Pregabalin + Duloxetine for Peripheral Neuropathy
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.12345
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.46789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants undergo baseline assessments including quantitative sensory testing (QST), blood sample collection, and completion of questionnaires
Treatment
Participants receive study drugs (pregabalin, duloxetine, and placebo) in a 3-period cross-over design
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
3
Treatment groups
Experimental Treatment
Participants will be randomized to 1 of the 6 possible treatment sequences
Participants will be randomized to 1 of the 6 possible treatment sequences
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:
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Fibromyalgia
- Neuropathic Pain
- Chronic Musculoskeletal Pain
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Diabetic Peripheral Neuropathic Pain
- Fibromyalgia
- Stress Urinary Incontinence
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Fibromyalgia
- Neuropathic Pain
- Chronic Musculoskeletal Pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester
Lead Sponsor
Beth Israel Deaconess Medical Center
Collaborator
Citations
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 ...
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 ...
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 ...
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.
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 ...
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 ...
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).
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) ...
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).
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