A Phase 3 Study of AGA111 in Patients With Degenerative Disc Disease Undergoing Lumbar Interbody … (NCT06115512) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase 3 Study of AGA111 in Patients With Degenerative Disc Disease Undergoing Lumbar Interbody Fusion
China412 participantsStarted 2023-12-08
Plain-language summary
The primary objective of the study is to assess the overall efficacy of a single intervertebral local administration of AGA111 in patients with degenerative disc disease undergoing lumbar interbody fusion.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Has degenerative disc disease of L3-S1 with low back pain, with or without a history of radiating leg or buttock pain, paresthesia, numbness or weakness secondary to radiculopathy of the corresponding spinal segment;
✓. Has radiographic evidence (e.g., X-ray and CT/magnetic resonance imaging MRI) of degenerative disc disease;
✓. Adults ≥ 18 and ≤ 80 years of age and skeletally mature at the time of surgery;
✓. Plan to undergo a single-level lumbar interbody fusion;
✓. Preoperative ODI score ≥ 30;
✓. Has not respond to conservative treatment (e.g, bed rest, physical therapy, drugs, local injections, manipulation and other non-surgical treatments) for a period of at least 3 months;
✓. Willing and able to comply with the protocol and able to understand and sign the subject's informed consent form (ICF) ;
✓. Female subjects of child-bearing potential must agree to use a highly effective method of birth control during the study and for 1 year after the administration of investigational drug, and must have a negative pregnancy test prior to the randomization.
Exclusion criteria
✕. Has undergone other decompression, fusion, and/or other non-fusion spinal surgery at the spinal segment intended to undergo the surgery prior to the screening (except for transforaminal endoscopic discectomy);
✕. Known other significant lumbar instability;
What they're measuring
1
Overall success rate: Proportion of subjects who achieve overall success.