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NCT03842709 · ClinicalTrials.gov registry record · Early Phase 1

Non-Opioid Pramipexole and Pain

A Early Phase 1 study of Chronic Pain, sponsored by University of New Mexi.

Completed
Registry status
Early Phase 1
Development phase
13
Enrollment target
1
Study location

NCT03842709 is a Early Phase 1 study of Chronic Pain that has completed, run by University of New Mexi. The registered enrollment target is 13 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03842709, a Early Phase 1 study of Chronic Pain, has completed, sponsored by University of New Mexi.

COMPLETED
Registry status
Early Phase 1
Development phase
13 participants
Enrollment target
1
Study location

Study Summary

The long-term goal of this proposal is to identify non-opioid drugs that harness endogenous anti-inflammatory mechanisms resulting in the suppression of proinflammatory cytokines such as IL-1ß providing a novel approach to treat chronic pain in people while lacking potential for addictive side effects. Specific Aim I: pramipexole blocks the activation of NLRP3 and consequent production and release of the proinflammatory cytokines IL-1ß, IL-6 and TNF-α, and increases production of the anti-inflammatory cytokine interleukin-10 (IL-10). The goal of Aim I (Phase I) experiments is to examine the specific anti-inflammatory mechanisms of pramipexole on PAMP, DAMP and opioid stimulated immune cells, THP-1 cells will be used. Specific Aim II: pramipexole treatment will provide therapeutic benefit to patients experiencing suboptimal pain relief from current standard therapy with concurrent reduction of TLR4-NLRP3-cytokine expression in peripheral blood mononuclear cells. The goal of Aim II (Phase II) will be to determine the therapeutic benefit of pramipexole for pain, which is a repurposing of this FDA-approved drug with a good safety profile. 1.2. Our overarching hypothesis is that pramipexole will control clinical pain by suppressing the activation of the TLR4-NLRP3-IL-1ß pathway and prevent IL-1ß release from peripheral immune cells. These findings have provided the current impetus to examine pain therapeutic drugs targeting immune-related factors either upstream or downstream of IL-1ß signaling.

Conditions Studied

Chronic Pain

Interventions

  • OTHER Placebo
  • DRUG Pramipexole Oral Tablet

Study Locations (1)

New Mexico

  • University of New Mexico Hospital - Albuquerque

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2019-05-01
Est. Completion 2021-02-15
Phase Early Phase 1

Sponsor

University of New Mexi

76 total trials

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What the Registry Record Tells You About NCT03842709

The ClinicalTrials.gov registry entry for NCT03842709 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (98% lower). The listed sponsor is University of New Mexi, which has 76 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03842709 reports 1 study location spanning 1 distinct geographic area - top geographies include New Mexico.

Frequently Asked Questions

What is clinical trial NCT03842709 about?

NCT03842709 is a clinical study titled "Non-Opioid Pramipexole and Pain". The long-term goal of this proposal is to identify non-opioid drugs that harness endogenous anti-inflammatory mechanisms resulting in the suppression of proinflammatory cytokines such as IL-1ß providing a novel approach to treat chronic pain in people while lacking potential for addictive side effec...

What is the current status of trial NCT03842709?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 13 participants. The study started on 2019-05-01. Estimated completion is 2021-02-15.

What conditions does trial NCT03842709 study?

This clinical trial studies the following conditions: Chronic Pain.

What interventions are being tested in trial NCT03842709?

The interventions under investigation include: Placebo (OTHER), Pramipexole Oral Tablet (DRUG).

Who is sponsoring clinical trial NCT03842709?

This trial is sponsored by University of New Mexi, which has 76 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03842709 being conducted?

This trial has 1 study location across New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.