Peripheral Diabetic Neuropathy: A Phase 2 Study to Evaluate the Safety and Efficiency of RTA901 in Patients with Diabetic Peripheral Neuropathic Pain
Protocol Number: 901-C-2102
Sponsor: Reata™ Pharmaceuticals
Diabetic neuropathy is a common neurologic complication of both T1DM and T2DM and can lead to interference with daily activities and diminished health-related quality of life. Treatment of diabetic peripheral neuropathic pain (DPNP) involves effective glycemic control, education and counseling on foot care and safety measures, and symptomatic treatment of pain. Although numerous pathologic mechanisms contribute to DPNP, increased oxidative stress and mitochondrial dysfunction appear to be a central facilitator in its development (Fernyhough, 2010). Nonclinical data suggest that RTA 901 can improve this mitochondrial dysfunction and may offer potential therapeutic benefit to treat the pathology underlying the development of DPNP.
Summary of Study Details:
The duration of the study is 20 weeks (5 months) with 11 visits total. Most visits are scheduled approximately 2 weeks apart. There is a Screening Period of up to 4 weeks, a Treatment Period of 12 weeks, and a Follow-up Period of 4 weeks.
Pain intensity and rescue medication use will be recorded daily at bedtime in the sponsor supplied e-diary. Participants will also complete a Daily Sleep Interference Scale questionnaire upon waking from the beginning of the trial to the End-of-Study visit. All study drug will be taken at least 2 hours prior and/or 1 hour after any food intake.
Each visit will have blood collection, but there are 4 visits that require more time due to gathering pharmacokinetic (PK) data. Two visits require 4 blood draws (pre-dose, 1-hr, 2-hr and 4-hr post dose) and two visits require 2 blood draws (pre-dose, 1 hr post dose). You may leave the office and return for each blood draw.
General Eligibility Criteria:
Must have a diagnosis of Type 1 or Type 2 diabetes at least 1 year prior to enrollment, with a diagnosis of diabetic peripheral neuropathy (DPNP) for at least 6 months prior to enrollment.
Must be taking only 1 prescribed standard-of-care (SOC) pain medication (duloxetine, pregabalin, or gabapentin) at a stable dose and a single rescue medication (NSAID or acetaminophen) to treat DPNP.
Must meet certain pain intensity markers during the first 4 weeks of the trial.
Must have pain from DPNP and not another condition that could confuse the assessment of pain (i.e., fibromyalgia, or lumbar compression.)
Must test negative for central nervous system drugs (cocaine, amphetamines, marijuana)
Site Staff to make sure there participants are not taking any prohibited medications.
Compensation: Participants will be paid $50 for each regular office visit, $200 for each visit requiring 4 PK blood draws and, $100 for each visit with 2 PK blood draws for a total of $950 at study completion.
If interested in learning more, please contact our Research Coordinator, Jamie Sigg, RD,CDCES, CRC at 303-321-2644 x 214
Fernyhough P, Roy Chowdhury SK, Schmidt RE. Mitochondrial stress and the pathogenesis of diabetic neuropathy. Expert Rev Endocrinol Metab 2010;5(1):39-49.