Pregabalin + Duloxetine for Peripheral Neuropathy

Recruiting at 4 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

190 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine whether quantitative sensory testing (QST) can be used to classify participants into pain sub-groups and predict who will respond best to certain pain treatments in participants with painful peripheral neuropathy. The analgesic effect is evaluated by measuring pain intensity and Patient Global Impression of Change (PGIC). This study is a 3-period cross-over trial. This means researchers will compare 3 different drugs (pregabalin, duloxetine, and placebo) over a period of 19 weeks. Participants will: * Undergo a quantitative sensory testing (QST) exam. * Provide a blood sample. * Complete questionnaires on the computer. * Take the study drug as instructed.

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 the combination of Pregabalin and Duloxetine safe for treating peripheral neuropathy?

Pregabalin and Duloxetine are generally safe for treating peripheral neuropathy, but Duloxetine may cause more severe side effects compared to Pregabalin. In one study, severe side effects were observed in 4.6% of patients taking Duloxetine, while no severe side effects were reported for Pregabalin. ^{1 2 3 4 5}

How is the drug combination of Pregabalin and Duloxetine unique for treating peripheral neuropathy?

The combination of Pregabalin and Duloxetine for peripheral neuropathy is unique because it combines two first-line treatments that work differently: Pregabalin, an anticonvulsant, and Duloxetine, an antidepressant. This dual approach may offer enhanced pain relief by targeting different pathways involved in neuropathic pain. ^{1 6 7 8 9}

Research Team

Jennifer Gewandter, PhD, MPH

Principal Investigator

University of Rochester

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

A Prospective Observational Study Comparing the Efficacy and Safety of Duloxetine and Pregabalin in Diabetic Peripheral Neuropathic Pain. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Evaluation of efficacy and safety of gabapentin, duloxetine, and pregabalin in patients with painful diabetic peripheral neuropathy. [2022]

3. Chile pubmed.ncbi.nlm.nih.gov

Duloxetine for the treatment of painful diabetic peripheral neuropathy in Venezuela: economic evaluation. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of the Efficacy and Safety of Pregabalin and Duloxetine in Taxane-Induced Sensory Neuropathy: A Randomized Controlled Trial. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Suboptimal Treatment of Diabetic Peripheral Neuropathic Pain in the United States. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Duloxetine in patients with diabetic peripheral neuropathic pain in Japan: a randomized, doubleblind, noninferiority comparative study with pregabalin. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Pregabalin and duloxetine for the treatment of neuropathic pain disorders. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

Pregabalin for chemotherapy-induced neuropathy: background and rationale for further study. [2023]

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

Comparison of the Efficacy of Duloxetine and Pregabalin in Pain Relief Associated with Diabetic Neuropathy. [2020]