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

NCT00229437 | Completed Phase 2

• 2 other identifiers: 01-04-TL-128-003U1111-1128-5843
• Study Type: interventional
• Target: 343
• Locations: 2 countries
• Sites: 48

Brief Summary

The purpose of this study is to determine the efficacy and safety of TAK-128, once daily (QD), in treating subjects with diabetic peripheral neuropathy.

Conditions

Diabetic Neuropathies

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in composite measure of maximal nerve conduction velocity (Nerve Conduction Studies).

  Week 24 or Final Visit

Secondary Outcomes (5)

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

  Week 24 or Final Visit

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

  Weeks 12, 24 or Final Visit

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

  Weeks: 8, 12, 16, 20, 24 or Final Visit

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

  Weeks 12, 24 or Final Visit

• Change from Baseline in quality of life index (SF-36 Health Survey).

  Weeks: 8, 12, 16, 20, 24 or Final Visit

Study Arms (4)

TAK-128 5 mg QD

EXPERIMENTAL

Drug: TAK-128

TAK-128 50 mg QD

EXPERIMENTAL

Drug: TAK-128

TAK-128 100 mg QD

EXPERIMENTAL

Drug: TAK-128

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TAK-128 DRUG

TAK-128 5 mg, tablets, orally, once daily for up to 6 months.

TAK-128 5 mg QD

Placebo DRUG

TAK-128 placebo-matching tablets, orally, once daily for up to 6 months.

Placebo 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:

• Female subjects of childbearing potential must be nonpregnant, nonlactating and on an acceptable form of contraception.
• The subject has fasting clinical laboratory evaluations within the normal reference range for the testing laboratory, or if not, the results must be deemed not clinically significant by the investigator prior to randomization.
• The subject has type 1 or 2 diabetes mellitus using World Health Organization Criteria.
• The subject has mild to moderate peripheral neuropathy defined as:
• Clinical neuropathy score greater than or equal to 2.5 on the Michigan Neuropathy Screening Instrument.
• Confirmed abnormality of at least 2 nerve conduction study velocity parameters as defined by the Neurological Core Laboratory.
• Sural sensory nerve potential amplitude greater than or equal to 1 microvolt.
• The subject's glycosylated hemoglobin is less than or equal to 10%.
• The subject is on stable diabetic therapy for at least 3 months prior to randomization.
• The subject is on stable pain medication for at least 6 weeks prior to randomization, if applicable.
• The subject's creatinine level is 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:

• The subject has a history of 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).
• The subject has clinical or electrophysiologic evidence of bilateral carpal tunnel syndrome.
• The subject has a significant skin abnormality or ulcerative changes in their lower extremities.
• The subject's body mass index is greater than 40 kg/m2.
• The subject's systolic blood pressure is greater than 160 mm Hg or diastolic blood pressure is greater than 95 mm Hg.
• The subject has a history of myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris, transient ischemic attacks, significant electrocardiograms, or documented cerebrovascular accident within 6 months prior to Screening, or is New York Heart Association Functional Cardiac Classification III or IV.
• The subject has an alanine aminotransferase level of greater than 1.5 times the upper limit of normal, active liver disease, or jaundice.
• The subject has a significant, actively treated or unstable pulmonary, gastrointestinal, hepatic, hematologic, musculoskeletal, or endocrine (other than diabetes mellitus or stably treated hypothyroidism) disease.
• The subject has a previous history of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study drug.
• The subject has taken lipoic acid, linolenic acid (primrose oil), inositol, topiramate, Acetyl-L-Carnitine, nerve growth factors, or capsaicin within 30 days prior to Screening.
• The subject has any other serious disease or condition at Screening or at randomization that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol.
• The subject has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
• The subject has a known hypersensitivity to a compound related to TAK-128.
• Subjects can not use any of the following prescription medications throughout the duration of the study, including:
• Lipoic acid

Sponsors & Collaborators

• Takeda: lead

Study Sites (48)

Unknown Facility

Mesa, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Huntington Beach, California, United States

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La Jolla, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Northridge, California, United States

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San Francisco, California, United States

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Torrance, California, United States

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Tustin, California, United States

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Aventura, Florida, United States

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Fort Myers, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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Palm Beach Gardens, Florida, United States

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Plant City, Florida, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Flint, Michigan, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Elizabeth, New Jersey, United States

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New Brunswick, New Jersey, United States

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Buffalo, New York, United States

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Staten Island, New York, United States

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Greenville, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Morrisville, Pennsylvania, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, United States

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Tacoma, Washington, United States

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Kingston, Ontario, Canada

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North Bay, Ontario, Canada

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Sarina, Ontario, Canada

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Gatineau, Quebec, Canada

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Laval, Quebec, Canada

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Québec, Quebec, Canada

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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

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 29, 2005
• Study Start: March 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (40); CA (8)