A Study To Evaluate The Effect Of Topiramate On Clinical And Electrophysiological Parameters In Subjects With Diabetic Peripheral Polyneuropathy
A Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Topiramate on Electrophysiological Parameters in Subjects With Diabetic Peripheral Polyneuropathy
1 other identifier
interventional
72
0 countries
N/A
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 safety of topiramate in this patient population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2001
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedJune 8, 2011
April 1, 2011
September 30, 2005
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in peroneal nerve conduction velocity (NCV) from baseline to the end of the double-blind phase.
Secondary Outcomes (1)
Changes from baseline to the end of the double-blind phase in NCVs of the sural sensory nerve and ulnar (motor and sensory) nerve, and changes in amplitudes and latencies of the peroneal motor, sural sensory, and ulnar nerves. Adverse event reporting.
Study Arms (1)
001
EXPERIMENTALTopiramate Increasing dosing of topiramate gradually to 200 mg daily by mouth dose maintenance for 12 weeks then decreasing dose until stopped over 12 weeks
Interventions
Increasing dosing of topiramate gradually to 200 mg daily by mouth, dose maintenance for 12 weeks, then decreasing dose until stopped over 12 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
July 1, 2001
Study Completion
January 1, 2003
Last Updated
June 8, 2011
Record last verified: 2011-04