ITX24-01 in Adult Male and Female Patients With Select Types of Severe Chronic Neck- and Lower Back Pain

Male or female. Women of childbearing potential must be willing to use contraceptives, or not be sexually active from the time when, during screening, pregnancy was excluded (by history and/or pregnancy test) until after the day of treatment has been completed (until ≥6 hours after administration of the IMP).

Age ≥18 years

Diagnosis of chronic zygapophysial joint neck- or lower back pain and elected to undergo medial branch neurotomy (MBN), aka radiofrequency ablation (RFA), as treatment for that pain syndrome. Participants can be patients who have undergone prior MBN (at the same level and side) and who have experienced pain recurrence and have, at the time of enrollment, opted for a repeat MBN procedure (at the same level and side). A positive MBB as determined by the Principal Investigator (PI) is required for all patients that was performed either at the time of the original diagnosis or at the time of pain recurrence. Thereby, for patients with a new diagnosis of chronic zygapophysial joint neck- or lower back pain (not treated with MBN in the past), a positive diagnostic MBB will be required. For patients with pain recurrence, a positive diagnostic MBB that was performed at the time of the original pain diagnosis, i.e., before the first MBN treatment, will be considered sufficient. (If no diagnostic MBB was performed at the time of the original diagnosis, a diagnostic MBB at the time of recurrence will be required.) The diagnosis will be reviewed by the Principal Investigator (PI) during Screening who will consider the timeline and diagnostic rigor of prior medical findings and tests in conjunction with the evaluation performed during screening (history and physical exam). PI agreement with the diagnosis (at their discretion) is required for the participant to meet this criterion.

Ambulatory