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Non-Opioid Pramipexole and Pain
EARLY_PHASE1 trial testing Pramipexole Oral Tablet in Chronic Pain in 13 participants. Completed in 15 February 2021.
| Lead sponsor | University of New Mexico |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 1 May 2019 |
| Primary completion | 31 January 2020 |
| Estimated completion | 15 February 2021 |
| Sites | 1 location across United States |
University of New Mexico
18 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Standard Treatment + Placebo | 8 | ± 1 |
| Standard Treatment + Pramipexole | 6.7 | ± 3.2 |
Fold change of the mRNA gene expression from the house keeping gene and the controls.
| Group | Value | 95% CI |
|---|---|---|
| Standard Treatment + Placebo | 16.1 | ± 8.1 |
| Standard Treatment + Pramipexole | 8.6 | ± 8.6 |
Time frame: 4 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Standard Treatment + Placebo | Standard Treatment + Prami… |
|---|---|---|---|
| dizziness | Nervous system disorders | — | — |
Data from ClinicalTrials.gov NCT03842709 adverse events section.
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing