clinical Laboratory Tests (Hematology, Chemistry and Urinalysis). | At each visit | Yes | |
Primary | Electrocardiogram results. | At each visit | Yes | |
Primary | Weight. | At each visit | Yes | |
Secondary | Change from Baseline in composite nerve conduction velocities (Electrophysiologic Studies). | Months 6 and 12 or Final Visit | No | |
Secondary | Change from Baseline in the electrophysiologic parameters for individual nerves, including amplitudes (Nerve Conduction Studies). | Months 6 and 12 or Final Visit | No | |
Secondary | Change from Baseline in vibration perception threshold measurements (Quantitative Sensory Testing). | Month 3, 6, 9 and 12 or Final Visit | No | |
Secondary | Change from Baseline in neurological examination (Clinical Neurologic Examination). | Month 3, 6, 9 and 12 or Final Visit | No | |
Secondary | Change from Baseline in pain scores (Short-Form McGill Pain Questionnaire). | Month 3, 6, 9 and 12 or Final Visit | No | |
Secondary | Change from Baseline in quality of life index as assessed by the Short-Form, 36-Item Health Survey. | Month 3, 6, 9 and 12 or Final Visit | No |
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