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Antidepressant

Pregabalin + Duloxetine for Peripheral Neuropathy

Phase 2
Waitlist Available
Led By Jennifer Gewandter, PhD, MPH
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between 18 and 80 years old (inclusive)
Be older than 18 years old
Must not have
Taking any opioid medication with a daily mean morphine equivalent (MME) of greater than 30
Currently taken or have taken duloxetine or pregabalin in the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to end of treatment period at 4 weeks

Summary

"This trial aims to see if a test called quantitative sensory testing (QST) can help categorize people with painful nerve damage into different groups and predict who will benefit most from certain pain treatments. The

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from Pregabalin may include dizziness, sleepiness, and swelling. Duloxetine could cause nausea, dry mouth, or fatigue. Placebos typically have no active ingredients but can lead to perceived side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking opioid medication with a daily dose over 30 MME.
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I have taken duloxetine or pregabalin in the last 6 months.
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I am currently taking medication for depression or other conditions.
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I have a history of chronic kidney or liver disease.
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I have had an amputation of a lower limb.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to end of treatment period at 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to end of treatment period at 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain Intensity
Secondary study objectives
PGIC

Trial Design

3Treatment groups
Experimental Treatment
Group I: Period 3 - Pregabalin, Duloxetine, Pregabalin, Placebo, Placebo, DuloxetineExperimental Treatment3 Interventions
Participants will be randomized to 1 of the 6 possible treatment sequences
Group II: Period 2 - Duloxetine, Pregabalin, Placebo, Pregabalin, Duloxetine, PlaceboExperimental Treatment3 Interventions
Participants will be randomized to 1 of the 6 possible treatment sequences
Group III: Period 1 - Placebo, Placebo, Duloxetine, Duloxetine, Pregabalin, PregabalinExperimental Treatment3 Interventions
Participants will be randomized to 1 of the 6 possible treatment sequences
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duloxetine
2011
Completed Phase 4
~4170
Pregabalin
2005
Completed Phase 4
~6110

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
864 Previous Clinical Trials
544,765 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
852 Previous Clinical Trials
12,930,303 Total Patients Enrolled
Jennifer Gewandter, PhD, MPHPrincipal InvestigatorUniversity of Rochester
~127 spots leftby Jun 2028
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