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XT-150 for Facet Joint Pain

Phase 2
Waitlist Available
Research Sponsored by Xalud Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Complaint of nociceptive, mechanical pain of lumbar spine, in particular pain localized to paramedian axis as opposed to midline or radicular. Radicular pain as a secondary finding may be allowed if it is in addition to mechanical pain and can be clinically distinguished by participant.
LBP (Low Back Pain) worsened by activity or motion of region
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 284
Awards & highlights

Study Summary

This trial is testing a new drug, XT-150, for people with back pain caused by facet joint osteoarthritis. The drug will be given by injection into the facet joints at the affected level of the spine, and participants will be randomly assigned to receive either the study drug or a placebo. The trial will test the safety and efficacy of two different doses of XT-150.

Eligible Conditions
  • Facet Joint Pain
  • Inflammation
  • Back Pain

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have pain in your lower back that is not caused by a specific condition or nerve problem.
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Your lower back pain gets worse when you move or do activities.
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You have been in pain for at least 3 months and previous treatments did not provide enough relief.
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Your facet joints have the right structure for receiving an injection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 284
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 284 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in pain intensity using 0-100 Visual Analog Scale (VAS)
Number of participants reporting abnormal hematology and chemistry parameters, physical examination, and vital signs
Number of participants reporting serious adverse events (SAEs) and non-SAEs
Secondary outcome measures
Change from baseline in International Physical Activity Questionnaire (IPAQ short form) scores
Change from baseline in Oswestry Disability Index (ODI) scores
Change from baseline in Patient Global Assessment (PGA) scores
+1 more
Other outcome measures
Change from baseline on Quality of Life

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 0.45mg XT-150Experimental Treatment1 Intervention
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Group II: 0.15mg XT-150Experimental Treatment1 Intervention
0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Group III: PlaceboPlacebo Group1 Intervention
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XT-150
2020
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

Xalud Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
366 Total Patients Enrolled
Morgan StokesStudy DirectorXalud Therapeutics
Howard Rutman, MDStudy DirectorXalud Therapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial permit the participation of minors?

"According to the guidelines, this trial is open to all adults aged 18 or above up until 90."

Answered by AI

Is it feasible to enroll in this medical experiment?

"This clinical trial seeks seventy-two participants between 18 and 90 years of age with inflammatory symptoms. To be eligible, individuals must identify as male or female, experience Low Back pain that worsens when active, have had a positive diagnostic facet pain block with lidocaine, lack any local or intra-articular infections or tumors causing localized LBP (ex: spondylolysis/pars defect), suffer from osteoarthritis resulting in worst pain at least 50 on the Visual Analog Scale (VAS) 0 to 100 scale; remain on stable analgesic regimen for 4 weeks prior to enrollment; demonstrate inadequate relief from previous therapies"

Answered by AI

How many participants are currently receiving treatment as part of this trial?

"Affirmative. Clinicaltrials.gov details confirm that this trial, which was posted on February 24th 2022, is currently open for recruitment. 72 individuals will be included in the study at 3 separate sites."

Answered by AI

Is there a possibility for prospective participants to join the trial?

"Affirmative. Information on clinicaltrials.gov confirms that this research trial, which was posted on February 24th 2022, is now recruiting volunteers. A total of 72 subjects need to be recruited from 3 different medical facilities."

Answered by AI

Has the FDA granted their stamp of approval to XT-150?

"Our internal evaluation at Power rated XT-150's safety a 2, since the drug has only been subjected to Phase 2 trials with evidence of security but not effectiveness."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
South Carolina
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Center for Clinical Research
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've had radio frequency ablation that has not given any pain relief so I am interested in this trial.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
~24 spots leftby Mar 2025