A Phase 2 Study of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (CYPRESS) (CYPRESS)
Diabetic Peripheral Neuropathic Pain
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathic Pain focused on measuring RTA 901, Diabetic Peripheral Neuropathic Pain, DPNP
Eligibility Criteria
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.
Sites / Locations
- Arizona Research CenterRecruiting
- Hope Clinical Research, Inc.Recruiting
- Valley Research - TrialsRecruiting
- Clinical Research Institute LLCRecruiting
- Optimus Medical GroupRecruiting
- Innovative Research of West Florida, Inc.Recruiting
- Clinical Research of West Florida IncRecruiting
- Floridian Clinical ResearchRecruiting
- Finlay Medical ResearchRecruiting
- Genesis Clinical ResearchRecruiting
- Clinical Research of West Florida, Inc.Recruiting
- Baycare Clinical ResearchRecruiting
- VICIS Clinical ResearchRecruiting
- Centricity Research Columbus EndocrinologyRecruiting
- Integrated Clinical Trial Services, Inc.Recruiting
- Tandem Clinical ResearchRecruiting
- Tandem Clinical ResearchRecruiting
- Boston Clinical Trials, LLCRecruiting
- ActivMed Practices & Research, LLCRecruiting
- Revival Research Institute, LLC.Recruiting
- Clinical Research Consultants, LLCRecruiting
- Excel Clinical ResearchRecruiting
- ActivMed Practices & Research, LLCRecruiting
- Carolina Institute for Clinical ResearchRecruiting
- Diabetes & Endocrinology Associates of Stark County, Inc.Recruiting
- Remington DavisRecruiting
- WR-Notus Clinical ResearchRecruiting
- WR-ClinSearchRecruiting
- Trinity Clinical Research LLCRecruiting
- Zenos Clinical ResearchRecruiting
- Nerve and Muscle Center of TexasRecruiting
- Biopharma Informatic, LLCRecruiting
- Shadow Creek Medical ClinicRecruiting
- VIP TrialsRecruiting
- Velocity Clinical Research, Salt Lake CityRecruiting
- Rainier Clinical Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Part 1 RTA 901 Dose 1
Part 1 RTA 901 Dose 2
Part 1 Placebo
Part 2 RTA 901 Dose 1
Part 2 RTA 901 Dose 2
Part 2 Placebo
Subjects will receive study drug once daily during the 2-week Run-in Period. Following randomization, the subjects will receive a dose of RTA 901 once daily for a 12-week treatment duration.
Subjects will receive study drug once daily during the 2-week Run-in Period. Following randomization, the subjects will receive a dose of RTA 901 once daily for a 12-week treatment duration.
Subjects will receive study drug once daily during the 2-week Run-in Period. Following randomization, the subjects will receive a dose of Placebo once daily for a 12-week treatment duration.
Subjects will receive study drug once daily during the 2-week Run-in Period. Following randomization, the subjects will receive a dose of RTA 901 once daily for a 12-week treatment duration.
Subjects will receive study drug once daily during the 2-week Run-in Period. Following randomization, the subjects will receive a dose of RTA 901 once daily for a 12-week treatment duration.
Subjects will receive study drug once daily during the 2-week Run-in Period. Following randomization, the subjects will receive a dose of Placebo once daily for a 12-week treatment duration.