A Study to Evaluate Safety and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation

Completed · Phase 1/Phase 2

Conditions studied: Lumbar Disc Herniation

In brief

The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in subjects with lumbar disc herniation.

Key facts

Study ID

NCT01978912

Run by

Teijin America, Inc.

People needed

24

Starts

2013-02-01

Expected to finish

2018-10-16

Last updated by the study team

2020-02-11

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• HOPE Research Institute, LLC — Phoenix, Arizona, United States
• CORE Orthopaedic Medical Center — Encinitas, California, United States
• California Spine Diagnostic — San Francisco, California, United States
• Compass Research, LLC — Orlando, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Chicago Anesthesia Pain Specialists — Chicago, Illinois, United States
• Central Kentucky Research Associates, Inc. — Lexington, Kentucky, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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