Safety Study of TAK-128 in Subjects With Diabetic Peripheral Neuropathy

NCT00756041 | Terminated Phase 2

• 2 other identifiers: 01-05-TL-128-006U1111-1128-5801
• Study Type: interventional
• Target: 221
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety of TAK-128, once daily (QD), for treatment of diabetic peripheral neuropathy

Conditions

Diabetic Neuropathies

Keywords

Diabetic Mononeuropathy; Diabetic Neuralgia; Mononeuropathy, Diabetic; Neuralgia, Diabetic; Diabetic Polyneuropathy; Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Treatment-emergent adverse events, vital signs and physical examination findings.

  At each visit

• Clinical Laboratory Tests (Hematology, Chemistry and Urinalysis).

  At each visit

• Electrocardiogram results.

  At each visit

• Weight.

  At each visit

Secondary Outcomes (6)

• Change from Baseline in composite nerve conduction velocities (Electrophysiologic Studies).

  Months 6 and 12 or Final Visit

• Change from Baseline in the electrophysiologic parameters for individual nerves, including amplitudes (Nerve Conduction Studies).

  Months 6 and 12 or Final Visit

• Change from Baseline in vibration perception threshold measurements (Quantitative Sensory Testing).

  Month 3, 6, 9 and 12 or Final Visit

• Change from Baseline in neurological examination (Clinical Neurologic Examination).

  Month 3, 6, 9 and 12 or Final Visit

• Change from Baseline in pain scores (Short-Form McGill Pain Questionnaire).

  Month 3, 6, 9 and 12 or Final Visit

Study Arms (1)

TAK-128 100 mg QD

EXPERIMENTAL

Drug: TAK-128

Interventions

TAK-128 DRUG

TAK-128 100 mg tablet, orally, once daily for up to 1 year.

TAK-128 100 mg QD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Sr. Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 19, 2008
• Study Start: September 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: February 28, 2012

Record last verified: 2012-02