What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for diabetic neuropathy include anticonvulsants (e.g., gabapentin, pregabalin), antidepressants (e.g., amitriptyline, duloxetine), and non-opioid analgesics (e.g., NSAIDs). Anticonvulsants can cause dizziness, drowsiness, and peripheral edema. Antidepressants may lead to dry mouth, constipation, and weight gain. NSAIDs are associated with gastrointestinal issues, such as ulcers and bleeding, as well as cardiovascular risks. These side effects should be discussed with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetic neuropathy, particularly for diabetic peripheral neuropathic pain (DPNP). These include gabapentinoids like pregabalin (Lyrica) and gabapentin (Neurontin), which modulate neurotransmitter release to reduce pain. Antidepressants such as duloxetine (Cymbalta) and amitriptyline are also commonly used, leveraging their effects on serotonin and norepinephrine reuptake to manage pain. Additionally, topical agents like the lidocaine patch provide localized pain relief by blocking sodium channels. These treatments aim to alleviate the chronic pain associated with diabetic neuropathy through various mechanisms.

What other types of research exist?

Promising alternatives to RTA 901 for Diabetic Neuropathy patients include: 1) Duloxetine, an SNRI with robust evidence for neuropathic pain relief. 2) DA-9801, a Dioscorea extract showing potential therapeutic applications for diabetic peripheral neuropathy. 3) Topiramate, although previous trials did not reach significance, it remains a consideration. 4) Non-inhaled medical cannabis or cannabinoids for patients with refractory pain. 5) Botulinum toxin injections for focal pain. 6) Ketamine for treatment-refractory neuropathic pain, despite limited evidence.

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RTA 901 for Diabetic Neuropathy (CYPRESS Trial)

Verified Trial

Phase 2

Recruiting

Research Sponsored by Reata, a wholly owned subsidiary of 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 week 12

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 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Average Daily Pain Intensity as Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12

Secondary study objectives

Change From Baseline in the Average Daily Sleep Interference Scale (DSIS) score at Week 12

Number of Participants who Achieved at Least a 30% Decrease From Baseline in the Average NPRS Score at Week 12

Number of Participants who Achieved at Least a 50% Decrease From Baseline in the Average NPRS Score at Week 12

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2 RTA 901 Dose 2Experimental Treatment1 Intervention

Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.

Group II: Part 2 RTA 901 Dose 1Experimental Treatment1 Intervention

Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.

Group III: Part 1 RTA 901 Dose 2Experimental Treatment1 Intervention

Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.

Group IV: Part 1 RTA 901 Dose 1Experimental Treatment1 Intervention

Participants will receive study drug, once daily (QD), during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.

Group V: Part 1 RTA 901-Matching PlaceboPlacebo Group1 Intervention

Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901-matching placebo, QD, for a 12-week treatment duration.

Group VI: Part 2 RTA 901-Matching PlaceboPlacebo Group1 Intervention

0 / 5Eligibility criteria met

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.