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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: Completed Early Phase 1 study of Chronic Pain, sponsored by University of New Mexi.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in self-reported effect of pain on quality of life. The "Brief Pain Inventory, Short Form," instrument will be used. It records severity (0-10 scale; 10= worst pain) at its worst.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Pramipexole Oral Tablet
Study Locations (1)
New Mexico
- University of New Mexico Hospital - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2021-02-15 |
| Phase | Early Phase 1 |
What the finished NCT03842709 record still lists
NCT03842709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chronic Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03842709's enrollment target sits among peer trials
13 285th of 301 higher than 16 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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