Diabetic Peripheral Neuropathy Research Study Self-Scheduler

Qualified participants:

• Must be between 18 and 80 years old

• Must have Type 1 or 2 diabetes with A1C ≤ 9%.

• Body weight just be at least 45 kg and BMI between 18 and 40 kg/m2 [calculate here]

• Must be experiencing moderate pain in both legs or feet due to diabetic nerve damage for at least 1 year 

Answers Must Be NO: 

• Are you pregnant, breastfeeding, or planning to become pregnant during the study?

• Are you currently taking or have you recently stopped taking any of these specific pain medications: Lyrica (pregabalin), Neurontin (gabapentin), Cymbalta (duloxetine), or similar medications for nerve pain within the past 14 days? 
  • Note; participants may still be eligible to participate, IF willing and able to wash out of these meds as directed by the study team during screening. DO NOT stop taking your meds before your visit. 

• Have you been diagnosed with cancer or received cancer treatment in the past 5 years?

• Do you have severe kidney disease (stage 4 or 5) or are you on dialysis? 

• Have you had a heart attack, stroke, or been hospitalized for heart-related chest pain in the past 6 months? 

• Do you have any of these heart rhythm problems: ventricular tachycardia, ventricular fibrillation, second-degree or third-degree heart block without a pacemaker, sick sinus syndrome, or atrial fibrillation/flutter? 

• Do you have severe liver cirrhosis, current Hepatitis B or C, or detectable HIV? 

• Do you have uncontrolled high blood pressure (readings consistently above 180/110)? 

• Have you had problems with alcohol or drug abuse in the past 3 years? 

• Have you had major surgery in the past 3 months, or do you have one planned during the study period? 

• Have you been diagnosed with fibromyalgia, complex regional pain syndrome, or other chronic pain conditions not related to diabetic nerve damage? 

• Do you have a newly diagnosed severe depression, bipolar disorder, schizophrenia, or any psychiatric condition that’s not well-controlled? 

• Have you had seizure disorder or epilepsy in the past 2 years? 

• Do you have a history of ≥ stage 3 retinopathy (damage of the retina)? 

• Are you currently taking or have you taken opioid pain medications (like oxycodone, hydrocodone, morphine, fentanyl) for chronic pain (including neuropathic) or for an acute condition for >7 days in the past 3 months? 

• Do you have any intolerances or allergic reactions, contraindications to acetaminophen? 

• Are you taking any medications that affect your heart rhythm, such as: amiodarone, dronedarone, sotalol, dofetilide, quinidine, procainamide, flecainide, or propafenone? 

• Do you have a history of lower body amputation (except for toes) or non-healing skin ulcer disease? 

• Have you participated in another research study within the past 30 days? 

• Are you currently seeking or receiving disability insurance payments related to pain conditions? 

• Are you, or is anyone close to you, working on this research study at your site? 

• Have you taken Journavx? (within 30 days of screening) 

Answers Must Be YES: 

• Are you willing to stop taking your current pain medications (except acetaminophen/Tylenol) for at least 14 days before starting the study medication? 

• Are you willing and able to attend all study visits over the 14-week period? 

• If you’re a woman of childbearing potential, are you willing to use effective birth control during the study from Day 1 through 30 days after last dose of study drug?

• Are you willing to take study medication once daily and keep a daily pain diary (cell devices)?  

• Are you willing to undergo a washout (stop) use of current pain medications (minus acetaminophen)? 

• Are you willing to adjust diet to include prohibited consumption of Grapefruit or grapefruit juice, pomelos, star fruit, Seville oranges and their juices and use of st. John’s Wort throughout the study? 

PLEASE NOTE: Please confirm your eligibility before your appointment by calling 210-714-0067

• If you do not see an available appointment, please call 210-714-0067 for availability.

• Transportation may be available. Call 210-714-0067. Compensation up to $2,700 may be available for time and travel.

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