TTAX03 for the Treatment of Lumbosacral Facet Joint Pain (NCT06236308) | Clinical Trial Compass
WithdrawnPhase 1
TTAX03 for the Treatment of Lumbosacral Facet Joint Pain
Stopped: Study was stopped due to reprioritization for active studies
0Started 2024-07-15
Plain-language summary
This is a pilot study examining the safety and efficacy of a single intra-articular (IA) injection of TTAX03 per joint to relieve severe spinal facet joint (FJ) pain and improve function in subjects with facet joint pain (FJP) in the lumbosacral region. The design is randomized, double blinded, placebo controlled and dose-group sequential.
Who can participate
Age range35 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Able and willing to provide written informed consent
✓. Women of childbearing potential (those who are not premenarchal, not surgically sterilized \[hysterectomy or bilateral oophorectomy\], or not post-menopausal) may participate in the study if they meet all of the following conditions:
✓. ≥ 35 and ≤ 85 years of age
✓. BMI \<40 kg/m2
✓. Clinical suspicion of painful OA of the facet joint(s) in 1 to 4 lumbosacral joints (within 1 - 2 levels) of greater than 3 months duration.
✓. Evidence of OA of the facet in the lumbosacral region on MRI or X-ray within 3 months (e.g., joint space narrowing, the presence of osteophytes and/or subchondral cysts, articular process hypertrophy, subchondral bone sclerosis, articular and subarticular erosions).
✓. NRS score for "worst pain in the past 24 hrs" ≥ 5, using the first NRS value collected in the screening period.
✓. History of having attempted a regimen of conservative care, including physical therapy for ≥ 3 months.
Exclusion criteria
✕. Lactation or pregnancy
✕. Cardiovascular instability as indicated by any of the following identified at screening and verified at least once during the initial screening visit: uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic \>100 mm Hg), uncontrolled arrhythmia or unstable angina pectoris.
What they're measuring
1
Physical, functional and physiological responses to the intervention, as well as unanticipated events
. Cognitive impairment, mental illness, neuroses or untreated depression that would preclude understanding or reliably completing the patient reported outcome measures
✕. History within the past 12 months of gastrointestinal bleeding, myocardial infarction, chronic renal failure, hepatic fibrosis, chronic obstructive pulmonary disease, or hospitalization other than for elective procedures
✕. Non-ambulatory, bedridden, or with active fibromyalgia or central pain syndrome
✕. Hypoesthesia, paresthesia, or allodynia in either foot or leg
✕. Facet OA pain involving more than two levels (i.e., \> 4 FJs)
✕. Use of \> 30 morphine milligram equivalents (MME) per day (see Study Guide)