Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Reata, a wholly owned subsidiary of Biogen
Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) at least 1 year prior to Screening
Clinical diagnosis of DPNP defined as symptomatic distal symmetric polyneuropathy (secondary to diabetes) in the lower extremities, which may include symptoms of pain that is burning, lancinating, tingling, or shooting (electric shock-like). Pain in the lower extremities may occur with paresthesia or dysesthesia (unpleasant sensations of burning). Neuropathic pain may be accompanied by an exaggerated response to painful stimuli (hyperalgesia) and pain evoked by light touch or contact, eg, with socks, shoes, and bedclothes (allodynia);
NPRS pain intensity score ≥ 4 on an 11-point scale at Screening
A score ≥ 2.5 on the Michigan Neuropathy Screening Instrument (MNSI) Part B
You may not be if
Has neuropathy from a cause other than T1DM or T2DM
Has a condition other than DPNP that could confound the assessment of pain (eg, fibromyalgia or regional pain caused by lumbar or cervical compression);
Diabetic foot ulceration or infection within 90 days prior to Screening
Prior participation in a study with RTA 901;
Clareo Health | A Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic Pain
