Muscarinic Receptor Antagonists as a Therapy for Diabetic Neuropathy
Status:
Completed
Trial end date:
2017-12-31
Target enrollment:
Participant gender:
Summary
Investigators propose a placebo controlled, double blinded study to examine efficacy of
topical Gelnique 3%TM (3% oxybutynin) daily for 20 weeks) in improving IENF density in type 2
diabetic subjects with established peripheral neuropathy. This site most clearly demonstrated
efficacy of topiramate in reversing IENF loss within 18 weeks in our prior study. Subjects
will also undergo quantitative sensory testing (QST) and assays of laser Doppler skin blood
flow (SkBF), neuropathy total symptom score (NTSS-6), and quality of life (Norfolk QOL-DN),
along with standard measures of physiology and fasting blood chemistry. Subjects with IENF
loss of between 20-75% of normative values and thus amenable to therapy-induced recovery,
will be randomized into placebo (N=30) or active drug (N=30) arms and instructed in how to
apply 84 mg Gelnique 3%TM or hydrogel placebo to cover a 2 in2 region of skin adjacent to the
initial biopsy site, as per the manufacturers instructions (http://www.gelnique.com/gel3/).
Treatment will continue daily for 20 weeks, with monthly phone calls to monitor compliance.
After 20 weeks, subjects will return for a second series of measurements and 3 mm skin biopsy
from the treated region of skin.
Phase:
Phase 3
Details
Lead Sponsor:
Eastern Virginia Medical School
Collaborators:
Impeto Medical National Institutes of Health (NIH)