Phase 2
N=24
A Study to Evaluate Safety and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation
Lumbar Disc Herniation
Bottom Line
View on ClinicalTrials.gov: NCT01978912 ↗Enrolled (actual)
24
Serious AEs
16.7%
Results posted
Feb 2020
Primary outcome: Primary: Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs — 6; 6; 6; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KTP-001 (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Teijin America, Inc.
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs |
6; 6; 6; 5; 6; 6 | — |
| PRIMARY Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) |
0; 0; 0; 0; 6; 6 | — |
| SECONDARY Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ) |
6; 6; 6; 6; 0; 0 | — |
| SECONDARY Number of Participants With Anti-KTP-001 Antibody |
6; 6; 6; 6; 0; 0 | — |
Summary
The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in subjects with lumbar disc herniation.
Eligibility Criteria
Inclusion Criteria
- Subject has had a single contained or noncontained (extruded) lumbar disc herniation (L3-L4, L4-L5 or L5-S1) diagnosed by clinical symptoms and/or physical findings and confirmed by MRI.
- Subject has leg pain with a documented positive straight leg raise (SLR) test or femoral stretch test (FST).
- Subject has experiences herniated disc symptoms for at least 6 weeks prior to the study without relief with pain medications and other therapies.
- Subject has a BMI of 18 to 35 kg/m2
Exclusion Criteria
- Subject has a sequestered lumbar disc herniation or intrathecal herniation confirmed by MRI
- Subject has two or more symptomatic lumbar disc herniations
- Previous intradiscal therapeutic intervention or has had any lumbar surgery
- Presence of lumbar spine disease and/or deformity other than a lumbar disc herniation
- Active smoker or is unable to abstain from tobacco use for 2 weeks prior to study injection
- Subject has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
Data sourced from ClinicalTrials.gov (NCT01978912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.