LX9211 for Diabetic Neuropathy

(PROGRESS Trial)

Recruiting at 109 trial locations

Overseen By Tracy Newbold

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Lexicon Pharmaceuticals

Must not be taking: Opioids, Topical analgesics, NSAIDs

Disqualifiers: Other painful conditions, Neurolytic therapy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

416 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called LX9211 to see if it can reduce nerve pain in people with diabetes. The drug works by blocking pain signals in the nerves. Researchers want to find out if it is more effective than other treatments. A similar drug was previously tested for similar conditions but its development was halted due to safety concerns.

Will I have to stop taking my current medications?

The trial requires that you stop using opioid medications for diabetic nerve pain at least 2 months before screening and prescription topical pain relievers 3 months before. You also need to stop using NSAIDs at least 2 weeks before screening.

How is the drug LX9211 different from other treatments for diabetic neuropathy?

The drug LX9211 is unique because it is being specifically tested for its ability to treat diabetic neuropathy, a condition where many existing drugs have failed to reverse the damage and only halt its progression. This trial aims to determine if LX9211 can effectively address the underlying issues of diabetic neuropathy, potentially offering a new approach compared to current treatments. ^{1 2 3 4 5}

Eligibility Criteria

Adults over 18 with a BMI between 18.0 and 40.0 kg/m^2, diagnosed with type 1 or type 2 diabetes and suffering from chronic diabetic peripheral neuropathic pain for at least six months can join this study. They must have stable diabetes management for three months and an A1C level of ≤11%. People using opioids, neurolytic therapies, topical analgesics for neuropathy recently, or NSAIDs within two weeks cannot participate.

Inclusion Criteria

Willing to adhere to the prohibitions and restrictions specified in the protocol.

I have diabetes (type 1 or 2) with chronic nerve pain.

I am 18 years old or older.

Exclusion Criteria

I have other painful conditions besides diabetic peripheral neuropathic pain.

I haven't used prescription creams for nerve pain in the last 3 months.

I have had nerve treatment or surgery for diabetic nerve pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LX9211 or placebo, orally, once daily during a blinded treatment period

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LX9211
• Placebo

Trial Overview The trial is testing the effectiveness of a new medication called LX9211 against a placebo in reducing pain caused by diabetic peripheral neuropathy. Participants won't know if they're receiving the actual drug or the placebo as both are blinded.

Participant Groups

Group I: LX9211 Low Dose Experimental Treatment 1 Intervention

LX9211 low dose, orally, once daily during a blinded treatment period.

Group II: LX9211 High Dose Followed by Low Dose Experimental Treatment 1 Intervention

LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.

Group III: LX9211 High Dose Experimental Treatment 1 Intervention

LX9211 high dose, orally, once daily during a blinded treatment period.

Group IV: LX9211 Placebo Placebo Group 1 Intervention

LX9211 matching placebo, orally, once daily during a blinded treatment period.

Who Is Running the Clinical Trial?

Lexicon Pharmaceuticals

Lead Sponsor

Trials

67

Recruited

24,400+

Dr. Mike Exton

Lexicon Pharmaceuticals

Chief Executive Officer

PhD in Neuroscience from the University of Newcastle and PhD in Immunology from the University of Essen, Germany

Dr. Craig Granowitz

Lexicon Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

Pregabalin is strongly recommended as an effective treatment for painful diabetic neuropathy (PDN), based on a systematic review of literature from 1960 to 2008 involving various pharmacological and non-pharmacological interventions.

Other treatments like venlafaxine, duloxetine, and gabapentin are considered probably effective, but many treatments have side effects that may limit their usefulness, highlighting the need for more research on their impact on physical function and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based guideline: Treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Bril, V., England, J., Franklin, GM., et al.[2022]

In a 52-week study involving 57 patients with subclinical diabetic neuropathy, tolrestat significantly improved nerve function compared to placebo, with a notable increase in normalized squatting test results (25 patients on tolrestat vs. 6 on placebo).

Patients taking tolrestat also showed a significant improvement in vibration perception thresholds, while those on placebo experienced a deterioration, suggesting tolrestat's potential role in preventing diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolrestat in the primary prevention of diabetic neuropathy. Giugliano, D., Acampora, R., Marfella, R., et al.[2019]

Pregabalin is strongly recommended as an effective treatment for painful diabetic neuropathy (PDN), based on a systematic review of literature from 1960 to 2008 involving various pharmacologic and nonpharmacologic therapies.

Other treatments like venlafaxine, duloxetine, and gabapentin are considered probably effective for PDN, but many have side effects that may limit their use, highlighting the need for more research on their impact on physical function and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based guideline: Treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Bril, V., England, J., Franklin, GM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Progression rates of diabetic neuropathy in placebo patients in an 18-month clinical trial. Ponalrestat Study Group. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Evidence-based guideline: Treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. [2022]

3. Scotland pubmed.ncbi.nlm.nih.gov

0.075% capsaicin lotion for the treatment of painful diabetic neuropathy: A randomized, double-blind, crossover, placebo-controlled trial. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Tolrestat in the primary prevention of diabetic neuropathy. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Evidence-based guideline: Treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. [2022]