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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
Awards & highlights

CYPRESS Trial Summary

This trial is a 2-part study to assess the safety, tolerability, efficacy, and PK of RTA 901 in DPNP patients. 384 subjects will be randomized into 3 treatment arms; 2 doses of RTA 901 and Placebo. Duration: 20wks, Screening/Run-in/Treatment/Follow-up Periods.

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.Check my eligibility
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.See study design
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.

CYPRESS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

CYPRESS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Count of reported adverse events
Measure the change from baseline in average pain intensity as assessed by the Numeric Pain Rating Scale (NPRS)

CYPRESS 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.

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
466,938 Total Patients Enrolled
Reata Pharmaceuticals, Inc.Lead Sponsor
51 Previous Clinical Trials
6,516 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being observed in this research study?

"Affirmative. The information on clinicaltrials.gov attests that this research project is recruiting patients; the trial was first unveiled on August 21st 2023 and has since been revised as of September 13th 2023. 384 people are needed from 29 different medical sites to take part in the study."

Answered by AI

Has the Food and Drug Administration cleared Part 1 RTA 901 Dose 1 for use?

"Although no data exists to support the efficacy of Part 1 RTA 901 Dose 1, our evaluation team assigned a safety score of 2 due to some existing evidence regarding its security."

Answered by AI

How many healthcare facilities are conducting this research experiment?

"Hope Clinical Research, Inc. in Canoga Park, California, Valley Research - Trials in Fresno, Florida and Clinical Research Institute LLC in Los Angeles are 3 of the 29 sites involved with this trial."

Answered by AI

Are participants being accepted for this trial at the present time?

"Affirmative. The details on clinicaltrials.gov show that this medical trial, launched on August 21st 2023 is currently recruiting patients to join the study. 384 individuals are needed from 29 different locations for enrollment"

Answered by AI

Who else is applying?

What site did they apply to?
Nerve and Muscle Center of Texas
Optimus Medical Group
Boston Clinical Trials, LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1

What questions have other patients asked about this trial?

How long will the study last. And is there any compensation ?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I have not tried anything for my neuropathy. I've tried gabapenton 400 mg not working anymore.
PatientReceived 2+ prior treatments
Using gabapentin still have feet pain when walking. I’m tired of being on my medication. I haven’t seen any substantial relief being on them.
PatientReceived 1 prior treatment
I've tried gabapentin it did not work. I am In constant foot pain. Its starting to get in my hands now.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Revival Research Institute, LLC.: < 24 hours
  2. Clinical Research of West Florida: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (CYPRESS)
2023. "A Phase 2 Study of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (CYPRESS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05895552.
All > Tandem > Knoxville
~256 spots leftby Aug 2026
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