A Phase 2 Study of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (CYPRESS)

In by Hannah Schaffner

Locations
Canton, Jacksonville - LaVilla (Downtown), Macon
Condition
Diabetic Peripheral Neuropathy

A Phase 2 Study of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (CYPRESS)

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A Phase 2 Study to Evaluate the Safety and Efficacy of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Eligibility

Inclusion Criteria
  • Adult male and female subjects ≥ 18 years of age upon study consent;
  • Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) at least 1 year prior to Screening;
  • Clinical diagnosis of Diabetic Peripheral Neuropathic Pain (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);
  • Currently taking only 1 allowed prescribed standard-of-care pain medication for managing DPNP at a stable dose (not exceeding the maximum dose in the prescribing information) for approximately 4 weeks prior to Screening;
  • NPRS pain intensity score ≥ 4 on an 11-point scale at Screening.
Exclusion Criteria
  • Has neuropathy from a cause other than type 1 diabetes mellitus or type 2 diabetes mellitus;
  • 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;
  • Has had more than 1 episode of ketoacidosis or hyperosmolar state requiring hospitalization within 90 days prior to Screening;
  • Has had more than 3 episodes of hypoglycemia requiring medical assistance within 90 days prior to Screening;
  • Serum aminotransferase (alanine aminotransferase or aspartate aminotransferase) levels > 1.5× the upper limit of normal (ULN);
  • History of malignancy within 3 years prior to Screening, except for non-melanoma skin tumor, cervical carcinomas in situ, or successfully treated malignancies in remission;
  • Unwilling to practice methods of birth control during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested;
  • Women who are pregnant or breastfeeding;
  • Use of the prohibited medications, devices, or procedures.
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