Patients with Small Fiber Neuropathy and Impaired Glucose Intolerance
Trial Status
Open for Enrollment
What is the Purpose of this Study?
The majority of neuropathy cases is either unknown or has no effective therapy
to cure the neuropathy. Recently, however, Impaired Glucose Tolerance (IGT)
has been known to be a frequent cause for small fiber neuropathies. This
study will investigate whether dulozetine hydrochloride (Cymbalta) is effective
in the treatment of painful neuropathic symptoms, in patients with small
fiber neuropathy and impaired glucose tolerance.
Who is Eligible to Participate?
Patients diagnosed with Small Fiber Neuropathy with Impaired Glucose Tolerance.
Patients must also meet all other inclusion and exclusion criteria explained
in further detail by study coordinator
What is involved in this Study?
This is a placebo controlled double blind cross over study. Patients will be
randomized into a 1:1 treatment design. Group 1 will receive dulozetine 30
mg a day for 1 week, then 60 mg a day for 5 weeks. Group 2 will receive placebo
for these 6 weeks. There will then be a one week “washout period” and
the two groups will switch treatments. This will be done as a double blind
placebo controlled design.
How long is the Study?
The study will be approximately 21 weeks long. You will be taking study
medication for 6 weeks on, one week of washout, and 6 weeks off.
For More Information Contact: Nicole C. Hank, MHSM, study coordinator, at
602-258-3354 ext 137 or nhank@pnal.net or call the Main line at 602-258-3354
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