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

NCT01978912 | Completed Phase 1 Results DMC

• 1 other identifier: KTP-001-CL-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (2)

• Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs

  Any clinically significant changes were recorded as adverse events. They are described in the adverse events section of the results. AEs related to MRI, X-ray Imaging, Physical examination, and Neurologic examination are considered as adverse events of special interest (AESI). A treatment-emergent AE (TEAE) was defined as an AE that was not present prior to treatment with study drug, but appeared following treatment or was present at treatment initiation but worsened in severity during treatment.

  24 months

• Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT)

  Assessment of the number of participants with change in 12-lead ECG and CLT were assessed from baseline, 24 hours and 13 weeks.

  13 weeks

Secondary Outcomes (2)

• Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ)

  13 weeks

• Number of Participants With Anti-KTP-001 Antibody

  13 weeks

Other Outcomes (6)

• Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale

  Baseline, 6 weeks and 13 weeks post-dose

• Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test

  Baseline, 6 weeks and 13 weeks post-dose

• Number of Participants With Changes in the Oswestry Disability Index

  Baseline, 6 weeks and 13 weeks post-dose

Study Arms (4)

Cohort 1

EXPERIMENTAL

one time 5 μg/disc dose of KTP-001 by intradiscal injection

Drug: KTP-001

Cohort 2

EXPERIMENTAL

one time 15 μg/disc dose of KTP-001 by intradiscal injection

Drug: KTP-001

Cohort 3

EXPERIMENTAL

one time 50 μg/disc dose of KTP-001 by intradiscal injection

Drug: KTP-001

Cohort 4

EXPERIMENTAL

one time 150 μg/disc dose of KTP-001 by intradiscal injection

Drug: KTP-001

Interventions

KTP-001 DRUG

KTP-001 is one time dose intradiscally.

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Teijin America, Inc.: lead

Study Sites (10)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

HOPE Research Institute, LLC

Phoenix, Arizona, 85018, United States

Location

CORE Orthopaedic Medical Center

Encinitas, California, 92024, United States

Location

California Spine Diagnostic

San Francisco, California, 94115, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Chicago Anesthesia Pain Specialists

Chicago, Illinois, 60657, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: President
• Organization: Teijin America, Inc.

clinical-trials-safety@teijinpo.com

+1-212-308-8744

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 8, 2013
• Study Start: February 1, 2013
• Primary Completion: October 16, 2018
• Study Completion: October 16, 2018
• Last Updated: February 11, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-02

Locations

US (10)