A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy

Completed · Phase 2 · Has a placebo group

Conditions studied: Painful Diabetic Neuropathy, Diabetes Mellitus

In brief

This is a 12 week, 2-arm, blinded, single-site, placebo-controlled Phase II study in subjects with Type II Diabetes and painful peripheral neuropathy.

Key facts

Study ID

NCT04786340

Run by

WinSanTor, Inc

People needed

58

Starts

2020-11-20

Expected to finish

2022-12-08

Last updated by the study team

2023-10-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:
• Diagnosis of T2DM (as defined by the 2016 American Diabetes Association guidelines).
• Male and female patients in the age range of 30 to 75 years (inclusive).
• Diagnosis of diabetic neuropathy (as defined by the Toronto Consensus Guidelines) of at least 12 months duration in the lower extremities.
• Provide written informed consent prior to entering the study or undergoing any study procedures.
• Females should be either not of childbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and must be practicing a highly effective medically acceptable method of contraception, including abstinence; hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device or intrauterine system; or vasectomy (partner), for at least 1 month before the screening visit and for 1 month after the end of the study. If access or use of a highly effective medically acceptable method of contraception is not achievable, then a combination of barrier methods (e.g., male condom, female condom, cervical cap, diaphragm, contraceptive sponge) is acceptable. Eligible female subjects must also have a negative serum beta-human chorionic gonadotropin at the screening visit.
• Males must use an acceptable form of contraception (e.g., male condom with diaphragm, male condom with cervical cap, or male condom in association with spermicide).
• Prior 24 hrs VAS for pain and/or altered sensations on lower extremities > 30 mm (0 mm = no pain-100 mm = very severe pain) at screening.
• Participating subjects must be reliable, willing, and able to cooperate with all study procedures, including the following:
• Return for study visits on the required dates
• Be physically able to inspect calves, tops of ankles, and soles of feet for wounds, infections, or other anomalies, and be able to self-administer the investigational drug to calves and top surface of feet.
• Be able to accurately and reliably report symptoms (including treatment-emergent signs and symptoms).
• Take study drug as required by protocol.
• Be on stable glycemic control with standard of care diabetic therapies (≥3 months prior to screening). This includes diet and exercise alone or in association with oral or injectable anti-diabetic drugs (monotherapy or combinations) that are not anticipated to change during the course of the study, except if medically required.
• Be on stable nonpharmacological pain treatment for at least 4 weeks prior to screening and remain on this stable treatment throughout the study (unless otherwise directed by a physician). Nonpharmacologic pain treatment includes the following: relaxation/hypnosis, physical or occupational therapy, counseling, etc. Episodic or periodic treatments, such as monthly injections for treatment of pain (e.g. local anesthetics) or trans electrical nerve stimulation will not be permitted.
• Regular and stable use of pharmacological pain treatment (less than or equal to 30 mg morphine equivalent) for at least 8 weeks prior to screening.
• General health status must be acceptable for participation in this 12-week clinical study, with no hospitalizations for medical conditions within 12 weeks before and during screening per judgment of the Investigator. Any question regarding eligibility will be addressed with the medical monitor.
• Fluency (oral and written) in the language in which the standardized tests will be administered.
• Exclusion:
• Subjects who meet any of the following exclusion criteria will be excluded from participating in the study:
• Severe neuropathy as determined by a UENS score > 24 at screening
• Proliferative retinopathy or maculopathy requiring acute treatment.
• Requiring dialysis.
• Impaired liver function, defined as aspartate aminotransferase or alanine aminotransferase > 3 times the upper limit of normal.
• Presence of clinically significant peripheral or autonomic neuropathy that is clearly of nondiabetic origin.

Where it is running

• Eastern Virginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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