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RTA 901 for Diabetic Neuropathy (CYPRESS Trial)
Verified Trial
Phase 2
Recruiting
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Summary
This trial is testing a new drug called RTA 901 to see if it can help people with nerve pain caused by diabetes. The drug likely works by calming down the nerves that are causing the pain. The study will compare different doses of the drug to find out which dose works best.
Who is the study for?
Adults over 18 with type 1 or type 2 diabetes for at least a year and suffering from diabetic nerve pain in the lower extremities can join. They must have a certain level of pain despite taking one standard pain medication. Pregnant women, those not using birth control, people with recent severe liver issues, cancer history, frequent hypoglycemia needing medical help, or other major health problems are excluded.
What is being tested?
The trial is testing RTA 901 against a placebo to see if it's safe and effective for diabetic nerve pain. Participants will be randomly assigned to receive either RTA 901 at two different doses or a placebo during the study which lasts about 20 weeks including screening, treatment period and follow-up.
What are the potential side effects?
While specific side effects of RTA 901 aren't listed here, common ones in trials may include nausea, headache, dizziness or allergic reactions. The severity varies among individuals and compared to the placebo effect.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I was diagnosed with diabetes more than a year ago.
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I have diabetes-related nerve pain in my legs or feet that feels burning or electric.
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I am on a stable dose of one standard pain medication for my nerve pain.
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Your pain score is 4 or higher on a scale of 0 to 10 at the screening.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Count of reported adverse events
Measure the change from baseline in average pain intensity as assessed by the Numeric Pain Rating Scale (NPRS)
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2 RTA 901 Dose 2Experimental Treatment1 Intervention
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.
Group II: Part 2 RTA 901 Dose 1Experimental Treatment1 Intervention
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.
Group III: Part 1 RTA 901 Dose 2Experimental Treatment1 Intervention
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.
Group IV: Part 1 RTA 901 Dose 1Experimental Treatment1 Intervention
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.
Group V: Part 1 PlaceboPlacebo Group1 Intervention
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.
Group VI: Part 2 PlaceboPlacebo Group1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Diabetic Neuropathy, such as gabapentinoids (e.g., gabapentin, pregabalin), antidepressants (e.g., duloxetine, amitriptyline), and anticonvulsants (e.g., oxcarbazepine, lacosamide), work by modulating neural pathways to reduce pain. Gabapentinoids bind to calcium channels, reducing excitatory neurotransmitter release.
Antidepressants increase levels of serotonin and norepinephrine, enhancing inhibitory pain pathways. Anticonvulsants often modulate sodium channels, stabilizing nerve membranes.
These mechanisms are crucial for patients as they address the altered nerve function and pain signaling pathways characteristic of Diabetic Neuropathy, potentially improving quality of life.
Mechanisms and management of diabetic painful distal symmetrical polyneuropathy.
Mechanisms and management of diabetic painful distal symmetrical polyneuropathy.
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Who is running the clinical trial?
BiogenLead Sponsor
644 Previous Clinical Trials
466,985 Total Patients Enrolled
Reata Pharmaceuticals, Inc.Lead Sponsor
51 Previous Clinical Trials
6,516 Total Patients Enrolled
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