Status:
COMPLETED
A Study To Evaluate The Effect Of Topiramate On Clinical And Electrophysiological Parameters In Subjects With Diabetic Peripheral Polyneuropathy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Diabetic Neuropathies
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the effect of topiramate on clinical and electrophysiological parameters in patients with diabetic peripheral polyneuropathy. The study will also evaluate the s...
Detailed Description
This is a multicenter, double-blind, placebo-controlled study to evaluate the effect of topiramate on clinical and electrophysiological parameters in patients with diabetic peripheral polyneuropathy. ...
Eligibility Criteria
Inclusion
- Diagnosis of type 2 diabetes mellitus
- Pain for at least 6 months prior to randomization that the investigator attributes to diabetic peripheral polyneuropathy
- Two sets of baseline nerve conduction studies and Quantitative Sensory Testing
- HbA1c =\< 9%
- Diabetes controlled on stable regimen
- Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)
Exclusion
- Diagnosis of Type 1 diabetes mellitus
- Polyneuropathy due to other underlying causes
- Hospitalization within the past 3 months due to episodes of hyper/hypoglycemia
- Other unstable medical conditions
- History of suicidal attempts
- Exposure to any other experimental drugs or device within the past 30 days
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2003
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00231673
Start Date
July 1 2001
End Date
January 1 2003
Last Update
June 8 2011
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