Non-Opioid Pramipexole and Pain
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Chronic Pain
In brief
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.
Key facts
- Study ID
- NCT03842709
- Run by
- University of New Mexico
- People needed
- 13
- Starts
- 2019-05-01
- Expected to finish
- 2021-02-15
- Last updated by the study team
- 2024-10-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Nonmalignant chronic pain patients at University of New Mexico Pain Clinic, reporting suboptimal pain control, who state an interest to try something new to improve pain relief
- Pain score of 5 or greater (0-10 scale)
- Pain lasting more than 3 months
You may not qualify if…
- Patients who do not speak English or Spanish
- Patients unable to consent
- Women who are not post-menopausal, or who have not undergone an oophorectomy/hysterectomy
- Patients who have chronic pulmonary, kidney or liver disease
- Patients with a body mass index (BMI) ≥35
- Patients with a cancer diagnosis within the last 2 years (except non-melanoma skin cancer)
- Patients who are currently lactating
- Patients with a history of orthostatic hypotension
- Patients diagnosed with a dissociative disorder
- Patients with Parkinson's disease, and/or currently taking dopamine agonist prescription medications
- Prisoners and other institutionalized individuals
Where it is running
- University of New Mexico Hospital — Albuquerque, New Mexico, United States
Full record on ClinicalTrials.gov
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