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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Teijin America, Inc.
Sponsor:
Information provided by (Responsible Party):
Teijin America, Inc.
ClinicalTrials.gov Identifier:
NCT01978912
First received: October 22, 2013
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Lumbar Disc Herniation
Drug: KTP-001
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Non-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation

Resource links provided by NLM:


Further study details as provided by Teijin America, Inc.:

Primary Outcome Measures:
  • Safety assessed by Adverse events, Magnetic resonance imaging (MRI), X-ray Imaging, Physical examination, Neurologic examination and Vital signs [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Safety assessed by 12-lead electrocardiogram (ECG) and Clinical laboratory tests [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum concentrations of KTP-001 [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • Anti-KTP-001 antibody [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Lower back pain or leg pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Spinal flexion/tension [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Oswestry disability index (ODI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Short form-12 (SF-12) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient global impression of change (PGI-C) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: February 2013
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KTP-001 (First Cohort; Low Dose) Drug: KTP-001
KTP-001 is one time dose intradiscally.
Experimental: KTP-001 (Second Cohort; Lower Middle Dose) Drug: KTP-001
KTP-001 is one time dose intradiscally.
Experimental: KTP-001 (Third Cohort; Higher Middle Dose) Drug: KTP-001
KTP-001 is one time dose intradiscally.
Experimental: KTP-001 (Fourth Cohort; High Dose) Drug: KTP-001
KTP-001 is one time dose intradiscally.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01978912

Contacts
Contact: Michael Beblavy 215-616-3243 michael.beblavy@iconplc.com

Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States
United States, Arizona
Recruiting
Phoenix, Arizona, United States
United States, California
Recruiting
Encinitas, California, United States
Recruiting
San Francisco, California, United States
United States, Georgia
Recruiting
Atlanta, Georgia, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
United States, Michigan
Recruiting
Royal Oak, Michigan, United States
Sponsors and Collaborators
Teijin America, Inc.
  More Information

No publications provided

Responsible Party: Teijin America, Inc.
ClinicalTrials.gov Identifier: NCT01978912     History of Changes
Other Study ID Numbers: KTP-001-CL-101
Study First Received: October 22, 2013
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hernia
Intervertebral Disk Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 20, 2014