Pregabalin + Duloxetine for Peripheral Neuropathy

Not yet recruiting at 5 trial locations

Overseen By Rachel De Guzman

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Rochester

Must not be taking: Opioids, Duloxetine, Pregabalin, others

Disqualifiers: Opioid use, Other pain diagnoses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 1

Duration: 19 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if quantitative sensory testing (QST) can help doctors identify the most effective pain treatments for individuals with painful peripheral neuropathy (nerve pain in the hands and feet). Participants will try two different medications—pregabalin (an anticonvulsant) and duloxetine (an antidepressant)—along with a placebo, to assess which provides the most pain relief. The study seeks individuals experiencing nerve pain in their feet, described as a burning or tingling sensation, who are currently managing it with stable medication doses. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to developing effective pain management strategies.

Do I have to stop taking my current medications for the trial?

You will need to stay on stable dosages of your current pain medications throughout the study, except for acetaminophen, which can be used as a rescue medication. However, you cannot participate if you are taking certain medications like opioids above a specific dose, duloxetine, pregabalin, or other specified drugs.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that duloxetine is generally safe for treating nerve pain, such as pain from diabetes, with serious side effects being rare. Common side effects include nausea, dry mouth, and fatigue. Research has indicated that pregabalin is also safe for nerve pain, with no major safety concerns. However, some individuals might experience dizziness, sleepiness, or weight gain. Both drugs have been used for other conditions, supporting their safety in treating nerve pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for peripheral neuropathy because they combine pregabalin and duloxetine, two medications that have shown promise individually. Unlike standard treatments that typically focus on either stabilizing nerve signals or altering serotonin and norepinephrine levels, this combination aims to tackle both aspects simultaneously. This dual-action approach could potentially enhance pain relief and improve quality of life more effectively than current options like gabapentin or amitriptyline. By exploring these combinations, researchers hope to provide faster and more comprehensive symptom management for patients.

What evidence suggests that this trial's treatments could be effective for peripheral neuropathy?

Research has shown that duloxetine, one of the treatments in this trial, can effectively reduce pain for people with diabetic peripheral neuropathy. In one study, 45.6% of patients experienced a 50% reduction in pain, and 64.5% had at least a 30% reduction. Pregabalin, another treatment option in this trial, has also significantly lessened pain and improved sleep for those with nerve pain. Both medications have a strong history of managing pain in conditions like peripheral neuropathy. The evidence suggests these treatments could be effective options for managing pain related to peripheral neuropathy. Participants in this trial will receive different sequences of these treatments to evaluate their effectiveness. ^{4 6 7 8 9}

Who Is on the Research Team?

Jennifer Gewandter, PhD, MPH

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for individuals with painful peripheral neuropathy, which can include conditions like diabetic nerve pain. Participants will undergo sensory testing, give a blood sample, and complete questionnaires. They must be able to take the study drugs as instructed.

Inclusion Criteria

Able to understand and read English for informed consent and completing PROs

I have been on a stable pain medication dose for 1 month and can maintain it.

I have nerve pain in a specific area with a confirmed cause and measurable pain levels.

Exclusion Criteria

Evidence of cognitive impairment or psychiatric conditions that may interfere with assessments

Have an active, uncontrolled medical condition, psychotic disorder, or uncontrolled psychiatric illness

Significant risk of suicide or danger to self or others

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo baseline assessments including quantitative sensory testing (QST), blood sample collection, and completion of questionnaires

1 week

1 visit (in-person)

Treatment

Participants receive study drugs (pregabalin, duloxetine, and placebo) in a 3-period cross-over design

19 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Duloxetine
• Placebo
• Pregabalin

Trial Overview The SPENDD trial is testing if quantitative sensory testing (QST) can predict who benefits most from pain treatments in neuropathy patients. It compares the effects of Pregabalin, Duloxetine, and a placebo over 19 weeks using a cross-over design where participants try all three.

How Is the Trial Designed?

Group I: Period 3 - Pregabalin, Duloxetine, Pregabalin, Placebo, Placebo, Duloxetine Experimental Treatment 3 Interventions

Participants will be randomized to 1 of the 6 possible treatment sequences

Group II: Period 2 - Duloxetine, Pregabalin, Placebo, Pregabalin, Duloxetine, Placebo Experimental Treatment 3 Interventions

Participants will be randomized to 1 of the 6 possible treatment sequences

Group III: Period 1 - Placebo, Placebo, Duloxetine, Duloxetine, Pregabalin, Pregabalin Experimental Treatment 3 Interventions

Participants will be randomized to 1 of the 6 possible treatment sequences

Duloxetine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cymbalta for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Fibromyalgia
• Neuropathic Pain
• Chronic Musculoskeletal Pain

Approved in European Union as Cymbalta / Yentreve for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Diabetic Peripheral Neuropathic Pain
• Fibromyalgia
• Stress Urinary Incontinence

Approved in Canada as Cymbalta for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Fibromyalgia
• Neuropathic Pain
• Chronic Musculoskeletal Pain

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10031998/

Efficacy and safety of duloxetine in painful diabetic peripheral ... Furthermore, 45.6% and 64.5% of all patients experienced 50% and 30% pain reduction, respectively, which highlights the clinical efficacy of ...

2. fda.gov fda.gov/files/drugs/published/452_212516%20duloxetine%20unireview%20prea.pdf

NDA/BLA Multi-Disciplinary Review and Evaluation its efficacy and safety. However, the efficacy and safety data of duloxetine delayed-release capsules can be extended from the listed drug ...

3. hhs.texas.gov hhs.texas.gov/sites/default/files/documents/jan-2024-durb-agenda-item5p.pdf

Neuropathic Pain Therapeutic Class Review (TCR) The safety and effectiveness of duloxetine (Cymbalta, Drizalma Sprinkle) in the management of diabetic peripheral neuropathy in patients < 18 ...

4. reference.medscape.com reference.medscape.com/drug/cymbalta-irenka-duloxetine-342960

Cymbalta, Drizalma Sprinkle - duloxetine (Rx) Indicated for diabetic peripheral neuropathy/neuropathic pain. 60 mg PO qDay ... duloxetine decreases effects of iobenguane I 123 by pharmacodynamic antagonism.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12089739/

Efficacy of Duloxetine in the Management of Diabetic ... Duloxetine demonstrated significant efficacy in reducing neuropathic pain and improving nerve conduction parameters in patients with DN over an eight-week ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/212516s002lbl.pdf

drizalma sprinkle - accessdata.fda.gov The safety and effectiveness of DRIZALMA SPRINKLE have not been established in pediatric patients with major depressive disorder (MDD), diabetic peripheral ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/duloxetine-oral-route/description/drg-20067247

Duloxetine (oral route) - Side effects & dosage Duloxetine is used to treat depression and anxiety. It is also used for pain caused by nerve damage associated with diabetes (diabetic peripheral neuropathy).

8. webmd.com webmd.com/drugs/2/drug-91491/cymbalta-oral/details

Duloxetine (Cymbalta, Drizalma Sprinkle) - Uses, Side ... Nerve damage from diabetes that leads to tingling, numbness, burning, or pain, usually in the legs and feet (diabetic peripheral neuropathy) ...

9. drugs.com drugs.com/cons/drizalma-sprinkle.html

Drizalma Sprinkle Advanced Patient Information Duloxetine is used to treat depression and anxiety. It is also used for pain caused by nerve damage associated with diabetes (diabetic peripheral neuropathy).