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NCT05074485
Discovery and Analytical Validation of Inflammatory Bio-signatures of the Human Pain Experience
Phase 1 trial testing anakinra in Pain in 70 participants. Currently enrolling.
7 May 2026
Quick facts
| Lead sponsor | Alan Prossin |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 70 |
| Start date | 19 July 2021 |
| Primary completion | 7 May 2026 |
| Estimated completion | 7 May 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- anakinra (ANAKINRA) — full drug profile →
- Placebo
- Nociceptive pain challenge
Conditions studied
- Pain — all drugs for Pain →
Sponsor
Alan Prossin
Who can join
Adults 18 to 65, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The first objective of the study is to evaluate whether a novel bio-signature (derived from a wide range of pro- and anti-nociceptive IL-1 family cytokine activity) will predict pain experienced and also release of underlying endogenous opioid neurotransmitters during an experimental nociceptive pain challenge, which will be performed while simultaneously quantifying mu-opioid receptor activity in the brain via \[11C\]-carfentanil PET neuroimaging in healthy subjects. Another objective is to evaluate whether an anti-inflammatory drug that reduces activation of IL-1b (minocycline) will perturb the balance between pro- and anti-nociceptive IL-1 cytokines and effect a reduction in pain experienced (and endogenous opioids released) during the experimental, nociceptive pain challenge. A final objective is to evaluate performance characteristics (sensitivity, accuracy, dynamic range) of the biosignature for the purpose of predicting post-operative pain.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05074485
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT03265132 — A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD) · Phase 3 · terminated
- NCT02278562 — Nutrition, Inflammation and Insulin Resistance in End Stage Renal Disease-Aim 2 · Phase 2 · completed
Other recruiting trials for Pain
Currently open trials in the same condition.
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- NCT07487610 — Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older · recruiting
- NCT07454993 — The Effect of Music During Colonoscopy · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05074485 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alan Prossin
- Last refreshed: 5 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05074485.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing