Phase
Condition
Neuropathy
Diabetic Neuropathy
Peripheral Neuropathy
Treatment
N/AClinical Study ID
Ages 40-95 All Genders
Study Summary
Eligibility Criteria
Inclusion
<p>Inclusion Criteria:</p><ul><li>Have a Visual Analog Scale (VAS) pain value ≥40 and <95 at screening.</li><li>Presence of painful distal sensory polyneuropathy (DSP) without prominent motor or autonomic features with gradual or insidious onset with a minimum duration of 6 months and a known cause of nerve injury, such as metabolic, toxic exposure, nutritional, immunologic, infectious, hereditary, multifactorial, or no known cause identified (idiopathic), of symmetrical nature and in lower extremities.</li><li>Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain- relieving therapies and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements during study participation.</li><li>Are willing to discontinue all medications taken for chronic pain conditions, except the allowed pain medications.</li><li>Individuals NOT of childbearing potential may participate in the trial. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.</li></ul
Exclusion
><p>Exclusion Criteria:</p><ul><li>History of other potential causative and/or confounding sources of pain that may impair self-assessment of pain due to painful DSP.</li><li>Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest.</li><li>Have not achieved glycemic control on a stable diabetes treatment regimen for at least 90 days prior to screening and have a hemoglobin A1c (HbA1c) >11 at screening.</li><li>Cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision, or cancer treatment which led to chemotherapy-induced peripheral neuropathy.</li><li>Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.</li><li>Have a surgery planned during the study for any reason.</li><li>History of chronic alcohol, illicit drug, or narcotic use disorder within 2 years prior to screening.</li></ul>
Study Design
Study Description
Connect with a study center
Mid Hudson Medical Research, PLLC
New Windsor, New York 12553
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.