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 range
35 Years – 85 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Physical, functional and physiological responses to the intervention, as well as unanticipated events
. 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.
. 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)